Zydus Lifesciences Share Price in Focus After FYB206 Application Gets USFDA Review Acceptance

Zydus Lifesciences and Formycon AG announced on October 13, 2026, that the US Food and Drug Administration (USFDA) had accepted the application for FYB206 for review.  

FYB206 is a proposed biosimilar to Keytruda (pembrolizumab), a drug used to treat several types of cancer. The companies noted that FYB206 was the first publicly announced Keytruda biosimilar candidate to have its application accepted for review by the US regulator.  

The application was filed in the third quarter of 2026. Acceptance for review does not mean the drug has been approved for sale. 

Decision Expected in 2027 

The USFDA aims to complete its review within 12 months of submission under the Biosimilar User Fee Amendments. The process includes up to 60 days for the initial filing review and 10 months for the main review. 

Based on this timeline, a decision on FYB206 could be expected in the third quarter of 2027. The regulatory dossier has also been submitted to Health Canada. 

Formycon developed FYB206 without a comparative Phase III efficacy trial. The company had agreed on this development approach with the USFDA in February 2025. 

Agreement Covers US and Canadian Markets 

Zydus and Formycon signed an exclusive licensing and supply agreement for FYB206 in December 2025. Formycon is responsible for completing development, preparing regulatory filings and supplying the product. 

Zydus holds exclusive commercialisation rights in the United States and Canada. Acceptance of the application triggers a milestone payment to Formycon under the agreement.  

Sales in both markets will depend on regulatory approval and the resolution of any intellectual property issues. 

Keytruda Sales 

Keytruda is an immune checkpoint inhibitor that blocks the PD-1 receptor. Worldwide sales of Keytruda, including its subcutaneous formulation Keytruda Qlex, reached US$31.7 billion in 2025.  

Combined sales stood at US$16.40 billion in the first half of 2026. 

Read More: Polycab Share Price in Focus as NSE Announces Exclusion from Equity Derivatives Segment from December 30, 2026! 

Zydus Lifesciences Share Price Performance  

As of October 13, 2026, 11:15 am, Zydus Lifesciences share price was trading at ₹1,133.00, a 0.12% decrease from the previous closing price. 

Conclusion 

FYB206 remains under regulatory review and has not been approved in any country. The USFDA decision could come in the third quarter of 2027, based on the stated review timeline. 

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