The global biosimilars market is projected to grow to $ 73.03 billion by 2030, registering a CAGR of 17.3% per cent in the last 7 years. The market was valued at $ 35.05 billion in 2025, $ 23.96 in 2023 and $ 20.44 billion in 2022, according to a report from Fortune Business Insights on December 29, 2025.

Regulatory authorities in developed countries are now approving biosimilars at a fast rate due to availability of more precise guidelines. US has approved an estimated 85 biosimilars by the end of 2025, compared to 45 in 2023. Europe has approved more than 86 biosimilars in the last decade.

Notable approvals by US FDA in 2025 include:

• Denosumab: Several biosimilars (e.g., Osenvelt, Stoboclo, Ospomyv, Xbryk, Bomyntra, Conexxence, Osvyrti, Jubereq) for Prolia/Xgeva were approved, with many receiving interchangeability designations.
• Tocilizumab: Celltrion's Avtozma (tocilizumab-anoh) was approved for Actemra.
• Omalizumab: Sanofi's Omlyclo was approved for Xolair.
• Ustekinumab: Alvotech's Selarsdi and Sandoz's Enzeevu were approved for Stelara, with some provisional interchangeability.
• Pertuzumab: Poherdy (pertuzumab-dpzb) was approved in November 2025 for Perjeta. 

Regulators, such as the European Medicine Agency (EMA), the U.S. Food and Drug Administration (FDA), and Health Canada (HC) have developed stringent regulatory guidelines for the assessment and approval of these products in terms of their physical characteristics, chemical composition, and clinical characteristics. This has enabled rapid drug development and approval, as well as increased market access and cost-effectiveness

A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.