India's Biocon Foresees Big Cost Drop for Copycat Drugs
By Reuters | 13 Nov, 2025

A leading maker of biosimilars, with 7 copycat drugs already in the US market, sees a 50% drop in development cost for drugs mimicking costlier drugs for cancer, arthritis and diabetes due to the FDA's proposal to relax drug testing requirements.

India's Biocon expects a 50% drop in costs for developing complex biosimilars as the United States has proposed to ease clinical testing for the drugs that make up more than 60% of its revenue, a top executive said on Wednesday.

Biosimilars are copies of costlier biological drugs used to treat major illnesses such as cancer, rheumatoid arthritis, psoriasis and diabetes. The U.S. Food and Drug Administration last month proposed to simplify drug testing by lowering the requirement for large comparative clinical efficacy trials. 

Biocon, which aims to cumulatively launch 20 biosimilars by 2030, is focusing on upcoming launches in the key markets of U.S. and Europe, Shreehas Tambe, CEO of Biocon Biologics, a unit of Biocon, said in an interview.

"You can do more because it's (FDA's draft proposal) going to halve the cost of development ... you can develop them (biosimilars) and bring them to patients faster and make it more affordable." 

Biocon, which has seven of its biosimilars in the commercial market in the U.S., is looking to launch two more in the next six months. The company's oncology biosimilar medicines have a fourth of the U.S. market share and will benefit from the lower development cost, Tambe said.

The firm's revenue from biosimilars grew 25% in the latest quarter. 

Biocon is also looking to expand its generics segment with the launch of weight-loss drugs to drive future growth, the company had said earlier. 

(Reporting by Rishika Sadam; Editing by Harikrishnan Nair)