A German manufacturer is considering its options after the successful completion of two clinical studies involving a pegfilgrastim biosimilar (MSB11455). Fresenius Kabi, which completed its purchase of the biosimilar business from Merck KGaA in September 2017, announced its investigational biosimilar agent had proved sufficiently similar to the reference product Neulasta® in these phase 1 investigations … Continue reading Fresenius Kabi and Celltrion Get Good News
Tag: CT-P10
Celltrion’s Rituximab Biosimilar Earns Positive Review
The information package released by reviewers for the Food and Drug Administration (FDA) indicates that a positive recommendation for Celltrion’s rituximab biosimilar is likely at the Advisory Committee meeting on October 10. The members of the Oncologic Drugs Advisory Committee will review the data and hear public comments before voting to recommend that the FDA … Continue reading Celltrion’s Rituximab Biosimilar Earns Positive Review
Celltrion Bounces Back, Resubmits for FDA Approval of Rituximab Biosimilar
Anticipating that its issues with the Incheon, South Korea, manufacturing plant will be resolved, Celltrion has resubmitted its biologic license application for a rituximab biosimilar (CT-P10). In the April 2018 complete response letters sent by the Food and Drug Administration (FDA) on CT-P10 and the trastuzumab biosimilar CT-P6, FDA cited aseptic practices at the manufacturing … Continue reading Celltrion Bounces Back, Resubmits for FDA Approval of Rituximab Biosimilar
Celltrion’s Rituximab Recommended for Approval in Europe
Just weeks after Celltrion presented data at the American College of Rheumatology meeting demonstrating that its product CT-P10 is as safe and effective as Rituxan® for the treatment of rheumatoid arthritis (RA), the European Medicines Agency (EMA) received the recommendation to approve the product for use in the EU.