Biocon/Mylan’s biosimilar programme has hit a stumbling block after failing an inspection by the French inspecting authority (L’Agence nationale de sécurité du médicament et des produits de santé: ANSM).
India-based biologicals specialist Biocon announced on 9 July 2017 that, although it had received good manufacturing practice (GMP) approval for ‘Biologics Drug Substance facilities’ from ANSM, its ‘Drug Product facility’ would have to be reinspected.
The inspection was carried out at its Bangalore drug substance and drug product sites, where ANSM found issues with its product plant. Biocon said that although there were ‘no critical observations’, the site will require a follow-up inspection to verify that Biocon has implemented the ‘proposed corrective and preventive actions (CAPAs)’ before it will gain a GMP compliance certificate for its drug product facility.
The decision affects the pending European Medicines Agency (EMA) Marketing Authorization Applications for trastuzumab, pegfilgrastim and insulin glargine (pen assembly only). Biocon/Mylan submitted their application for their pegfilgrastim biosimilar to EMA for approval in July 2016 [1]. The application for their trastuzumab biosimilar was submitted to EMA in August 2016 [2]. The application for their insulin glargine biosimilar was submitted to EMA in November 2016 [3].
Biocon said that the ANSM has ‘reviewed the proposed CAPA plan’ and that it ‘is progressing towards completion of the implementation of these CAPAs’. The company added that, along with its partner US generics maker Mylan, it ‘will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the Marketing Authorization Applications with the goal of an early reinspection’.
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogues [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit pegfilgrastim biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit trastuzumab biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-EMA
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit insulin glargine biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-insulin-glargine-biosimilar-to-EMA
4. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to parter on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 11]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products
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