Biocon CEO sees USFDA draft rules potentially slashing biosimilar development costs by half

Biocon

Biocon expects the US President Donald Trump administration’s proposed draft guidelines on biosimilars to cut development costs by nearly 50%, a move that could reshape the economics of biologics for the Indian drugmaker.

Global biosimilar development typically costs between $100 million and $200 million, but the U.S. Food and Drug Administration’s updated recommendations aim to eliminate expensive comparative efficacy studies, relying instead on advanced analytical and pharmacokinetic data.

“This is a game-changer,” said Sidharth Mittal, Biocon’s Managing Director and CEO, in an interview to Moneycontrol. “If comparative clinical trials are no longer mandatory, we can halve development costs and accelerate market entry. It’s a huge boost for companies like us targeting the U.S., the largest biosimilars market.”

Mittal cautioned that not all biosimilars may not qualify for these exemptions, but many would.

The USFDA’s draft guidance reflects growing confidence in analytical technologies to demonstrate bio-similarity without full-scale efficacy trials, which have historically been the costliest component of development.

Mittal added that Biocon also expects biosimilars to be treated like generics in trade policy, exempting them from tariffs that have disrupted pharmaceutical supply chains.

“Given their role in reducing healthcare costs, we believe biosimilars will be excluded from any tariff regime,” he said.

Biocon, which has built a global footprint in biologics, is betting big on the U.S. market with new launches and pipeline of high-value launches.

The company plans to roll out insulin aspart in the coming quarters. The company is looking to capitalize on the interchangeable status and growing demand for rapid-acting insulin alternatives. The deal with non-profit generic company Civica for insulin glargine lays groundwork for broader distribution via private‑label frameworks.

The company launched monoclonal antibody biosimilars such as adalimumab, bevacizumab and denosumab, targeting chronic conditions like cancer, autoimmune disorders and osteoporosis. Biocon has USFDA approvals for aflibercept, which it plans to launch in coming comping quarters.

These launches are expected to strengthen Biocon’s position in a market where biologics dominate spending and payers are pushing for cost-effective alternatives.