USFDA accepts the first publicly announced Keytruda biosimilar for review; Zydus holds the US and Canada rights

At 09:50 IST on Tuesday, October 13, Zydus Lifesciences filed a joint press release with Germany's Formycon AG: the US Food and Drug Administration has accepted for review the Biologics License Application for FYB206, a proposed biosimilar to Keytruda (pembrolizumab). To the best of the two companies' knowledge, this is the first publicly announced acceptance by the USFDA of an application for a Keytruda biosimilar. Keytruda is the world's best-selling biologic medicine — worldwide sales, including the subcutaneous Keytruda Qlex, reached USD 31.7 billion in 2025 and USD 16.40 billion in the first half of 2026, per Merck's own disclosures cited in the release. Zydus holds exclusive commercialization rights for the United States and Canada.

The structure of the partnership is laid out in the release. In December 2025, Formycon and Zydus entered an exclusive licensing and supply agreement for FYB206 covering the United States and Canada. Formycon is responsible for completing development, preparing and filing the regulatory dossiers, and supplying the product; it holds the global rights and will participate in the gross profits of its commercialization partners. Zydus will commercialize FYB206 in both markets — subject to regulatory approval and resolution of any intellectual property issues, a qualifier the release carries explicitly. The release's own disclaimer is equally explicit: FYB206 is an investigational product, has not received regulatory approval in any country, and biosimilarity has not been established or claimed.

Formycon's CEO Dr. Stefan Glombitza framed the development pathway as the differentiator: the company developed FYB206 on a path agreed with the FDA without conducting a comparative Phase III efficacy trial, which he said enabled it to accelerate the program and substantially reduce development investment. The release also cites IQVIA Institute data on why this market matters: 118 biologic medicines with sales of USD 232 billion will lose exclusivity in the US alone by 2034, and for only twelve of them is a biosimilar in development. Those are the companies' framing numbers, not independent estimates — but they describe the lane Zydus has bought into: a first-in-queue regulatory position on the biggest biologic of them all.

A first-in-queue position on the world's best-selling biologic, with the decision clock set for the third quarter of 2027.

1. 21 Aug

   Final USFDA approval for Ascorbic Acid Injection (ANDA) with 180-day CGT exclusivity. The stock closed +1.1% that session.

2. 26 Sept

   USFDA inspection of the pharmacovigilance and post-marketing system at the New Jersey office closed with nil observations.

3. 28 Sept

   USFDA cGMP inspection at the SEZ II plant, Ahmedabad (Sep 21–28) closed with one observation, none related to data integrity. Filed after close; next session −1.2%.

4. 5 Oct

   Launch of Riociguat Tablets in the US with MSN Laboratories — the first generic of Adempas. Filed after close; next session +1.8%.

5. 13 Oct

   USFDA accepts the FYB206 BLA for review — today's filing.

The run-up to this filing has been a steady drumbeat of US regulatory traffic, most of it favourable: a competitive-generic-therapy exclusivity in August, a clean pharmacovigilance inspection in September, and a first-to-market generic launch in October. Two less favourable items sit in the same window: the SEZ II manufacturing inspection, which closed with a single observation that the company said it would work with the USFDA to address expeditiously, and a USD 5.9 million settlement its US subsidiary agreed to pay in September to resolve indirect-reseller claims in the generic-pricing antitrust litigation, entered into without any admission of fault. On the pipeline side, Zydus also reported positive topline Phase II(b) results for Saroglitazar Mg in MASH on August 31 — the trial met its primary endpoint of steatohepatitis resolution with no worsening of fibrosis — and presented a post hoc analysis of the Phase 3 EPICS-III trial in PBC at ACG 2026 on October 12.

The stock set its 52-week adjusted high of ₹1,232 on September 29 and has drifted since — the October 13 close of ₹1,136.30 sits 7.8% below that high and 36.0% above the April 2 low of ₹835.5. The filing reached the exchange at 09:50 IST, during the session, and the day closed +0.2% over Monday's ₹1,134.40 — a muted first print for a headline of this size. One plausible reading, and it is a reading rather than a filed fact: with approval gated on a Q3 2027 decision and on the resolution of any intellectual property issues, the market is treating this as a long-dated option rather than near-term earnings.

Q1 FY27 consolidated revenue of ₹8,017 Cr is the highest of the five quarters shown and 22.0% above Q1 FY26's ₹6,573.7 Cr. Net profit moved the other way: ₹990.2 Cr against ₹1,521 Cr a year earlier, with operating margin at 23.8% versus 31.8%. Summing the last four consolidated quarters gives trailing-twelve-month net profit of ₹4,592.7 Cr, which puts the ₹1,13,346 Cr market cap at roughly 24.7× trailing profit. Whatever FYB206 is ultimately worth, it is not in these numbers yet — the release attaches no revenue estimate, and commercialization is conditional on approval.