Keytruda: USFDA accepts biosimilar application of Zydus and German firm for Keytruda | India News

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<button type="button" class="ZW6JD " disabled="">Post Comment</button></p> <p class="swnca">Be respectful · <a href="https://www.indiatimes.com/termsandcondition" target="_blank" rel="noopener noreferrer" class="gkv0P">TOI community guidelines</a></p> </div> </div> <p><span class="id-r-component br" data-pos="18"/>Formycon holds the global rights to FYB206 and will participate in the gross profits of its commercialization partners.<span class="id-r-component br" data-pos="21"/>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, the statement adds.</div> </div> <br /><a href="https://timesofindia.indiatimes.com/india/usfda-accepts-biosmilar-application-of-zydus-and-german-firm-for-keytruda/articleshow/134922599.cms">Source link </a></p> </div><!-- .entry-content /--> <div id="post-extra-info"> <div class="theiaStickySidebar"> <div class="single-post-meta post-meta 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</span></span><span class="date meta-item tie-icon">3 hours ago</span><div class="tie-alignright"><span class="meta-comment tie-icon meta-item fa-before">0</span><span class="meta-views meta-item "><span class="tie-icon-fire" aria-hidden="true"></span> 0 </span><span class="meta-reading-time meta-item"><span class="tie-icon-bookmark" aria-hidden="true"></span> 1 minute read</span> </div></div><!-- .post-meta --> <div id="share-buttons-top" class="share-buttons share-buttons-top"> <div class="share-links icons-only share-rounded"> <a href="https://www.facebook.com/sharer.php?u=https://newsnation.aanest.com/?p=38287" rel="external noopener nofollow" title="Facebook" target="_blank" class="facebook-share-btn " data-raw="https://www.facebook.com/sharer.php?u={post_link}"> <span class="share-btn-icon tie-icon-facebook"></span> <span class="screen-reader-text">Facebook</span> </a> <a href="https://x.com/intent/post?text=Keytruda%3A%20USFDA%20accepts%20biosimilar%20application%20of%20Zydus%20and%20German%20firm%20for%20Keytruda%20%7C%20India%20News&url=https://newsnation.aanest.com/?p=38287" rel="external noopener nofollow" title="X" target="_blank" class="twitter-share-btn " data-raw="https://x.com/intent/post?text={post_title}&url={post_link}"> <span class="share-btn-icon tie-icon-twitter"></span> <span class="screen-reader-text">X</span> </a> <a href="https://api.whatsapp.com/send?text=Keytruda%3A%20USFDA%20accepts%20biosimilar%20application%20of%20Zydus%20and%20German%20firm%20for%20Keytruda%20%7C%20India%20News%20https://newsnation.aanest.com/?p=38287" rel="external noopener nofollow" title="WhatsApp" target="_blank" class="whatsapp-share-btn " data-raw="https://api.whatsapp.com/send?text={post_title}%20{post_link}"> <span class="share-btn-icon tie-icon-whatsapp"></span> <span class="screen-reader-text">WhatsApp</span> </a> <a href="#" rel="external noopener nofollow" title="Print" target="_blank" class="print-share-btn " data-raw="#"> <span class="share-btn-icon tie-icon-print"></span> <span class="screen-reader-text">Print</span> </a> </div><!-- .share-links /--> </div><!-- .share-buttons /--> </div> </div> <div class="clearfix"></div> <script id="tie-schema-json" type="application/ld+json">{"@context":"http:\/\/schema.org","@type":"Article","dateCreated":"2026-10-13T22:27:09+05:30","datePublished":"2026-10-13T22:27:09+05:30","dateModified":"2026-10-13T22:27:09+05:30","headline":"Keytruda: USFDA accepts biosimilar application of Zydus and German firm for Keytruda | India News","name":"Keytruda: USFDA accepts biosimilar application of Zydus and German firm for Keytruda | India News","keywords":[],"url":"https:\/\/newsnation.aanest.com\/keytruda-usfda-accepts-biosimilar-application-of-zydus-and-german-firm-for-keytruda-india-news\/","description":"NEW DELHI: 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","copyrightYear":"2026","articleSection":"India","articleBody":"\r\n NEW DELHI: 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\u2019s Keytruda (pembrolizumab), a key cancer drug. Keytruda is the world\u2019s best-selling biologic medicine with global sales at $16.4 billion for the first half this year, and over $31 billion in 2025.This could be the first publicly announced acceptance by the USFDA of the application for a Keytruda biosimilar, FYB206, according to the company.The BLA was submitted in the third quarter of 2026.Under the Biosimilar User Fee Amendments, the USFDA aims to complete its review within twelve months of submission, comprising up to 60 days for the filing review and 10 months for the substantive review. A decision could be expected in the third quarter of 2027.The regulatory dossier for FYB206 has also been submitted to Health Canada.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, while Zydus holds exclusive commercialization rights for the US and Canada.Share your thoughts in the commentsInsightfulAgreeDisagreeSkepticalConcerningPromisingWorth ReadingBig DevelopmentPost CommentBe respectful \u00b7 TOI community guidelinesFormycon holds the global rights to FYB206 and will participate in the gross profits of its commercialization partners.With the USFDA\u2019s acceptance of the BLA for review, Formycon has reached a regulatory milestone under the agreement that entitles it to a milestone payment from Zydus, the statement adds.\r\n\r\nSource link ","publisher":{"@id":"#Publisher","@type":"Organization","name":"news 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