FDA delays approval of Biocon/Mylan’s pegfilgrastim biosimilar

Biosimilars/News | Posted 20/10/2017 post-comment0 Post your comment

India-based biologicals specialist Biocon announced on 10 October 2017 that it has been informed by the US Food and Drug Administration (FDA) that its pegfilgrastim biosimilar, which it is developing jointly with Mylan, cannot be approved at present.

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Biocon said that it received a complete response letter (CRL) from FDA for its partner Mylan’s application for approval of their proposed pegfilgrastim biosimilar MYL‑1401H. The CRL relates to the update of the biosimilar application with chemistry, manufacturing and control (CMC) data after Biocon made plant modifications requiring ‘requalification’ at its Bangalore facility. The company points out that ‘the CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity’.

Biocon/Mylan submitted their biosimilar application for MYL‑1401H to FDA in February 2017. The CRL will delay the approval of MYL‑1401H. However, Biocon states that it does not expect it to impact the timing for the launch of biosimilar pegfilgrastim in the US and that it is ‘working with the agency to resolve the issues stated in the CRL expeditiously’.

This is yet another setback for the Biocon/Mylan partnership. The duo withdrew European Union (EU) marketing applications for trastuzumab and pegfilgrastim biosimilars in August 2017 after a re-inspection of the company’s Bangalore drug product facility highlighted ‘corrective and preventive actions’ that were required before it would gain a good manufacturing practice (GMP) compliance certificate. This was followed by an announcement that approval of the partnership’s trastuzumab biosimilar had been delayed in the US, after FDA notified Mylan that it would be extending the ‘target action date’ for trastuzumab to 3 December 2017 [1].

However, on a more positive note, none of the pegfilgrastim biosimilars that have been filed with FDA received approval in the first review cycle. Delays in approvals and launch timelines for Biocon/Mylan’s rivals – Apotex, Sandoz, Coherus [2] – to the end of 2018 should mean that they will still be among the first wave of launches.

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Biosimilars of pegfilgrastim

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 2017 Oct 20]. Available from: www.gabionline.net/Biosimilars/General/Biocon-withdraws-EU-applications-for-trastuzumab-and-pegfilgrastim-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA rejects pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-pegfilgrastim-biosimilar-from-Coherus

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Source: Biocon

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