Indian company Biocon (NSE: BIOCON) has received the certificate of good manufacturing practice (GMP) compliance from the European Medicines Agency (EMA) for the manufacture of biologics drug substance (DS) and drug product (DP) at its Bengaluru site.
These facilities are used for the manufacture of DS and DP for biosimilar drugs referencing Avastin (bevacizumab), Herceptin (trastuzumab) and Neulasta (pegfilgrastim), as well as secondary packaging of insulin glargine for European Union (EU) markets. They were inspected in March of this year.
"This approval will support the penetration of trastuzumab and pegfilgrastim in Europe"The approval expands Biocon’s capacities multi-fold to address the growing needs of patients in the EU for the trastuzumab biosimilar, which was commercialized in March 2019, and for the pegfilgrastim product, which is expected to reach the market soon.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze