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
Tag: rituximab
FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar
Sandoz announced today that the Food and Drug Administration (FDA) has decided not to approve its biosimilar version of the oncology biosimilar rituximab. The content of the complete response letter was not revealed by Sandoz. This marks the second rituximab biosimilar rejected by the FDA. Celltrion and Teva’s Truxima™ was also rejected in early April. … Continue reading FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar
Teva and Celltrion Receive Rejections on Trastuzumab and Rituximab Biosimilars
Celltrion and its partner Teva were dealt a significant blow today, as the Korean manufacturer announced that the latest two biosimilar candidates were rejected by the Food and Drug Administration (FDA). As first reported by Dan Stanton in the Biopharma Reporter, the FDA issued complete response letters as a result of inspection problems uncovered at … Continue reading Teva and Celltrion Receive Rejections on Trastuzumab and Rituximab Biosimilars
Rituximab and Filgrastim Biosimilars Being Reviewed by FDA
Sandoz's Rituximab and Adello Biologic' Filgrastim Biosimilars Submitted to FDA
Biosimilar Rituximab Under FDA Review
Celltrion announced June 30, 2017 that it has submitted its 351(k) application to the Food and Drug Administration for approval of its biosimilar version of rituximab. This represents the first biosimilar application for rituximab, a monoclonal antibody to CD20.
Will Oncology Biosimilars Ease US Access Problems?
With shallow discounts for the biosimilars, the originator’s manufacturer can simply match the net cost through deeper rebates; the payer would have little reason to change the formulary tiering of the biologic.
Second European Medical Society Endorses Biosimilar Use
Although the European Medicines Agency (EMA) does not have a mechanism for approving the interchangeability of biosimilars with the originator drugs, this decision on drug switching is left to the EU member states.
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.