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Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars Posted 29/09/2017

India-based biologicals specialist Biocon announced on 16 August 2017 that it was withdrawing its European Union (EU) marketing applications for its trastuzumab and pegfilgrastim biosimilars.

The withdrawal comes as part of the European Medicines Agency’s (EMA) procedural requirements linked to the reinspection of the company’s Bangalore drug product facility.

The decision for reinspection came after the French regulatory authority (L’Agence nationale de sécurité du médicament et des produits de santé, ANSM) inspected its drug substance and drug production sites in Bangalore. Biocon received good manufacturing practice (GMP) approval for its ‘Biologics Drug Substance facilities’ from ANSM. However, ANSM decided that the company’s ‘Drug Product facility’ would require a follow-up inspection to verify that Biocon had implemented the ‘proposed corrective and preventive actions (CAPAs)’ before it would gain a GMP compliance certificate for its drug product facility [1].

Biocon said in a statement that it was ‘on track to complete our CAPAs by the end of this quarter’. The company added that it was its intention ‘to seek re-inspection and re-submission thereafter’.

The action comes as a setback for Biocon, and partner Mylan, who had been hoping to be the first on the EU market with a trastuzumab biosimilar. Biocon/Mylan submitted their applications for their pegfilgrastim and trastuzumab biosimilars to EMA for approval in July 2016 [2] and August 2016 [3], respectively.

The companies also submitted an application to the US Food and Drug Administration (FDA) for approval of their biosimilar of trastuzumab in November 2016 [4]. This approval has also been delayed, after FDA notified Mylan that it would be extending the ‘target action date’ for trastuzumab to 3 December 2017.

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Biosimilars of pegfilgrastim

References
1. GaBI Online - Generics and Biosimilars Initiative. Setback in Biocon/Mylan’s biosimilar programme after GMP inspection [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/General/Setback-in-Biocon-Mylan-s-biosimilar-programme-after-GMP-inspection
2. 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 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
3.    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 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-trastuzumab-biosimilar-to-EMA

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Source: Biocon

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