FDA declines proposed Rituxan, Herceptin biosimilars from Celltrion
Healio Rheumatology reported that the FDA rejected the approval of a biopharmaceutical company's biologics license applications.
HSS rheumatologist Allan Gibofsky, MD, noted that this rejection demonstrates the careful scrutiny that the FDA applies to both the manufacturing process and quality control of biologic products.
"While I don't think this rejection will 'shake' consumer or prescriber confidence in biosimilars, I do think it will make both stakeholders look carefully at the reputation of the manufacturer and, where appropriate, any manufacturing partner they may have," said Dr. Gibofsky.
Read the full article at healio.com [registration required].