Eye on Pharma: Biocon Withdraws Filings for Trastuzumab, Pegfilgrastim in Europe

Yesterday, Biocon withdrew from the European Medicines Agency (EMA) its applications for the authorization of biosimilar trastuzumab and pegfilgrastim.

The withdrawal of the applications follows a French National Agency for Medicines and Health Products Safety (ANSM) inspection that found 35 deficiencies—11 of them major—in Biocon’s manufacturing practices at its Bangalore manufacturing plant. ANSM issued corrective recommendations to the drug maker and stipulated that the facility would have to be re-inspected to ensure that all its recommendations had been followed.

Biocon hopes to alleviate investor concerns about the withdrawal of its applications from the EMA; in a statement issued to the National Stock Exchange of India, Biocon said that “whilst our drug substance facilities for trastuzumab and pegfilgrasim were approved, the European regulatory authorities had informed us of the need for re-inspection of our drug product facility for these products,” and that “The request for withdrawal of the dossiers the re-submission is part of the EMA procedural requirements linked to this re-inspection.” The statement concluded with the company’s projection that it would complete the EMA’s [corrective and preventative actions] by the end of the quarter, when it would seek its re-inspection and would resubmit the 2 applications. Despite the company’s statement, shares of the biosimilar developer’s stock sank by 5.9% on news of the withdrawals.

The delay in Biocon’s EMA applications raises fresh questions about Biocon’s trastuzumab biosimilar application under review with the FDA. In July, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously to approve the drug, but with an anticipated Biosimilar User Fee Act goal date of September 3, it is unclear whether Biocon will have been able to address the issues at its facility sufficiently to meet FDA’s standards.

A recent FDA inspection of the Bangalore facility also yielded concerns about manufacturing practices, but Biocon has attempted to deflect those worries, saying in a statement that the US regulatory agency’s recent audit of its Bangalore plant concerned a small-molecule injectable drug rather than one of the biosimilars identified in the ANSM findings. The FDA inspection raised 10 concerns with the manufacturing plant’s sterility, quality control, labeling, and other critical manufacturing practices.

In an interview with ETHealthWorld, Biocon’s managing director, Kiran Mazumdar-Shaw, took a confident position about trastuzumab’s potential US approval, saying, “[The] unanimous recommendation to the US FDA for the approval of our biosimilar trastuzumab by [ODAC] endorsed the quality of our biosimilar product in terms of safety, purity and potency in comparison to the reference product. Along with our partner, Mylan, we now look forward to engage with the US FDA to seek final approval for bringing this affordable biosimilar to patients of HER2-positive breast cancers in the US.”