Three Key Biocon Products Fail French Health Authority Inspection
French regulator inspection points to 11 major deficiencies at Biocon’s process for 3 products.
Biocon Ltd. has failed to comply with good manufacturing practices (GMP) for activities related to three products at its Bommasandra facility in Bengaluru, according to France’s health regulator ANSM.
In a report filed on the European Medicines Agency’s website, the French regulator found concerns with sterile products, biological medicinal products, packaging and quality control testing at the Biocon unit.
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.
What This Means For Biocon
- Delay in getting approvals from Europe.
- May have implications on approvals from the United States Food and Drug Administration.
- Analysts who have considered Trastuzumab in their estimates may cut targets.
- Two active pharmaceutical ingredient (API) sites getting cleared may be taken as a positive trigger.
In a statement to the stock exchanges, Biocon says that there were no critical observations in the final report. The pharma company says it was told by the ANSM that a follow-up inspection was required in order to receive a go-ahead certificate for the drugs. Biocon has said it will work with the authorities to ensure the plant is cleared soon.