News

Zydus Lifesciences moves closer to US launch of key cancer drug biosimilarZydus Lifesciences’ in-licensed pembrolizumab biosimilar met the primary endpoint in a pivotal PK study, paving the way for a near-term USFDA filing and entry into the North American market.By CNBCTV18.com February 27, 2026, 3:50:50 PM IST (Published)2 Min Read(Photo Credit : CNBC-TV18 Library )Zydus Lifesciences Ltdon Friday, February 27, said its in-licensed pembrolizumab biosimilar has met the primary endpoint in a pivotal pharmacokinetic (PK) study, paving the way for a planned filing with the US Food and Drug Administration (USFDA).

The randomised, double-blind, multi-centre study demonstrated pharmacokinetic equivalence between FYB206 and Keytruda (pembrolizumab), an immuno-oncology therapy. Zydus has in-licensed the product from Formycon AG for the US and Canadian markets, the company said in a regulatory filing.

The companies had agreed with the USFDA in early 2025 on a streamlined clinical strategy to establish therapeutic comparability with the reference drug, based on analytical data and results from the Dahlia PK study. With the primary objective achieved, the focus now shifts to completing development activities and preparing regulatory submissions.

Zydus said the data package supports a near-term Biologics License Application (BLA) filing in the US, potentially positioning it among the early applicants in the North American pembrolizumab biosimilar segment.

Pembrolizumab is a humanised monoclonal antibody and immune checkpoint inhibitor used to treat multiple cancers. The reference drug, marketed as Keytruda, reported global sales of $31.6 billion in 2025, making it one of the world’s best-selling medicines.

Also Read: Lupin gets Establishment Inspection Report from the USFDA for its Goa facility

FYB206 is expected to be launched after expiry of exclusivity of the reference product, subject to regulatory approval.

Earlier this month, the company reported a strong performance for the quarter ended December 31, 2025. Net profit rose to ₹1,042 crore, beating Street estimates of ₹940 crore and marking a 2% year-on-year increase.

Revenue climbed 30.3% to ₹6,865 crore from ₹5,269 crore in the year-ago period.

Shares of the company settled at ₹922.90 apiece, down 1.66% for the day.Continue Reading(Edited by : Sheersh Kapoor)Tagsshare market todayZydus Lifesciences