Biocon: Three-month US FDA trastuzumab biosimilar delay not related to cGMP issues
Biocon and Mylan have teamed up to develop and manufacture a number of biosimilar products in Europe, including a version of Roche’s breast cancer drug Herceptin (trastuzumab) which was submitted to the US Food and Drug Administration (FDA) for review in November last year.
But in a statement sent to the Bombay Stock Exchange, Biocon said: “The US FDA has notified our partner Mylan that they will extend the target action date for their Trastuzumab 351(k) application to Dec 3, 2017 in order to review some of the clarificatory information submitted to them as a part of the application review process.”
The announcement comes following a turbulent few months for Biocon, which manufactures the biosimilar products from its facility in Banglaore, India in accordance with the joint venture.
An inspection in March by France’s regulatory body ANSM (Agence Nationale de Sécurité du Médicament) resulted in a statement of non-compliance with GMP being issued to the firm in July, citing 35 issues at the facility. And last month the FDA issues Biocon with a Form 483 with ten deviations after an inspection in May and June.
However, in a statement sent to Biopharma-Reporter, Biocon said the FDA’s extension of the target action date for trastuzumab “is linked to the review of the clarificatory information sought as part of the application review process,” and “is not related to any cGMP audit observations made by USFDA at our manufacturing facilities.”
Last month, the firm announced it had sought withdrawal of its dossiers with the EMA for its trastuzumab and pegfilgrastim biosimilar products, saying at the time this was “part of the EMA procedural requirements linked to [a] re-inspection,” and a resubmission would be forthcoming.