Biosimilars
Biosimilars are safe and effective treatment options for various illnesses, including chronic skin and bowel diseases (such as psoriasis, irritable bowel syndrome, Crohn’s disease, and colitis), arthritis, kidney conditions, and cancer. These medicines are very close in structure and function to biologic medicines and increase access to lifesaving medications at potentially lower costs. They are highly similar to a biologic medication already approved by a regulatory body – the original biologic (also called the reference product).
Both a biosimilar and its original biologic:
• Are made from the same types of sources (e.g. living sources)
• Provide the same benefits when treating diseases or medical conditions
• Are provided at the same strength and dosage • Are not expected to cause new or worsening side effect
Biosimilars versus generics
Biosimilars and Generics are alternate versions of medications that are already approved by a regulatory body, but these two types of medicines show some significant differences:
Advantages of biosimilars:
- Biosimilars provide a lower-cost option to replace original-brand products
• Improve access to patients when compared to the reference biologics
• Provide more treatment options for patients with serious and life-threatening diseases
• Similarly effective as the reference biological medicines
Global distribution of biosimilars approvals (7 years)
In recent years, biosimilars have gained significant attention and importance in healthcare, particularly in the United States and Europe. These biological products, which are highly similar to reference biologic medicines, offer increased access to cost-effective treatments and can potentially lower healthcare expenditures
2025 marked a surge in biosimilar approvals across both the U.S. and Europe, driven by a wave of blockbuster biologic drugs — including high-revenue products in oncology, immunology, and ophthalmology — that lost patent protection around 2023–2025. This created large opportunities for biosimilar developers to seek approval for alternatives, significantly expanding the candidate pool. In Europe, the EMA recommended around 41 biosimilars for approval—the highest ever in a single year—spanning oncology, autoimmune diseases, osteoporosis, and ophthalmology.
In the U.S., a similar dynamic played out as several high-cost biologics came off patent, enabling multiple developers to advance biosimilar filings in parallel. By year-end 2024, dozens of biosimilar programs reached the approval stage, underscoring growing investment and confidence from both global biosimilar players and large pharma.
Biosimilars approved in 7 years
Fig 3: Yearly trend of biosimilars approved from 2019-H12025 in US and EU