Home / Business and Economy / Biocon Cuts Biosimilar Costs by 50% as US Eases Testing Rules
Biocon Cuts Biosimilar Costs by 50% as US Eases Testing Rules
13 Nov
Summary
- Biocon expects 50% drop in biosimilar development costs
- US FDA proposes to simplify drug testing for biosimilars
- Biocon aims to launch 20 biosimilars by 2030
As of November 13, 2025, the Indian pharmaceutical firm Biocon is poised to benefit significantly from the US FDA's proposal to simplify drug testing for biosimilars. Biosimilars are copies of costlier biological drugs used to treat major illnesses, and they make up more than 60% of Biocon's revenue.
The FDA's draft proposal to lower the requirement for large comparative clinical efficacy trials is expected to halve the cost of developing biosimilars, according to Shreehas Tambe, CEO of Biocon Biologics. This will allow Biocon to "develop them and bring them to patients faster and make it more affordable." The company, which already has seven biosimilars in the US market, is looking to launch two more in the next six months.
Biocon's oncology biosimilar medicines currently hold a 25% market share in the US, and the lower development costs will further boost their affordability and accessibility. Additionally, the firm's revenue from biosimilars grew 25% in the latest quarter, indicating strong momentum in this segment. Biocon is also expanding its generics business with the launch of weight-loss drugs to drive future growth.
