Biocon Will Address French Regulator’s Observations Expeditiously, Says Kiran Mazumdar-Shaw
Biocon will seek early reinspection of Bengaluru facility, says Biocon managing director.
Biocon Ltd. said it will expeditiously address the manufacturing practice violations raised by France’s health regulator.
"There are a few observations that need to be dealt with via remedial measures, we are attending to them right now," the biotechnology firm’s Managing Director Kiran Mazumdar-Shaw told BloombergQuint on the phone.
In a report filed on the European Medicines Agency’s website, the French regulator ANSM found concerns with sterile products, biological medicinal products, packaging and quality control testing at Biocon’s unit.
“We can address these very expeditiously, and then we will call for a reinspection,” Shaw added.
Shares of the Bengaluru-based firm fell as much as 9.5 percent to Rs 305, before paring losses and trading 4.6 percent lower as of 10:50 a.m.
Three Products Fail Tests
The inspection was conducted by ANSM on behalf of the European Medicine Agency between March 13 and March 17. The report lists deficiencies concerning biosimilar products named Fulphila (Pegfilgrastim), Ogivri (Trastuzumab) and Semglee (Insulin glargine).
The non-compliance report was based on drug product manufacturing activities related only to these three products.
The report following the inspection pointed out 35 deficiencies, including 11 major deficiencies at the plant.
Two drug facilities received good manufacturing practice certification, and only one multi-product facility received observations, Biocon’s managing director clarified.
The remediation process can be completed in a quarter, said Mazumdar-Shaw, even as she refused to share details of the measures that the company plans to take.
In our estimation, this should not materially impact our commercialization timeline.Kiran Mazumdar-Shaw, Managing Director, Biocon