Biocon Says U.S. FDA Proposal Could Cut Biosimilar Costs by 50%

BENGALURU — Indian biopharmaceutical firm Biocon Ltd. expects the cost of developing new biosimilars to fall by about half following a U.S. proposal to ease clinical testing rules, according to Shreehas Tambe, chief executive of Biocon Biologics, the company’s biologics division.

The U.S. Food and Drug Administration (FDA) released draft guidance last month that would limit the need for large-scale efficacy trials in biosimilar approvals.
The proposal favors advanced laboratory analytics and smaller safety studies over full comparative trials, a change that could reduce both time and spending in development.

Lower Testing Could Halve Development Expenses

Biosimilars are near-identical versions of high-cost biological drugs used in treating cancer, diabetes, and autoimmune diseases.
Their development is far more complex than that of conventional generics, often taking nearly a decade and requiring hundreds of patients for trial enrollment.

Tambe said the FDA’s proposal could lower those costs by around 50%.

“It will allow us to bring products to market faster, at a lower cost, while maintaining scientific rigor,” he said.

He added that the savings could be reinvested into additional pipeline programs, particularly in oncology and immunology.

Biocon Plans Two More U.S. Biosimilar Launches

Biocon Biologics, the biosimilar arm of Biocon Ltd., has seven biosimilars already approved in the United States and is preparing to introduce two additional products within the next six months, CEO Shreehas Tambe said.

The company is prioritizing filings in oncology and autoimmune treatments, areas where several branded biologics are losing patent protection.
Tambe said Biocon’s existing cancer biosimilars account for about one-fourth of the U.S. market in their respective categories, giving it a strong base for new entries.

He added that the FDA’s proposed trial reforms would allow Biocon to submit the same clinical data to both U.S. and European regulators, cutting duplicate studies and reducing time to approval for upcoming drugs.

Biosimilars Account for Bulk of Revenue

More than 60% of Biocon’s total revenue now comes from biosimilars, and the segment’s sales grew 25% year-on-yearin the most recent quarter.
The company has invested heavily in regulatory filings, analytical testing, and capacity expansion at its manufacturing facilities in Bengaluru and Malaysia.

Tambe said the lower-cost pathway could allow Biocon to double the number of concurrent biosimilar programs without increasing total R&D spending.

Plans to Add New Therapeutic Lines

Alongside biosimilars, Biocon is building a broader generics pipeline.
The company has identified metabolic disorders and weight-management drugs as its next major growth areas.
Executives said existing manufacturing capacity and distribution partnerships can support both biologics and small-molecule launches without significant new investment.

FDA Proposal Could Simplify Global Biosimilar Approvals

The United States generates most of Biocon’s biosimilar revenue, followed by Europe and Japan.
Biocon executives said the FDA’s new trial guidance will likely become the reference model for future filings in markets that already rely on U.S. data, such as the U.K. and several European Union countries.

The company’s regulatory teams have started adjusting their documentation and lab protocols to match the FDA’s new analytical standards.
Biocon plans to file three new biosimilars for review in both the U.S. and Europe within the next 18 months, using the same data package instead of repeating separate trials in each region.

According to the company, aligning submissions across regulators will reduce duplicate studies and speed up approvals for new products already in late-stage development.

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