Biocon To Resubmit Filings with EMA for Biosimilars Over ManufacturingBy
Biocon, a Bangalore, India-based pharmaceutical manufacturer, plans to resubmit its marketing authorization application (MAA) to the European Medicines Agency (EMA) for biosimilar candidates to Roche’s Herceptin (trastuzumab), a cancer drug, and Amgen’s Neulasta (pegfilgrastim), a drug to stimulate white-blood cell production after chemotherapy, following an inspection of manufacturing facilities making these products. The products are top-selling products for the innovator companies. Roche’s Herceptin had 2016 sales of CHF 6.78 billion ($7.04 billion), and Amgen’s Neulasta had 2016 sales of $4.65 billion.
In July 2017, Biocon was cited by French regulatory authorities for good manufacturing practice deficiencies in a drug-product manufacturing plant that was to make pending biosimilars, including trastuzumab and pegfilgrastim. While European regulatory authorities approved the drug-substance facilities for manufacturing trastuzumab and pegfilgrastim, regulators informed the company that there is need for a reinspection of its drug-product manufacturing facility. The request for re-submission is part of the EMA’s procedural requirements linked to the reinspection and will be considered by the EMA’s Committee for Medicinal Products for Human Use, an EMA advisory committee that reviews drug applications. The EMA had earlier accepted Biocon’s MAAs for trastuzumab and pegfilgrastim in 2016. Trastuzumab and pegfilgrastim are two of six biosimilars in which Biocon is partnered with Mylan for development for the global marketplace.
Biocon says it is on track to complete the corrective and preventive actions at its drug-product manufacturing facility by the end of the third quarter of 2017 and intends to seek reinspection and resubmission thereafter.
In July 2017, an advisory committee of the US Food and Drug Administration recommended Biocon’s and Mylan’s trastuzumab biosimilar for approval. In February 2017, the FDA accepted the companies’ application for a biosimilar of pegfilgrastim.