Zydus moves closer to US market for Keytruda biosimilar as FDA accepts
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Zydus Lifesciences has received acceptance for its application regarding the biosimilar of Keytruda, which is a major cancer drug. The USFDA is expected to complete its review process by the third quarter of 2027. This biosimilar, named FYB206, was developed without a comparative Phase III efficacy trial. Zydus aims to make effective treatments more accessible in the oncology field in North America.
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Loading...×MUMBAI: The US Food and Drug Administration has accepted Zydus Lifesciences’ application for review of the world’s first publicly announced biosimilar of cancer drug Keytruda (pembrolizumab), one of the highest-grossing medicines that makes innovator Merck (MSD in India) over $30 billion a year.The proposed biosimilar FYB206, if approved, could potentially make the Ahmedabad-based company one of the first to gain access to the US market for pembrolizumab, which is recommended in over 40 FDA-approved indications in about 19 cancer types, including skin, lung, breast and colon cancer.
Zydus holds exclusive commercialisation rights for the US and Canada and brings extensive commercial experience in the North American market for this product.
“Acceptance of the application marks a significant step toward expanding access to affordable pembrolizumab therapy in the US and Canada,” said Sharvil P Patel, managing director of Zydus Lifesciences.
Zydus is developing FYB206 jointly with Formycon AG, a Munich-based independent developer of biosimilars.
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The drug will now undergo a full regulatory evaluation, and the FDA review decision is expected by the third quarter of 2027, Zydus said on Tuesday.
“The Biologics License Application (BLA) was submitted in the third quarter of 2026… The regulatory dossier for FYB206 has also been submitted to Health Canada,” it said in a statement.
Historically, FDA approval rate of biosimilars accepted for review exceeds 90%, according to biopharmaceutical intelligence platform DrugPatentWatch.
Keytruda (pembrolizumab) is an immune checkpoint inhibitor that binds to and blocks the PD-1 receptor.
In 2025, its worldwide sales, including the subcutaneous formulation Keytruda Qlex, reached $31.7 billion. In the first half of 2026, combined sales of Keytruda and Keytruda Qlex totalled $16.40 billion, which maintains Keytruda’s position as the world’s best-selling biologic medicine.
Doctors said a Keytruda biosimilar will bring significant benefit to patients.
“Keytruda has broad spectrum indication and has significant benefit in progression free survival,” said Sunil Chopade, medical and haemato-oncologist at Mumbai’s Jaslok Hospital. “Biosimilars will increase access to the drug by significantly bringing down cost.”
Patil recently told ET: “The opportunity (in cancer drugs) is not just about bringing products to market. It is about making these therapies accessible to patients and building capabilities that allow us to participate in the next generation of cancer treatment.”
Analysts said it is too early to assess the impact of the development on Zydus as it depends on the actual patent expiry of the product.
While Merck’s original patents for Keytruda are set to expire in 2028, the company is said to have filed multiple additional patents that may protect the product a year or two more, analysts said.
“The timeline of Keytruda’s patent expiry is around FY31 and in the build-up to that, one has to see the competition landscape,” said Soorya N Patra, a pharma analyst at Phillip Capital.
Vishal Manchanda, pharma analyst at Systematix Group, said while the pembrolizumab biosimilar opportunity is large and the first mover advantage could help, it doesn’t guarantee success. “Merck is preparing well, and their intention is to effectively compete with biosimilars,” he said.
On Tuesday, Zydus shares ended 0.7% down at Rs 1,131 on the BSE.
A large set of global companies are expected to compete for the pembrolizumab market.
In September, Cipla’s US subsidiary Invagen partnered with Chinese biotech Qilu for an exclusive licensing and supply partnership for the drug while others like Biocon and Sandoz are also seen as first-wave launch contenders when the core patent of pembrolizumab expires.
FYB206 was developed without a comparative Phase III efficacy trial, following a development pathway agreed upon with the USFDA in early 2025, according to Stefan Glombitza, CEO of Formycon AG. “This enabled us to accelerate the program and substantially reduce development investment while maintaining the rigorous scientific standards required for biosimilar approval,” he added.
In December 2025, Formycon and Zydus had entered into an exclusive licensing and supply agreement for FYB206 in the US and Canada. Formycon is responsible for completing development, preparing and filing the regulatory dossiers, and supplying the product.
With the USFDA’s acceptance of the BLA for review, Formycon has reached a regulatory milestone under the agreement that entitles it to a milestone payment from Zydus.
Zydus will commercialise FYB206 in both markets, subject to regulatory approval and resolution of any intellectual property issues. Formycon holds the global rights to FYB206 and will participate in the gross profits of its commercialization partners.
Oncology is one of the areas where Zydus has been investing for a long time, building across oral oncology as well as biologics and newer-generation therapies.
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( Originally published on Oct 13, 2026 )Read More News onzydus lifesciencesZydus LifesciencesKeytruda biosimilarFDA application acceptancecancer treatmentFYB206oncology biosimilarsbiologics marketHealth CanadaFormycon AG
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Read More News onzydus lifesciencesZydus LifesciencesKeytruda biosimilarFDA application acceptancecancer treatmentFYB206oncology biosimilarsbiologics marketHealth CanadaFormycon AG
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Figures reflect the source report and its stated period. This article is for information and is not investment advice.
