Last week Biocon announced that it has received EU GMP certification for its biosimilars facility in Bangalore, after an inspection by European agencies this past March. Biocon’s Bangalore biosimilar facilities were also inspected earlier this year by the FDA, and last month Biocon announced the FDA issued an Establishment Inspection Report stating “that the inspection stands closed.”
We previously have reported on Biocon’s biosimilar pipeline, including its recent joint approval in the United States with Mylan of Fulphila™, a pegfilgrastim biosimilar. In Europe, Biocon recently obtained joint approval in Europe with Mylan for Semglee™, an insulin glargine biosimilar.