FDA reviewers endorse Celltrion's Rituxan biosimilar ahead of panel vote

Roche's Rituxan could come under biosimilar competition in the U.S. (Roche)

Celltrion’s biosimilar to Roche’s blockbuster Rituxan has already been rejected at the FDA once for manufacturing problems, but in the company’s second attempt, agency staffers have reacted favorably to the med. In a review document (PDF) posted ahead of an FDA panel meeting set for Wednesday, internal reviewers found no “clinically meaningful differences … in terms of safety, purity and potency” between the biosim and Roche drug.