Biocon`s biosimilars program fails European cGMP inspection

India’s pharma stocks have been taking a beating of late due to compliance-related issues and the pressures on the US market, putting a big question mark on the growth of the country’s pharmaceutical industry in the future. 

So far, Biocon had been able to weather this storm due to its successful compliance record, and an exclusive strategic partnership with Mylan for a broad portfolio of biosimilars and generic insulin analogs, which in turn were expected to bring in a windfall for the company.

However, Biocon’s biosimilar program suffered a serious setback as an inspection by the French health agency, ANSM, in March 2017 of its site located in Bengaluru, India, uncovered 35 deficiencies, of which 11 were deemed major.

 The inspection was conducted on behalf of the European Medicines Agency (EMA) by the ANSM as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (Pegfilgrastim), Ogivri® (Trastuzumab) and Semglee® (Insulin glargine).

Need for a follow-up GMP inspection

The ANSM found major deficiencies in the following areas: Environmental monitoring-training, OOS results management, cleaning validation, process validation, vendors qualification, media fill test, cross-contamination risks, batch manufacturing record, differential pressure alarms’ management in classified areas and access management in SAP for batch certification.

The agencies concluded that the European Marketing Authorization Applications of the three biosimilar products currently under assessment should not be approved while the non-compliance report is in effect.

The report also mentions that a follow-up GMP inspection is required in order to ensure that all the corrective and preventive action (CAPA) plans have been implemented and finalized by the site and that a robust quality system is in place.

Biocon and Mylan have made two submissions to the FDA for their biosimilars of Amgen’s Neulasta (pegfilgrastim) and Roche’s Herceptin (trastuzamab). 

Now, it remains to be seen if the verdict of the FDA will be any different from that of the European agencies.



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