Mumbai: Biocon Ltd's biosimilars programme for Europe has hit a roadblock with French health regulator ANSM finding lapses in quality compliance at its Bengaluru plant during a inspection in March this year.
In a stock exchange filing on Sunday, Bengaluru-based Biocon said that the French regulatory agency had conducted pre-approval inspection audits of its drug substance and drug product manufacturing facilities in Bangalore on behalf of the European Medicines Agency (EMA).
The inspections related to the pending EMA marketing authorisation applications by Biocon for its biosimilar products Trastuzumab, pegfilgrastim and insulin glargine, Biocon said in its filing to the Bombay Stock Exchange.
Reacting to the news, Biocon shares fell 9 per cent in mid-morning to afternoon trading on the BSE, but had recovered to 5 percent levels close to the end of the trading day.
The company said that ANSM made no critical observations in its final report but proposed a few corrective actions. ANSM has informed it that a follow-up inspection would be required by the French agency to verify if these actions were being implemented before issuing a good manufacturing practices (GMP) compliance certificate for its products facility, Biocon said.
"ANSM has reviewed the proposed CAPA plan and Biocon is progressing towards completion of the implementation of these CAPAs," Biocon said.
Until the drug product facility gets clearance, Biocon will not get marketing approval for its biosimilars.
The French regulator, however, has issued GMP certificates for Biocon's two drug substance manufacturing units in Bengaluru. The company said that the manufacture of these two substances is crucial to the production of the actual biologic product relating to GMP compliance.
While Biocon did not specify the nature of the lapses, financial daily HT Mint on Monday cited a newsletter by Pharmacompass, a business intelligence and connection platform for pharma companies, as saying that the March 13-17 inspection at the Bengaluru plant raised 35 deficiencies, including 11 major deficiencies.
It said the deficiencies were related to environmental monitoring and training, management of results of out-of-specification products, cleaning validation, process validation, vendors' qualification, cross contamination risks, and batch manufacturing records, among others, HT Mint reported.
"Biocon, along with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the marketing authorisation applications with the goal of an early re-inspection," Biocon said in the filing.
The company has also filed applications for biosimilars trastuzumab and pegfilgrastim with the US Food and Drug Administration (FDA), HT Mint added.
Biocon expects revenue from its biologics portfolio in regulated markets such as the US and Europe to kick in from financial year 2018-19.