References

  1. https://adisinsight.springer.com/
  2. https://timesofindia.indiatimes.com/life-style/health-fitness/health-news/wegovy-2-0-novo-nordisks-new-experimental-obesity-drug-shows-cardiovascular-and-blood-pressure-benefits/articleshow/125148171.cms
  3. https://www.businesstoday.in/industry/pharma/story/new-weight-loss-drugs-set-to-shake-up-pharma-in-2026-502434-2025-11-17
  4. https://www.nejm.org/doi/full/10.1056/NEJMoa2502082
  5. https://www.nejm.org/doi/full/10.1056/NEJMoa2502081
  6. https://www.clinicaltrialsarena.com/news/novo-nordisk-takes-a-hit-as-cagrisema-underperforms-in-weight-loss/?cf-view
  7. https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisk-says-trial-with-next-gen-obesity-drug-diabetics-shows-157-weight-2025-03-10/#:~:text=SALES%20ESTIMATES%20'TOO%20OPTIMISTIC',billion%20off%20its%20market%20value.
  8. https://www.nasdaq.com/articles/novo-nordisk-files-nda-next-generation-obesity-drug-cagrisema#:~:text=Novo%20Nordisk%20NVO%20announced%20the,in%20obesity%20patients%20with%20diabetes.
  9. https://www.pharmexec.com/view/novo-nordisk-submits-nda-fda-cagrisema#:~:text=Key%20Takeaways,Stock.adobe.com
  10. https://www.biospace.com/drug-development/takeda-establishes-lead-in-narcolepsy-race-with-back-to-back-phase-iii-wins#:~:text=Takeda's%20oveporexton%20improved%20wakefulness%2C%20attention,a%20broader%20range%20of%20indications.
  11. https://www.mmm-online.com/features/pipeline-report-2025-late-stage-programs-set-to-reshape-treatment/#:~:text=Background:%20Oveporexton%20is%20an%20orexin,$2%20billion%20to%20$3%20billion.
  12. https://www.takeda.com/newsroom/newsreleases/2025/takeda-orexin-data-oveporexton-phase-3-narcolepsy-world-sleep-2025/
  13. https://xtalks.com/drug-approvals-to-watch-in-2026-4537/#:~:text=Zilganersen,condition%20with%20no%20approved%20treatments.
  14. https://www.takeda.com/newsroom/newsreleases/2025/takeda-orexin-data-oveporexton-phase-3-narcolepsy-world-sleep-2025/
  15. https://my.clevelandclinic.org/health/diseases/12147-narcolepsy
  16. https://igmpi.ac.in/news/clinical-research/takedas-oveporexton-shows-strong-phase-iii-results-for-narcolepsy-type-1#:~:text=Placement-,Takeda's%20Oveporexton%20Shows%20Strong%20Phase%20III%20Results%20for%20Narcolepsy%20Type,for%20long%2Dterm%20symptom%20control.
  17. https://pmc.ncbi.nlm.nih.gov/articles/PMC5114175/#:~:text=Current%20treatments%20for%20narcolepsy%20are,development%20of%20hypocretin%20replacement%20therapy.
  18. https://www.sciencedirect.com/science/article/pii/S1389945724003174#:~:text=Treatment%20adherence%20(TA)%20in%20narcolepsy,most%20significant%20barriers%20to%20adherence.
  19. https://www.mayoclinic.org/diseases-conditions/narcolepsy/diagnosis-treatment/drc-20375503#:~:text=There%20is%20no%20cure%20for,These%20medicines%20suppress%20REM%20sleep.
  20. https://www.indiatoday.in/health/video/orforglipron-newest-weight-loss-drug-game-changer-or-looming-risk-2789570-2025-09-18
  21. https://www.fortunebusinessinsights.com/anti-obesity-drugs-market-104783
  22. https://pharma.economictimes.indiatimes.com/news/pharma-industry/eli-lilly-becomes-first-drugmaker-to-hit-trillion-dollar-m-cap-on-weight-loss-demand-boom/125497830#:~:text=Wall%20Street%20estimates%20the%20weight,some%20AI%20stocks%2C%20he%20added.
  23. https://finance.yahoo.com/news/novo-nordisk-trading-obesity-drug-061500298.html
  24. https://www.goldmansachs.com/insights/articles/anti-obesity-drug-market
  25. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02165-8/fulltext
  26. https://www.marketwatch.com/story/lilly-obesity-pill-trial-results-find-a-warmer-reception-on-wall-street-this-time-around-ebffcf94
  27. https://www.clinicaltrialsarena.com/news/eli-lilly-eyes-orforglipron-approval-after-phase-iii-diabetes-trial-success/?cf-view
  28. https://ir.ionis.com/news-releases/news-release-details/ionis-receives-us-fda-breakthrough-therapy-designation#:~:text=%E2%80%93%20First%20and%20only%20investigational%20medicine,vice%20president%20of%20neurology%2C%20Ionis.
  29. https://www.nasdaq.com/press-release/ionis-receives-us-fda-breakthrough-therapy-designation-zilganersen-alexander-disease#:~:text=About%20Alexander%20Disease%20(AxD),no%20approved%20disease%2Dmodifying%20medicines.
  30. https://www.ncbi.nlm.nih.gov/books/NBK562242/#:~:text=Introduction,with%20an%20increase%20in%20severity.
  31. https://medlineplus.gov/genetics/condition/alexander-disease/#inheritance
  32. https://my.clevelandclinic.org/health/diseases/6027-alexander-disease
  33. https://www.sciencedirect.com/science/article/pii/S0959438821001148#:~:text=Abstract,the%20promise%20of%20effective%20treatment.
  34. https://www.narayanahealth.org/blog/alexanders-disease-causes-symptoms-and-treatment-options
  35. Ionis announces positive topline results from pivotal study of zilganersen in Alexander disease | Ionis Pharmaceuticals, Inc.
  36. https://www.narayanahealth.org/blog/alexanders-disease-causes-symptoms-and-treatment-options
  37. https://www.ncbi.nlm.nih.gov/books/NBK1172/#:~:text=Management.,/psychiatric%20manifestations%2C%20and%20sleep.
  38. https://www.sciencedirect.com/science/article/pii/S109037982500056X#:~:text=Gene%20therapy%20has%20become%20a,expand%20access%20to%20innovative%20therapies.
  39. https://www.pharmavoice.com/news/merck-keytruda-subcutaneous-cancer-sales-drug-delivery/761607/#:~:text=That%20same%20year%2C%20Keytruda%20Qlex,development%20at%20Merck%20Research%20Laboratories.
  40. https://www.proactpharmacyservices.com/resource/news/fda-approved-keytruda-qlex-to-offset-original-drugs-patent-expiration-in-2028/500/#:~:text=Categories,steep%20revenue%20decline%20previously%20anticipated.
  41. https://www.biopharmadive.com/news/merck-keytruda-subcutaneous-cancer-sales-drug-delivery/801889/#:~:text=Merck%20this%20week%20launched%20Keytruda,over%20$7%20billion%20by%202032.
  42. https://www.pharmaceutical-technology.com/news/msd-keytruda-qlex-subcutaenous-fda-approval/?cf-view
  43. https://www.aacr.org/patients-caregivers/progress-against-cancer/new-pembrolizumab-formulation-approved-for-subcutaneous-injection/#:~:text=The%20U.S.%20Food%20and%20Drug%20Administration%20(FDA),in%20which%20intravenous%20pembrolizumab%20(Keytruda)%20is%20approved.
  44. https://www.businesswire.com/news/home/20251022622711/en/FDA-Grants-Priority-Review-for-KEYTRUDA-pembrolizumab-and-KEYTRUDA-QLEX-pembrolizumab-and-berahyaluronidase-alfa-pmph-Each-in-Combination-with-Padcev-enfortumab-vedotin-ejfv-for-Certain-Patients-with-Muscle-Invasive-Bladder-Cancer
  45. https://www.pharmabiz.com/NewsDetails.aspx?aid=182015&sid=2#:~:text=The%20FDA%20set%20a%20Prescription,such%20high%20unmet%20medical%20need.%E2%80%9D
  46. https://www.nasdaq.com/articles/will-keytruda-aid-mrks-growth-2026-after-subdued-q3#:~:text=Summit%20believes%20ivonescimab%20has%20the,sales%20in%202026%20and%20beyond.
  47. https://medcitynews.com/2025/09/mercks-injectable-version-of-blockbuster-cancer-drug-keytruda-wins-fda-approval/#:~:text=%E2%80%9CAs%20part%20of%20supporting%20patients,Bristol%20Myers%20Squibb%20drug%20Opdivo.
  48. https://www.tradingview.com/news/zacks:921b1892f094b:0-will-keytruda-aid-mrk-s-growth-in-2026-after-a-subdued-q3/#:~:text=Will%20Keytruda%20Aid%20MRK's%20Growth,%E2%80%94%20TradingView%20News
  49. https://www.merck.com/news/fda-approves-mercks-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-injection-for-subcutaneous-use-in-adults-across-most-solid-tumor-indications-for-keytruda-pem/#:~:text=FDA%20Approves%20Merck's%20KEYTRUDA%20QLEX,Search%20for:
  50. https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-as-perioperative-treatment-for/#:~:text=Search%20for:-,FDA%20Approves%20KEYTRUDA%C2%AE%20(pembrolizumab)%20and%20KEYTRUDA%20QLEX%E2%84%A2%20(,Ineligible%20Muscle%2DInvasive%20Bladder%20Cancer&text=RAHWAY%2C%20N.J.%2D%2D(BUSINESS%20WIRE,regimens%20for%20this%20patient%20population.
  51. https://www.cancer.gov/types/common-cancers
  52. https://www.rheumatologyadvisor.com/news/forzinity-gets-accelerated-approval-for-barth-syndrome/
  53. https://stealthbt.com/stealth-biotherapeutics-announces-fda-accelerated-approval-of-forzinity-elamipretide-hcl-the-first-therapy-for-progressive-and-life-limiting-ultra-rare-genetic-disease-barth-syndrome/
  54. https://stealthbt.com/stealth-biotherapeutics-announces-fda-accelerated-approval-of-forzinity-elamipretide-hcl-the-first-therapy-for-progressive-and-life-limiting-ultra-rare-genetic-disease-barth-syndrome/#:~:text=The%20disease%20is%20associated%20with,for%20patients%20with%20Barth%20syndrome.&text=Stealth%20BioTherapeutics'%20mission%20is%20to,ophthalmic%20and%20neurological%20disease%20indications.
  55. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-cleared-pricey-rare-disease-drug-over-reviewer-objections-2025-11-05/
  56. https://www.mordorintelligence.com/industry-reports/emulsion-coatings-market#:~:text=The%20market%20analysis%20includes%20a%20detailed%20examination,market%2C%20including%20industry%20trends%20and%20market%20predictions.
  57. https://stealthbt.com/stealth-biotherapeutics-announces-fda-accelerated-approval-of-forzinity-elamipretide-hcl-the-first-therapy-for-progressive-and-life-limiting-ultra-rare-genetic-disease-barth-syndrome/#:~:text=Contact-,Stealth%20BioTherapeutics%20Announces%20FDA%20Accelerated%20Approval%20of%20FORZINITY%E2%84%A2%20(elamipretide,)%20(approximately%2066%20pounds).
  58. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-first-treatment-barth-syndrome
  59. https://medlineplus.gov/genetics/condition/barth-syndrome/#:~:text=Description,can%20lead%20to%20heart%20failure.
  60. https://www.ncbi.nlm.nih.gov/books/NBK247162/#:~:text=Clinical%20characteristics.,identified%20by%20molecular%20genetic%20testing.
  61. https://www.gimjournal.org/article/S1098-3600(21)04946-7/fulltext
  62. https://my.clevelandclinic.org/health/diseases/23219-barth-syndrome
  63. https://onlinelibrary.wiley.com/doi/full/10.1002/jimd.12453
  64. https://www.childrenshospital.org/conditions-treatments/barth-syndrome#:~:text=How%20is%20Barth%20syndrome%20treated,has%20not%20responded%20to%20medicine
  65. https://s206.q4cdn.com/492797646/files/doc_financials/2025/q3/FINAL_CRNX-Q3-25-Earnings-PR.pdf
  66. https://crinetics.com/crinetics-announces-fda-approval-of-palsonify-paltusotine-for-the-treatment-of-acromegaly-in-adults/#:~:text=A%20Marketing%20Authorization%20Application%20(MAA,PALSONIFY%E2%84%A2%20(paltusotine)%20INDICATION:
  67. https://www.patientcareonline.com/view/fda-approves-paltusotine-as-first-once-daily-oral-therapy-for-acromegaly-in-adults#:~:text=The%20company%20noted%20that%20a,global%20enrollment%20underway%20in%202025.&text=References:,%2D1%2Dacromegaly%2Dstudy/
  68. https://www.investing.com/news/swot-analysis/crinetics-pharmaceuticals-swot-analysis-oral-endocrine-drug-stock-poised-for-growth-93CH-4277900
  69. https://in.investing.com/news/analyst-ratings/crinetics-stock-price-target-raised-to-143-from-86-at-jmp-on-palsonify-approval-93CH-5020722
  70. https://fintel.io/topic/what-are-the-projected-revenue-impacts-of-palsonifys-fda-approval-on-september-25-2025-1781-2632#:~:text=Comments%20(1)%20Approval%20and%20Commercialization:%20Crinetics%20(,October.%20Historical%20Revenue:%20Financial%20Position:%20Market%20Potential:
  71. https://www.mayoclinic.org/diseases-conditions/acromegaly/symptoms-causes/syc-20351222
  72. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-acromegaly-rare-endocrine-disorder
  73. https://www.endocrine-abstracts.org/ea/0099/ea0099ep462#:~:text=Conclusion:%20Despite%20many%20advances%20in,evaluating%20patients%20in%20experienced%20centers.
  74. https://pmc.ncbi.nlm.nih.gov/articles/PMC4935749/#:~:text=Successful%20management%20of%20acromegaly%20goes,approach%20with%20comprehensive%20comorbidity%20management.
  75. https://www.nejm.org/doi/full/10.1056/NEJMra2409076
  76. https://allergyasthmanetwork.org/news/btk-inhibitor-for-csu/#:~:text=It%20blocks%20or%20slows%20the,to%20consider%20more%20advanced%20medications.
  77. https://www.hcplive.com/view/fda-approves-remibrutinib-chronic-spontaneous-urticaria#:~:text=Key%20Takeaways,the%20current%20standard%20biologic%20treatment.
  78. https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-rhapsido-remibrutinib-only-oral-targeted-btki-treatment-chronic-spontaneous-urticaria-csu#:~:text=Basel%2C%20September%2030%2C%202025%20%E2%80%93,symptomatic%20despite%20H1%20antihistamine%20treatment.
  79. https://www.clinicaltrialsarena.com/features/multiple-sclerosis-ms-trials-to-watch-phase-iii/#:~:text=Novartis%20seeks%20MS%20scope%20expansion,to%20all%20other%20available%20therapies.%E2%80%9D
  80. https://business.optum.com/en/insights/notable-new-drugs-report-fall-2025.html#:~:text=In%20addition%20to%20other%20injectable,with%20potential%20approval%20in%202026.
  81. https://xtalks.com/rhapsido-remibrutinib-approved-as-first-oral-btk-inhibitor-for-chronic-spontaneous-urticaria-4421/
  82. https://www.msn.com/en-us/money/companies/novartis-upgraded-at-morgan-stanley-on-stock-pullback-rhapsido-launch/ar-AA1RDZ5M#:~:text=Seeking%20Alpha-,Novartis%20upgraded%20at%20Morgan%20Stanley%20on%20stock%20pullback%2C%20Rhapsido%20launch,to%20surpass%20the%20consensus%20estimate.
  83. https://www.fiercepharma.com/pharma/novartis-kicks-btk-competition-immunology-fda-approval-remibrutinib-chronic-hives#:~:text=The%20Novartis%20drug%20recently%20showed,the%20end%20of%20the%20decade.
  84. https://www.drugpatentwatch.com/p/tradename/RHAPSIDO#:~:text=Upfront%20development%20expenses,5.1%20Opportunities
  85. https://in.investing.com/news/stock-market-news/morgan-stanleys-top-european-pharmaceutical-picks-for-investors-93CH-5138446
  86. https://www.gurufocus.com/news/3236538/novartis-nvs-upgraded-by-morgan-stanley-on-rhapsido-launch-optimism?mobile=true
  87. https://www.mayoclinic.org/diseases-conditions/chronic-hives/symptoms-causes/syc-20352719#:~:text=Welts%20that%20vary%20in%20size%2C%20change%20shape%2C%20and%20appear%20and,Mayo%20Clinic%20to%20your%20inbox
  88. https://pmc.ncbi.nlm.nih.gov/articles/PMC3276885/#:~:text=Abstract,have%20a%20tendency%20to%20recur.
  89. https://my.clevelandclinic.org/health/diseases/22900-chronic-hives-chronic-idiopathic-urticaria
  90. https://pmc.ncbi.nlm.nih.gov/articles/PMC2807703/#:~:text=Abstract,methotrexate%2C%20cyclosporine%2C%20omalizumab%20etc.
  91. https://pmc.ncbi.nlm.nih.gov/articles/PMC3800585/#:~:text=must%20be%20avoided.-,Reality.,the%20%E2%80%9Cepisode%E2%80%9D%20settles%20down.
  92. https://www.ncbi.nlm.nih.gov/books/NBK555910/#:~:text=Clinicians%20should%20counsel%20patients%20not,a%20good%20quality%20of%20life.
  93. https://medshadow.org/drug-updates-recalls/drug-safety/what-to-know-about-lynkuet-the-new-hot-flash-drug/#:~:text=on%20this%20page:&text=On%20October%2024%2C%202025%2C%20the,it%20performs%20over%20several%20years.%E2%80%9D
  94. https://www.bayer.com/media/en-us/bayers-lynkuet-elinzanetant-approved-in-the-us-for-treatment-of-moderate-to-severe-vasomotor-symptoms-due-to-menopause/
  95. https://www.hcplive.com/view/nonhormonal-therapies-transform-hot-flash-treatment-in-menopause#:~:text=In%202025%2C%20major%20shifts%20to,caused%20by%20declining%20estrogen%20levels.
  96. https://pubmed.ncbi.nlm.nih.gov/18074100/#:~:text=Abstract,involved%20in%20maintaining%20temperature%20homeostasis.
  97. https://www.webmd.com/menopause/menopause-vasomotor-symptoms
  98. https://pmc.ncbi.nlm.nih.gov/articles/PMC10198127/#:~:text=Abstract,warrant%20focused%20CVD%20prevention%20efforts.
  99. https://www.sciencedirect.com/science/article/pii/S0378512216304030#:~:text=Abstract,symptoms%20and%20the%20metabolic%20syndrome.
  100. https://www.medicalnewstoday.com/articles/317801#symptoms
  101. https://pmc.ncbi.nlm.nih.gov/articles/PMC12234229/#:~:text=Vasomotor%20symptoms%20are%20among%20the,be%20recommended%20as%20effective%20treatments.
  102. https://www.sciencedirect.com/science/article/pii/S037851222400166X
  103. https://touchendocrinology.com/reproductive-endocrinology/journal-articles/contemporary-non-hormonal-therapies-for-the-management-of-vasomotor-symptoms-associated-with-menopause-a-literature-review/
  104. https://www.otsuka.co.jp/en/company/newsreleases/2025/20251126_1.html#:~:text=Continued%20approval%20for%20this%20indication,in%20our%20clinical%20trial%20program.%22
  105. https://reachmd.com/news/regulatory-milestones-and-clinical-impact-of-otsukas-voyxact-in-iga-nephropathy-treatment/2484695/#:~:text=This%20surrogate%2Dbased%20approval%20thus,duration%20and%20sequencing%20of%20therapy.
  106. https://checkrare.com/fda-approves-voyxact-for-primary-immunoglobulin-a-nephropathy/#:~:text=The%20approval%20is%20based%20on,to%20be%20available%20early%202026.
  107. https://www.cliniexpert.com/article/1124.html#:~:text=About%20Voyxact%C2%AE%20(sibeprenlimab%2Dszsi,injection%20dosed%20every%20four%20weeks.
  108. https://www.pharmavoice.com/news/drug-approvals-2025-fda-gilead-vertex-kura-otsuka/807197/#:~:text=The%20FDA%20gave%20the%20go,$6%20billion%20to%20$10%20billion.
  109. https://www.otsuka.com/en/ir/management/plan.html#:~:text=The%204th%20Medium%2DTerm%20Management%20has%20been%20positioned%20as%20a,Revenue%20forecast%20for%20growth%20drivers
  110. https://xtalks.com/voyxact-becomes-first-biologic-approved-for-iga-nephropathy-as-competitors-advance-4515/#:~:text=According%20to%20analysts%20at%20Jefferies,Newsletter%20and%20Xtalks%20Webinars%20list.
  111. https://www.mayoclinic.org/diseases-conditions/iga-nephropathy/symptoms-causes/syc-20352268#:~:text=This%20causes%20inflammation%20and%20affects,HIV%20and%20some%20bacterial%20infections.
  112. https://www.forbes.com/sites/jamesfarrell/2024/04/03/what-to-know-about-jiyoutai-chinas-first-potential-ozempic-challenger/
  113. https://manoxblog.com/2025/04/04/biosimilar-ozempic-on-the-horizon/#:~:text=The%20move%20could%20pose%20challenges,celltrion%2Domalizumab%2Dbiosimilar%2Dsubmission
  114. https://www.grandviewresearch.com/market-trends/semaglutide-market-navigating-patent-cliff-strategic-implications#:~:text=Patent%20Cliff%20Analysis,of%20patents%20in%20these%20regions.
  115. https://www.globaldata.com/media/pharma/semaglutide-patent-cliff-present-substantial-opportunity-companies-chinese-generics-market-says-globaldata/#:~:text=Nadim%20Anwer%2C%20Pharma%20Analyst%20at%20GlobalData%2C%20comments:,will%20drive%20increased%20competition%20and%20lower%20prices.%E2%80%9D
  116. https://www.drugpatentwatch.com/blog/the-unseen-connection-turning-drug-patent-data-into-supply-chain-gold/#:~:text=For%20a%20biosimilar%2C%20the%20potential%20launch%20window,lawsuits%20challenging%20different%20parts%20of%20the%20thicket.
  117. https://www.market-scope.com/pages/news/8182/2024-and-quarterly-ophthalmic-revenue-roundup-for-regeneron-carl-zeiss-meditec-hoya-and-staar
  118. https://investor.regeneron.com/news-releases/news-release-details/regeneron-receives-six-months-us-pediatric-exclusivity-eylear/#:~:text=About%20EYLEA,profits%20from%20sales%20of%20EYLEA.
  119. https://investor.regeneron.com/news-releases/news-release-details/regeneron-provides-business-updates-and-highlights-broad/
  120. https://investor.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-data-euretina-reinforce#:~:text=Bayer%20has%20licensed%20the%20exclusive%20marketing%20rights,and%20EYLEA%20HD%20following%20any%20regulatory%20approvals.
  121. https://www.centerforbiosimilars.com/view/a-banner-year-for-biosimilars-the-18-fda-approvals-from-2024
  122. https://www.jdsupra.com/legalnews/biologics-and-biosimilars-landscape-4838612/#:~:text=Yesafili%E2%84%A2%20and%20Opuviz%E2%84%A2,for%20their%20respective%20reference%20products.&text=As%20of%20the%20end%20of,have%20launched%20in%20the%20U.S.
  123. https://gabionline.net/reports/ema-approved-a-record-28-biosimilars-in-2024#:~:text=threaten%20foreign%20biosimilars-,General,previously%20unapproved%20in%20the%20EU.
  124. https://www.drugs.com/medical-answers/many-biosimilars-approved-united-states-3463281/#:~:text=Is%20there%20a%20list%20of,existing%20FDA%2Dapproved%20reference%20product.
  125. https://www.gabionline.net/biosimilars/news/ema-recommends-approval-for-nine-biosimilars#:~:text=Denosumab%20biosimilars&text=The%20originator%20products%20are%20Amgen's,with%20interchangeable%20designation%20%5B2%5D.
  126. https://www.statista.com/statistics/1636035/novo-nordisk-ozempic-net-sales/#:~:text=Table_title:%20Ozempic%20net%20sales%20of%20Novo%20Nordisk,Net%20sales%20in%20million%20DKK:%2095.72%20%7C
  127. https://www.reuters.com/business/healthcare-pharmaceuticals/chinas-first-biosimilar-ozempic-drug-applies-approval-2024-04-03/?utm
  128. https://www.hindustantimes.com/business/after-india-novo-nordisk-cuts-wegovy-price-in-china-on-generics-challenge-101767071403560.html?utm
  129. https://www.business-standard.com/companies/news/novo-nordisk-moves-hc-to-stop-sun-pharma-from-launching-weight-loss-drug-125120901316_1.html?utm
  130. https://www.livemint.com/companies/news/weightloss-drug-wegovy-patent-dispute-novo-nordisk-dr-reddys-ozempic-drugmakers-11764663483106.html?utm
  131. https://www.pearceip.law/2025/11/26/boan-biotechs-biosimilar-aflibercept-approved-in-china/?utm
  132. https://medicaldialogues.in/news/industry/pharma/biocon-targets-launch-for-generic-wegovy-in-india-by-2027-151950?utm
  133. https://www.centerforbiosimilars.com/view/eye-on-pharma-biosimilar-ozempic-biocon-mylan-merger-celltrion-omalizumab-biosimilar-submission?utm
  134. https://www.pearceip.law/2025/08/18/teva-subsidiary-to-launch-unbranded-ustekinumab-biosimilar-in-us-via-medimpact/#:~:text=News%20/%20BioBlast%C2%AE-,Teva%20Subsidiary%20to%20Launch%20Unbranded%20Ustekinumab%20Biosimilar%20in%20US%20via,biosimilar%20from%2021%20February%202025.
  135. https://www.pharmaindustrial-india.com/news/medimpact-to-launch-affordable-unbranded-biosimilar-ustekinumab-aekn-in-2026#:~:text=Drug%20Discovery%20&%20Development-,MedImpact%20to%20Launch%20Affordable%20Unbranded%20Biosimilar%20Ustekinumab%2Daekn%20in%202026,offering%20broader%20industry%2Dwide%20benefits.
  136. https://www.medimpact.com/clients/resources/press-releases/medimpact-offers-low-cost-unbranded-ustekinumab-aekn-biosimilar#:~:text=%E2%80%9CThe%20unbranded%20ustekinumab%2Daekn%2C,contact%20info@medimpact.com.
  137. https://civicarx.org/civicascript-to-distribute-low-cost-biosimilar-to-treat-chronic-inflammatory-conditions/#:~:text=Ustekinumab%2Daauz%20is%20available%20in%20prefilled%20syringes%20in,*%20Health%20plans%20*%20Pharmacy%20benefit%20managers
  138. https://www.pearceip.law/2025/11/19/adalimumab-omalizumab-and-ustekinumab-biosimilars-on-march-2026-pbac-agenda/#:~:text=News%20/%20BioBlast%C2%AE-,Adalimumab%2C%20Omalizumab%20and%20Ustekinumab%20Biosimilars%20on%20March%202026%20PBAC%20Agenda,will%20be%20considered%20for%20reimbursement:
  139. https://www.lexology.com/library/detail.aspx?g=a394336b-906e-4570-9b5b-507cdbe46586#:~:text=Adalimumab%2C%20Omalizumab%20and%20Ustekinumab%20Biosimilars%20on%20March%202026%20PBAC%20Agenda%20%2D%20Lexology
  140. https://gabionline.net/biosimilars/general/the-ustekinumab-shift-biosimilars-displace-stelara-s-market-leadership#:~:text=Global%20Stelara%20sales%20dropped%2014.7,%2C%20Biocon%2C%20and%20Samsung%20Bioepis.
  141. https://www.grandviewresearch.com/market-trends/ustekinumab-market-strategic-shifts-post-patent-expiry-biosimilar-impact#:~:text=Current%20Market%20Scenarios&text=The%20global%20Ustekinumab%20market%20x,with%20strong%20cost%20containment%20measures.
  142. https://www.metatechinsights.com/industry-insights/ustekinumab-market-2325#:~:text=What%20trends%20will%20shape%20this,treat%20chronic%20autoimmune%20diseases%20effectively.
  143. https://www.valueinhealthjournal.com/article/S1098-3015(24)03162-0/fulltext#:~:text=Conclusions,protection%20for%20the%20reference%20medicine.
  144. https://www.cardinalhealth.com/content/dam/corp/web/documents/literature/cardinal-health-ustekinumab-article.pdf
  145. https://pmc.ncbi.nlm.nih.gov/articles/PMC8438344/#:~:text=It%20is%20predicted%20that%20the,such%20as%20cancer%20and%20neutropenia.
  146. https://academic.oup.com/healthaffairsscholar/article/3/11/qxaf222/8328279
  147. https://www.cognitivemarketresearch.com/biosimilar-drug-market-report#:~:text=Product%20Launches:&text=The%20launch%20of%20biosimilars%20for,for%20subcutaneous%20and%20intravenous%20use.
  148. https://www.biopharmadive.com/spons/apples-to-apples-stelara-biosimilars-and-the-fight-for-market-share/753098/#:~:text=If%20payers%20evaluate%20ustekinumab%20biosimilars,%2C%20beginning%20January%201%2C%202026.
  149. https://insights.citeline.com/generics-bulletin/products/biosimilars/roche-braces-for-late-2026-biosimilar-wave-6VTOL2ZMGJEAPDBMSAFPEPP6M4/#:~:text=Perjeta%20And%20Xolair%20Expected%20To,%2C%20marking%20a%20newly...
  150. https://www.pearceip.law/2025/07/24/roche-revises-expectations-of-biosimilar-competition-to-pertuzumab-and-omalizumab/#:~:text=Roche%20Revises%20Expectations%20of%20Biosimilar%20Competition%20to%20Pertuzumab%20and%20Omalizumab,-Jul%2024%2C%202025&text=Roche's%202025%20second%2Dquarter%20earnings,least%20the%20UK%20and%20Europe.
  151. https://www.pulmonologyadvisor.com/news/omalizumab-interchangeable-biosimilar-omlyclo-gets-fda-approval/#:~:text=Omlyclo%20is%20supplied%20as%20a,early%20as%20September%201%2C%202026.&text=References:,16446
  152. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-BLA-Submission-of-Biosimilar-Candidate-to-XOLAIR-omalizumab/default.aspx
  153. https://www.sps.nhs.uk/articles/preparing-to-use-omalizumab-biosimilar/#:~:text=The%20NHS%20framework%20is%20not,biosimilar;%20brand%20name%20currently%20unknown
  154. https://www.tandfonline.com/doi/full/10.1080/13696998.2025.2558450#abstract
  155. https://pubmed.ncbi.nlm.nih.gov/40955168/#:~:text=Sensitivity%20analysis%20applying%2050%25%20and,Biosimilar%20Pharmaceuticals*%20/%20economics
  156. https://www.pearceip.law/2025/07/24/roche-revises-expectations-of-biosimilar-competition-to-pertuzumab-and-omalizumab/#:~:text=News%20/%20BioBlast%C2%AE-,Roche%20Revises%20Expectations%20of%20Biosimilar%20Competition%20to%20Pertuzumab%20and%20Omalizumab,2026%2C%20sooner%20than%20previously%20anticipated.
  157. https://www.researchgate.net/publication/395550514_Budget_impact_of_introducing_an_omalizumab_biosimilar_in_23_European_countries
  158. https://www.linkedin.com/pulse/omalizumab-biosimilars-market-cagr-2026-2033-key-highlights-pcg3f/
  159. https://manoxblog.com/2025/10/09/omalizumab-biosimilar-submissions-signal-market-competition/#:~:text=This%20therapeutic%20market%20is%20large,growth%20driver%20for%20the%20company.
  160. https://www.pearceip.law/2025/07/24/roche-revises-expectations-of-biosimilar-competition-to-pertuzumab-and-omalizumab/#:~:text=Roche%20Revises%20Expectations%20of%20Biosimilar%20Competition%20to%20Pertuzumab%20and%20Omalizumab,-Jul%2024%2C%202025&text=Roche's%202025%20second%2Dquarter%20earnings,least%20the%20UK%20and%20Europe.
  161. https://insights.citeline.com/generics-bulletin/products/biosimilars/roche-braces-for-late-2026-biosimilar-wave-6VTOL2ZMGJEAPDBMSAFPEPP6M4/#:~:text=Perjeta%20And%20Xolair%20Expected%20To,%2C%20marking%20a%20newly
  162. https://www.researchandmarkets.com/reports/6143271/pertuzumab-biosimilars-market-global-forecast#:~:text=The%20Pertuzumab%20Biosimilars%20Market%20grew,strategic%20imperatives%20shaping%20future%20success
  163. https://www.statista.com/statistics/1453304/perjeta-global-revenue/
  164. https://finance.yahoo.com/news/her2-positive-breast-cancer-treatment-123000015.html
  165. https://www.drugpatentwatch.com/p/biologics/ingredient/omalizumab?srsltid=AfmBOopoQaCXJ1P5bMswMaW57Hg5CSOKkha2WBj462yCmy23bwlSUSF0
  166. https://www.absolutereports.com/global-omalizumab-biosimilars-market-20646981
  167. https://www.celltrion.com/en-us/company/media-center/press-release/3125#:~:text=The%20Celltrion%20application%20for%20CT,November%202025%20in%20the%20U.S.
  168. https://www.pharmaceutical-technology.com/news/xolair-amplifies-reach-after-fda-approval-for-treating-food-allergies/#:~:text=However%2C%20despite%20this%20expanded%20use,November%202025%20in%20the%20US.
  169. https://www.drugdiscoverytrends.com/dupixent-bests-xolair-in-first-head-to-head-respiratory-trial-4-takeaways/#:~:text=In%20contrast%2C%20Roche's%20Xolair%20recorded%20$4%20billion%20in%202024%20sales.
  170. https://www.merck.com/news/u-s-district-court-rules-in-favor-of-merck-in-sitagliptin-phosphate-patent-lawsuit/#:~:text=In%20addition%2C%20Merck%20has%20entered,to%20the%20market%20in%20July
  171. https://www.fiercepharma.com/pharma/merck-defending-its-blockbuster-januvia-prevails-patent-lawsuit-against-viatris#:~:text=They%20provide%20intellectual%20property%20protections,earlier%20%22under%20certain%20circumstances.%22
  172. https://www.rxlist.com/januvia-drug.htm
  173. https://www.genengnews.com/topics/drug-discovery/top-20-drugs-heading-for-the-patent-cliff-2026-2029/
  174. https://www.fiercepharma.com/pharma/merck-defending-its-blockbuster-januvia-prevails-patent-lawsuit-against-viatris#:~:text=Earlier%20this%20year%2C%20Merck%20said,and%20polymorphic%20forms%20until%202027.%22
  175. https://pharmatradz.com/pharma-articles/blogs/top-revenue-losing-drugs-after-patent-expiry-their-api-market-potential
  176. https://www.sec.gov/Archives/edgar/data/310158/000031015816000063/mrk1231201510k.htm#:~:text=Number%20of%20shares%20of%20Common,June%2030%2C%202015:%20$160%2C710%2C000%2C000.
  177. https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2016-who-sold-the-blockbuster-drugs#:~:text=The%20top%2Dsellers,plaque%20psoriasis%2C%20to%20ulcerative%20colitis.
  178. https://www.forbes.com/sites/greatspeculations/2018/06/27/mercks-alimentary-metabolism-drug-sales-have-likely-peaked/
  179. https://www.sec.gov/Archives/edgar/data/310158/000031015819000014/mrk1231201810k.htm#:~:text=Table_content:%20row:%20%7C%20($%20in%20millions)%20%7C,row:%20%7C%20Januvia/Janumet%20%7C%205%2C914%20%7C%20%7C
  180. https://www.forbes.com/sites/greatspeculations/2018/06/27/mercks-alimentary-metabolism-drug-sales-have-likely-peaked/
  181. https://www.beckershospitalreview.com/pharmacy/13-leading-drugmakers-top-3-drugs-by-revenue-in-2020/#:~:text=The%20three%20top%20drugs%20by,Prolia%20%E2%80%94%20$2.76%20billion
  182. https://www.drugpatentwatch.com/p/tradename/januvia
  183. https://www.drugpatentwatch.com/p/tradename/januvia
  184. https://xtalks.com/top-15-diabetes-drugs-in-2023-by-2022-sales-statistics-3715/#:~:text=This%20article%20delves%20into%20the,healthcare%20providers%20and%20industry%20stakeholders.&text=Januvia%20(Sitagliptin)
  185. https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2023-financial-results/#:~:text=Pharmaceutical%20sales%20growth%20in%202023%20was%20partially,sales%20of%20PNEUMOVAX%2023%20as%20the%20market
  186. https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/#:~:text=Full%2Dyear%202024%20pharmaceutical%20sales,grew%204%25%20to%20$5.9%20billion
  187. https://www.reuters.com/business/healthcare-pharmaceuticals/mercks-bridion-faces-generic-threat-drugmaker-hikma-2024-02-26/#:~:text=Bridion%2C%20chemically%20known%20as%20sugammadex,2026.
  188. https://intuitionlabs.ai/articles/drug-patent-expirations-2026
  189. https://www.biospace.com/merck-s-bridion-could-face-generic-pressure-from-hikma-ahead-of-patent-expiry-date#:~:text=In%20June%202023%2C%20the%20U.S.,in%20Japan%20and%20in%20China.
  190. https://www.biospace.com/merck-s-bridion-could-face-generic-pressure-from-hikma-ahead-of-patent-expiry-date#:~:text=In%20June%202023%2C%20the%20U.S.,in%20Japan%20and%20in%20China.
  191. https://www.greyb.com/blog/drug-patents-expiring-2026/#:~:text=Table_title:%20Bridion%20Table_content:%20header:%20%7C%20Patents%20%7C,%7C%20Expiration%20Date:%20January%2027%2C%202026%20%7C
  192. https://www.drugs.com/availability/generic-bridion.html#:~:text=Yes%2C%20the%20FDA%20has%20approved%20a%20generic,selling%20the%20generic%20even%20after%20FDA%20approval.
  193. https://intuitionlabs.ai/articles/drug-patent-expirations-2026
  194. https://www.jocpr.com/articles/the-impact-of-patent-expirations-on-the-pharmaceutical-industry-10233.html#:~:text=Description,and%20patients%20through%20cost%20savings.
  195. https://www.drugpatentwatch.com/blog/the-impact-of-patent-expirations-on-generic-drug-markets/#:~:text=Section%204:%20When%20the%20Levee,aiming%20for%20rapid%20market%20capture.
  196. https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2015-financial-results/
  197. https://www.sec.gov/Archives/edgar/data/310158/000031015817000010/mrk1231201610k.htm
  198. https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2017-financial-results/#:~:text=Worldwide%20sales%20were%20$10.4%20billion%20for%20the%20fourth%20quarter%20of,with%20the%20fourth%20quarter%20of
  199. https://www.sec.gov/Archives/edgar/data/310158/000031015818000005/mrk1231201710k.htm#:~:text=In%20addition%2C%20in%20the%20effort%20to%20contain,include%20additional%20direct%20price%20controls%20in%20the
  200. https://www.sec.gov/Archives/edgar/data/310158/000031015819000014/mrk1231201810k.htm#:~:text=The%20total%20annual%20industry%20fee%20was%20$4.1,sales%20to%20certain%20government%20programs%2C%20such%20as
  201. https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2019-financial-results/#:~:text=Fourth%2DQuarter%202019%20Worldwide%20Sales,Exchange%20of%20Less%20Than%201%25
  202. https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2020-financial-results/#:~:text=Fourth%2DQuarter%202020%20Worldwide%20Sales,Foreign%20Exchange%2C%20Sales%20Grew%2010%25
  203. https://www.fiercepharma.com/special-reports/top-20-pharma-companies-2021-revenue#:~:text=Darzalex%20revenues%20jumped%2044%25%20last,with%20$2.4%20billion%20in%20sales.
  204. https://www.biospace.com/merck-s-bridion-could-face-generic-pressure-from-hikma-ahead-of-patent-expiry-date#:~:text=Bridion%20is%20a%20modified%20gamma,patients%20with%20unmet%20medical%20needs.
  205. https://www.biospace.com/merck-s-bridion-could-face-generic-pressure-from-hikma-ahead-of-patent-expiry-date#:~:text=Bridion%20is%20a%20modified%20gamma,patients%20with%20unmet%20medical%20needs.
  206. https://www.biospace.com/merck-s-bridion-could-face-generic-pressure-from-hikma-ahead-of-patent-expiry-date#:~:text=The%20drug%20is%20one%20of,according%20to%20the%20SEC%20filing.
  207. https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2023-financial-results/#:~:text=Pharmaceutical%20sales%20growth%20was%20primarily%20driven%20by,acute%20care%20products%2C%20including%20PREVYMIS%20and%20BRIDION.
  208. https://www.biospace.com/merck-s-bridion-could-face-generic-pressure-from-hikma-ahead-of-patent-expiry-date#:~:text=The%20drug%20is%20one%20of,according%20to%20the%20SEC%20filing.
  209. https://www.centerforbiosimilars.com/view/global-biosimilars-market-sees-gains-in-access-and-pipeline-expansion
  210. https://ehealth.eletsonline.com/2025/12/from-22-billion-to-90-billion-us-biosimilars-surge-fuels-strategic-pivot-in-indian-pharma/
  211. https://www.marketsandmarkets.com/Market-Reports/biosimilars-40.html
  212. https://finance.yahoo.com/news/biosimilars-market-outlook-report-2026-163100325.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAGGhQiS7fpLq0NWbCHu4DUpvkVwr3EiM97tldS5nZ0XKo3Dd5k7G8Mvik-FHN2kp7Iz4hsxDIsiQSU5IX7olMpxS7gleTbeiDsj3Osk7ahtBjPiWwBEuyA9pKna1NKSkexQwfCD2AphUL-tQ_43E8NxVHlzctpgqQ1I9Up_bjjUj
  213. https://www.coherentmarketinsights.com/press-release/biosimilars-market-to-surpass-us-70-billion-by-2026-666
  214. https://www.bigmoleculewatch.com/2025/12/12/european-biosimilar-updates-six-denosumab-launches-and-positive-opinion-for-samsung-bioepiss-byooviz/
  215. https://www.pearceip.law/2025/12/13/biocon-secures-uk-eu-row-settlement-with-regeneron-bayer-for-biosimilar-aflibercept-uk-launch-in-jan-2026/
  216. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
  217. https://www.ema.europa.eu/en/documents/report/human-medicines-2025_en.pdf
  218. https://pharmacydaily.com.au/news/ema-recommends-record-41-biosimilars/118428#:~:text=THE%20European%20Medicines%20Agency%20(EMA,had%20a%20new%20active%20substance.
  219. https://www.rheumatologyadvisor.com/news/fda-drug-approval-decisions-expected-in-january-2026/#:~:text=EBV+%20PTLD%20is%20a%20rare,at%20risk%20for%20disease%20progression.
  220. https://www.genengnews.com/topics/drug-discovery/top-15-best-selling-drugs-launched-in-2020/#:~:text=Table_title:%20Top%2015%20Best%2DSelling%20Drugs%20Launched%20in,Ayvakit%20%E2%84%A2%20(avapritinib):%20Nurtec%E2%84%A2%20ODT%20(rimegepant)%20%7C
  221. https://www.amjmed.com/article/S0002-9343(21)00276-X/abstract#:~:text=aDepartment%20of%20Clinical%20Sciences%2C%20High,Florida%20College%20of%20Pharmacy%2C%20Gainesville.&text=In%202020%2C%20the%20US%20Food%20and%20Drug%20Administration%20(FDA),are%20summarized%20in%20Table%201.&text=(selumetnib%2C%20AstraZeneca%20%5BCambridge%2C,of%20different%20types%20of%20cancers.&text=with%20hospitals%20and%20other%20healthcare,drugs%20to%20their%20prescribing%20formularies.
  222. https://www.binasss.sa.cr/set21/5.pdf
  223. https://www.nature.com/articles/d41573-021-00002-0#:~:text=Table_title:%20Table%201%20%7C%20CDER%20approvals%20in,Sponsor:%20Sanofi%20%7C%20Indication:%20Multiple%20myeloma%20%7C
  224. https://www.sciencedirect.com/science/article/pii/S0223523421001331#:~:text=Highlights,and%20Drug%20Administration%20during%202020.
  225. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2021#:~:text=What%20are%20%22Novel%22%20Drugs?,Biologics%20License%20Applications%20(BLAs).
  226. https://www.amjmed.com/article/S0002-9343(22)00146-2/fulltext#:~:text=Abstract,by%20the%20FDA%20in%202021.
  227. https://www.sciencedirect.com/science/article/pii/S0223523422008005#:~:text=Introduction,6%5D%2C%20%5B7%5D%5D.
  228. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2022#:~:text=What%20are%20%22Novel%22%20Drugs?,type%20of%20non%2DHodgkin%20lymphoma
  229. https://link.springer.com/article/10.1186/s43556-023-00138-y#:~:text=Introduction,%25%20of%20all%20approved%20drugs).
  230. https://pubmed.ncbi.nlm.nih.gov/36889492/#:~:text=Abstract,;%20Novel%20drugs;%20Priority%20review.
  231. https://www.fda.gov/drugs/novel-drug-approvals-fda/new-drug-therapy-approvals-2022#:~:text=Innovation%20Across%20Medical%20Conditions,diseases%20and%20conditions%20such%20as:
  232. https://pubmed.ncbi.nlm.nih.gov/37661221/#:~:text=Abstract,effective%2C%20and%20practical%20synthetic%20techniques.
  233. https://www.sciencedirect.com/science/article/pii/S1359644624000916#:~:text=Annual%20approval%20numbers,Orange%20and%20Purple%20books%2C%20respectively.
  234. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2023#:~:text=What%20are%20%22Novel%22%20Drugs?,Drug%20Therapy%20Approvals%20for%202023.
  235. https://www.fda.gov/news-events/fda-voices/fda-approves-many-new-drugs-2023-will-benefit-patients-and-consumers#:~:text=In%202023%2C%20CDER%20approved%2055,not%20been%20previously%20FDA%2Dapproved.
  236. https://pmc.ncbi.nlm.nih.gov/articles/PMC11074039/#:~:text=The%20US%20Food%20and%20Drug%20Administration%20(FDA)%20approved%2037%20new,discussed%20according%20to%20therapeutic%20areas.
  237. https://pmc.ncbi.nlm.nih.gov/articles/PMC11074039/#:~:text=The%20US%20Food%20and%20Drug%20Administration%20(FDA)%20approved%2037%20new,discussed%20according%20to%20therapeutic%20areas.
  238. https://www.sciencedirect.com/science/article/pii/S0223523425000066
  239. https://www.mdpi.com/1420-3049/30/3/482#:~:text=During%202024%2C%20the%20U.S.%20Food,confidence%20in%20the%20pharmaceutical%20sector.
  240. https://www.nature.com/articles/d41573-025-00001-5#:~:text=The%20FDA%20approved%2050%20new,1;%20Table%201).
  241. https://www.fda.gov/files/drugs/published/new-drug-therapy-2025-annual-report.pdf#:~:text=In%202024%2C%20CDER%20approved%2050%20novel%20drugs%2C,therapeutic%20biologics%20under%20Biologics%20License%20Applications%20(BLAs).
  242. https://www.nature.com/articles/d41573-026-00001-z#:~:text=The%20US%20FDA%20approved%2046,drugs%20per%20year%20since%201993.
  243. https://www.fiercepharma.com/pharma/2025-drug-approvals#:~:text=Of%20the%20FDA's%2046%20novel,drugs%20were%20for%20orphan%20diseases.
  244. https://cen.acs.org/pharmaceuticals/FDAs-new-drug-approvals-dipped/104/web/2026/01#:~:text=The%20year%202025%20saw%2046,20%25%20of%20the%202025%20approvals.
  245. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025#:~:text=What%20are%20%22Novel%22%20Drugs?,novel%20drugs%20approvals%20for%202025.
  246. https://finance.yahoo.com/news/semaglutide-market-size-reach-usd-120000764.html
  247. https://www.sec.gov/Archives/edgar/data/310158/000031015825000059/mrk-20250930.htm

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