Celltrion announced last week that it has submitted an application for approval of Herzuma, its proposed trastuzumab biosimilar (CT-P6), in Japan. Trastuzumab is a monoclonal antibody indicated for the treatment of patients with metastactic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens. Celltrion’s Herzuma (trastuzumab) is
FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017. Renflexis® is the fifth biosimilar approved by the FDA and the second infliximab biosimilar to Janssen’s Remicade®. Infliximab is an Anti-Tumor Necrosis Factor (Anti-TNF) monoclonal antibody approved in the U.S. for treating rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and
Amgen’s Amgevita, an adalimumab biosimilar to AbbVie’s Humira®, received approval from the European Commission on March 23, 2017. Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α) preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases.
Amgevita received approval in all available indications, including the
Celltrion’s Truxima (CT-P10, rituximab), a biosimilar to Rituxan® received approval from the European Commission on February 22, 2017. Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma, chronic lyphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis, and microscopic polyangitis. The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Truximab for
The FDA has accepted for review an application submitted by Mylan N.V. (“Mylan”) and Biocon Ltd. (“Biocon”) under the 351(k) pathway for MYL-1401K, a proposed biosimilar to Amgen’s Neulasta® (pegfilgrastim). According to the announcement, the BSUFA date (FDA’s target goal) for a decision on the application is October 9, 2017.
The FDA has not
Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team at CDER, recently participated in a podcast on biosimilars. During the discussion, she provided a “snapshot” of the biosimilar landscape at FDA.
According to Dr. Christl, as of February 1, 2017, there are 64 programs enrolled
Introduction
The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological products shown to be “highly similar” to already FDA-approved biological products. By permitting the sponsor of a biological product to rely on data submitted by the holder of an FDA-approved biological product, the BPCIA is somewhat similar in concept
On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming of Biological Products.” According to FDA, the nonproprietary naming convention provided in the final guidance is intended to aid pharmacovigilance and to help prevent confusion and inadvertent substitution.
FDA’s newly-issued guidance covers the nonproprietary naming convention