Biotech company, Biocon will see two crucial inspections later this month and in early April. Company’s manufacturing sites will come up for inspections by the European medicines agency later this month and next will be an inspection by the US FDA, say sources.
This is an important development for the company. US FDA in January and February had accepted two applications of Biocon for Pegfilgrastim and Trastozomab. The inspection process will give an idea to the company on how well it is prepared for the regulatory process.
The Bengaluru Biologics facility is likely to be inspected by EMA in March second week and the US FDA inspection will be carried by March end or April first week. .
"As a policy we do not comment on the schedule of regulatory inspections nor the outcome. So far we have enjoyed a good track record,” the company said.
Pegfilgrastim is used to boost white blood cells in cancer patients and Trastozomab is used in the treatment of certain types of breast cancer.