Posted by Michael Wonder on 07 Apr 2018
FDA rejects Teva/Celltrion biosimilars
6 April 2018 - Teva and Celltrion’s attempt to muscle in on the multi-billion dollar US cancer and inflammatory disease drug market has hit a setback after the FDA rejected two key biosimilars because of manufacturing problems.
The companies filed biosimilars of Roche’s big-selling Rituxan (rituximab) for inflammatory diseases and certain blood cancers, and Herceptin (trastuzumab) for breast and gastrointestinal cancer with the FDA last year.
But following an inspection of Celltrion’s manufacturing site in South Korea, the FDA issued a warning letter highlighting issues such as poor aseptic practice during filling of batches, and slow follow-up to complaints regarding defective batches.
