Biocon gears up for faster second half with US biosimilar launches and regulatory easing

Biocon anticipates a more dynamic second half of fiscal 2027 driven by new biosimilar launches in the US and regulatory improvements, signalling a positive outlook for the company’s biosimilar pipeline.

Biocon expects its business to gather pace in the second half of fiscal 2027, helped by a cluster of recent biosimilar launches in the United States that are now starting to feed through to revenue. Shreehas Tambe, the company’s chief executive and managing director, said at a post-results briefing in Bengaluru that the back half of the year should be “much more exciting” than the first, pointing to five new US product launches, including aflibercept biosimilar Yesafili, the denosumab biosimilars Bosaya and Aukelso, and a generic version of liraglutide.

The optimism follows a June quarter in which consolidated revenue rose 10 per cent from a year earlier to ₹4,336 crore, with management saying the effect of multiple launches should become clearer over the coming quarters. Among the newer products, Yesafili targets the US market for Eylea, an eye injection, which Tambe said is worth about $3 billion. He said early worries about how quickly doctors would adopt a retina-injected biosimilar had eased after earlier entrants gained traction, and added that customer enquiries and orders were already coming in. Biocon also has a temporary competitive advantage under a patent settlement agreement, giving it a head start in commercialisation.

The company’s US momentum is being reinforced by a more accommodating regulatory backdrop. The Food and Drug Administration has moved to streamline biosimilar development, including by reducing some of the clinical testing burden where scientifically justified, a shift that could cut development costs and speed launches. Tambe said Biocon had already received waivers for phase 3 studies in parts of its pipeline, and argued that the change should favour established biosimilar makers with deeper analytical and pharmacokinetic experience over newer entrants.

Biocon is keeping a close watch on profitability as it scales up the portfolio. Tambe said the focus will remain on product mix, operating leverage and cost discipline, while research and development spending is expected to stay at about 7 per cent of revenue. He said external pressures such as tariffs, geopolitics and logistics costs could still affect margins, but the company’s broader strategy remains unchanged.

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