Biocon’s biosimilars plant gains clearance from FDA

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Biocon’s biosimilars plant gains clearance from FDA

Biosimilars/General | Posted 05/10/2018 0 Post your comment

India-based biologicals specialist Biocon has stated that its biosimilars plant has received a clean bill of health, indicating that it is now compliant with US Food and Drug Administration (FDA) manufacturing requirements.

The company announced on 23 June 2018 that it had received an Establishment Inspection Report (EIR) from FDA on closure of inspection of its sterile drug product manufacturing facility in Bangalore, India.

Biocon confirmed in a filing with the Bombay Stock Exchange that it had received an EIR from FDA for its sterile drug product manufacturing facility in Bangalore, following the US FDA pre-approval/inspection of this facility in April/May 2018. It said that the EIR notified that the ‘inspection stands closed’ and added that ‘Biocon is committed to global standards of quality and compliance’.

Biocon’s difficulties began in spring 2017 when FDA criticized the company’s Bangalore drug product facility and highlighted ‘corrective and preventive actions’ that were required before it would gain a good manufacturing practice (GMP) compliance certificate [1]. This led to the agency issuing a complete response letter (CRL) for its partner Mylan’s application for their proposed pegfilgrastim biosimilar MYL‑1401H, thus delaying approval [2]. The duo withdrew European Union marketing applications for trastuzumab and pegfilgrastim biosimilars in August 2017 due to the same issues [3].

The clearance of the plant should mean that there are no further hurdles to approval of the duo’s pegfilgrastim and trastuzumab biosimilars. It is also good news for Biocon’s global partnership with Sandoz, which the company made in January 2018, to develop, manufacture and commercialize new next-generation biosimilars [4].

References
1. GaBI Online - Generics and Biosimilars Initiative. Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Biosimilars/General/Biocon-withdraws-EU-applications-for-trastuzumab-and-pegfilgrastim-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA delays approval of Biocon/Mylan’s pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-delays-approval-of-Biocon-Mylan-s-pegfilgrastim-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Biosimilars/General/Biocon-withdraws-EU-applications-for-trastuzumab-and-pegfilgrastim-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Biocon and Sandoz join forces for global next-generation biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 5]. Available from: www.gabionline.net/Pharma-News/Biocon-and-Sandoz-join-forces-for-global-next-generation-biosimilars

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Source: Biocon