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USFDA accepts biosimilar application of Zydus and German firm for Keytruda

Source: Times of India — India · 3 hr ago
USFDA accepts biosimilar application of Zydus and German firm for Keytruda
Image: Times of India

Summary

The U.S. Food and Drug Administration has accepted for review a biologics license application submitted jointly by Zydus Lifesciences and Formycon AG for a biosimilar version of Merck’s cancer drug Keytruda (pembrolizumab). This move initiates the regulatory evaluation of the proposed alternative to the widely used immunotherapy.

AI-generated summary. Verify important details at the source.

From the original report

Zydus Lifesciences and Formycon AG, an independent developer of biosimilars, jointly announced that the US Food and Drug Administration (USFDA) has accepted for review the biologics license application (BLA) for a proposed biosimilar to Merck’s Keytruda (pembrolizumab), a key cancer drug.

Excerpt from Times of India — India.

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