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US proposal to halve biosimilar development costs for India's Biocon, top exec says
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US proposal to halve biosimilar development costs for India's Biocon, top exec says
Nov 13, 2025 12:34 AM

By Rishika Sadam

Nov 13 (Reuters) -

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.

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