The U.S. Food and Drug Administration (FDA) issued two Complete Response Letters (CRLs) to South Korean manufacturer Celltrion. One was for a proposed biosimilar for Genentech and Biogen’s Rituxan for lymphomas and leukemias, and a proposed biosimilar to AbbVie’s Humira for rheumatoid arthritis, plaque psoriasis, Crohn’s disease and other autoimmune disorders.
On Friday, November 17, Genentech, a Roche company, sued Pfizer in a federal court in Wilmington, Delaware, over Pfizer’s biosimilar for Genentech’s Herceptin. Genentech is claiming that Pfizer’s proposed biosimilar infringes 40 of its patents. Genentech also is demanding compensation for lost sales if Pfizer launches its copycat version before the Herceptin patents expire.
Boehringer Ingelheim has won its first biosimilar approval in Europe with authorisation of Cyltezo for a range of chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Amgen and Simcere Pharmaceutical Group today announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.
A legal brawl between two of the world’s largest drug companies could shape the future of a nascent market of copycat drugs that are intended to bring down the cost of the most advanced and expensive medicines.
The US Food and Drug Administration(FDA) has approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Roche/Genentech’s Avastin (bevacizumab) for the treatment of multiple types of cancer, making it the first biosimilar approved in the country for the treatment of cancer.
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