Mylan, Biocon's biosims back on track in EU after manufacturing snag
- The European Medicines Agency has agreed to review two applications from Mylan N.V. and Biocon Ltd. for approval of biosimilar versions of the blockbuster biologics Herceptin and Neulasta, Mylan said in a Nov. 30 statement.
- Both applications were previously withdrawn by Biocon in response to an audit by the EMA of one of the Indian manufacturer's drug product facilities. Biocon has now completed the corrective and preventive actions (CAPAs) outlined in the audit, clearing the path for the recent resubmission.
- The EMA will confirm that these actions have taken place as part of the inspection required for regulatory review of the marketing authorization applications (MAAs). The CAPAs included modifications of Biocon's aseptic drug product facility, the company said.
Back in August, Biocon pulled its applications for EU approval of biosimilars to Roche's Herceptin (trastuzumab) and Amgen Inc.'s Neulasta (pegfilgrastim) — giving itself time to complete corrective actions required to bring the company's facility in Bangalore up to code.
"Having gone through initial reviews of the applications and after completing the CAPAs from the EMA audit, we are even more confident with the strength of our MAAs," said Mylan President Rajiv Malik.
"Additionally, the voluntary action indicated [VAI] designation we received from FDA gives us further confidence in the readiness of the manufacturing site," he explained, referencing a classification given by the agency to indicate technical violations that don't meet the threshold of regulatory significance.
On the other side of the Atlantic, the FDA recently approved the companies' Herceptin biosimilar, making it the first copy of the cancer biologic OK'd in the U.S. A settlement with Roche means the partners will be able to market their biosimilar in all countries outside Japan, Brazil and Mexico, although timing of a potential launch isn't clear.
- Mylan N.V. Press release
- BioPharma Dive Biocon pulls EU application for Herceptin biosimilar
Follow Suzanne Elvidge on Twitter