Kiran Mazumdar Shaw, the MD of Biocon said that the company will "expeditiously address" manufacturing practice violations raised by France’s health regulator. The company's share price fell sharply yesterday after the ANSM report was made public.
Shaw said that remedial measures are in progress, after French regulator ANSM's inspection report found 35 deficiencies. It has barred biosimilar products Fulphila (Pegfilgrastim), Ogivri (Trastuzumab) and Semglee (Insulin glargine) from France. Trastuzumab in particular, a breast cancer treatment drug, has been championed by Biocon as a key sales driver for FY18.
Shaw insisted that the issues can be resolved within the quarter - the company plans to call for a reinspection, she said, after remedial processes are in place.