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
Tag: FDA Advisory Committee
FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further
When the Food and Drug Administration (FDA) approved the first biosimilar pegfilgrastim (Mylan’s Fulphila™), it broke precedent in more ways than one. Not only was this the first biosimilar member of the pegfilgrastim class to be approved, but its approval did not require an FDA Advisory Committee recommendation. The FDA has been a bit fuzzy … Continue reading FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further
A Test for Adello and for FDA’s Biosimilar Approval Pathway
We are on the verge of a few eagerly awaited decisions by the Food and Drug Administration (FDA). Celltrion and its partner Pfizer expect to hear news on their trastuzumab biosimilar in April, as does Celltrion separately on its rituximab biosimilar. These should make a significant impact on the evolution of biosimilars in the US … Continue reading A Test for Adello and for FDA’s Biosimilar Approval Pathway
FDA Approves New Humira Biosimilar, Bypasses Advisory Board Route
Boehringer Ingelheim Pharmaceuticals, Inc. announced August 29 that it had received approval from the Food and Drug Administration (FDA) for its first biosimilar. Named Cyltezo™ (adalimumab-adbm), a biosimilar to Humira®, it is approved for several autoimmune disorders, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease in adults, plaque psoriasis, and … Continue reading FDA Approves New Humira Biosimilar, Bypasses Advisory Board Route
Mylan and Biocon Withdraw Two EMA Biosimilar Applications
This action could potentially create considerable problems for the partners Mylan and Biocon. They have the opportunity to be first-to-market in the US with regard to both biosimilar products.
Two New Trastuzumab Biosimilars Submitted for FDA Approval
The team of Mylan and Biocon may have some company in the biosimilar competition for Herceptin® (trastuzumab). Two additional partnerships announced the filing of their 351(k) applications for trastuzumab biosimilars. Amgen and Allergan are hoping ABP 980 will have smooth sailing through the approval system. The phase 3 study in patients with early-stage HER2-positive breast … Continue reading Two New Trastuzumab Biosimilars Submitted for FDA Approval
FDA Advisory Committee Unanimously Recommends Approval for Avastin® and Herceptin® Biosimilars
Amgen and Allergan’s ABP-215 was convincingly presented as equivalent to Roche's bevacizumab (Avastin®). The totality of evidence, according to the FDA staff review documents, supported the 351(k) application by Mylan. The Advisory Committee agreed, voting 16-0 to recommend the biosimilar for approval for use in Herceptin’s indications.
FDA Stuns With Rejection of Pfizer’s Retacrit
Following a 14-1 vote by its Oncology Drug Advisory Committee last month to recommend approval for Pfizer’s biosimilar version of Epogen®, the Food and Drug Administration (FDA) on June 22 sent the drug maker a complete response letter outlining its decision to reject the product.
Pfizer’s Epogen® Biosimilar Gets FDA Advisory Committee Backing
According to the FDA’s staffers’ summary released ahead of the May 25th Oncology Advisory Committee review, Retacrit fulfilled the requirements for biosimilarity. Today, the Advisory Committee added further support to this conclusion by voting 14-1 to recommend approval for all extrapolated indications, despite some safety concerns expressed by committee members.