FDA accepted the BLA for Zydus’s proposed Keytruda biosimilar, a first publicly announced approval for a pembrolizumab biosimilar, and said the review should conclude within 12 months, with a decision expected in the third quarter of 2027—according to the company’s filing on Tuesday.
The U.S. Food and Drug Administration inspected Zydus’s Moraiya, Ahmedabad plant from Oct 5 to Oct 13, 2026, issuing five observations that the firm plans to address immediately, said a company spokesperson.
Bernstein’s research team reiterated its buy rating, citing the FDA acceptance as a “crucial validation of Zydus’s biologics strategy.” The firm’s target price of ₹1,457 implies a 29% upside from the current ₹1,132.5 close and is based on a projected $500 million gross end‑market sales estimate and 60% product margin.
In the broader biopharma landscape, the company’s 34 analyst covers show 19 buy, nine hold, and six sell recommendations, reflecting cautious optimism. Zydus’s stock has gained 15.7% YTD, a 3.1% rise in the past month, amid a sector that saw 12% higher average gains in the last quarter.
Looking ahead, the company expects to submit a substantive response to the FDA’s observations by Q2 2027. If the biosimilar clears review, Zydus could capture an estimated $7–8 billion IV market in the first year post‑exclusivity, with Formycon receiving half the territory profit. The next major event will be the FDA decision in Q3 2027, after which the market will reassess the 29% upside forecast.