Biocon Receives Second Bs-aspart CRL; EMA Approves Malaysian Facility

Biocon disclosed that the company received a second CRL from FDA regarding its bs-aspart BLA filed by Viatris  (view announcement). For context, Biocon received its first bs-aspart CRL from FDA in January 2022 (view Biocon announcement). In the same announcement, Biocon noted its integrated insulin manufacturing facility in Malaysia was approved by EMA following a July 2022 site inspection. Below FENIX provides brief thoughts on the new CRL and potential impact on the bs-aspart approval timeline.

About The Author

Matthew Maryniak

President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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