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FDA Accepts Proposal for Biosimilar to Rituxan
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Sandoz, a Novartis Division, announced the FDA has accepted its biologics license application under the 351(k) pathway for a proposed biosimilar to Rituxan, used to treat rheumatoid arthritis and blood cancers.
According to a company press release, the biologics license application consists of analytical, preclinical and clinical data, including a pharmacokinetic/pharmacodynamic trial in rheumatoid arthritis and a phase 3 confirmatory safety and efficacy study in follicular lymphoma. The company notes these data provide confirmation that the proposed biosimilar matches Rituxan (rituximab) in terms of safety, efficacy and quality.
“The cost of treating cancer in the U.S. is a major concern for many patients and their families as well as for the health care system,” Mark Levick, MD, PhD, global head of development, biopharmaceuticals for Sandoz, said in the release. “With the FDA acceptance of our regulatory submission for proposed biosimilar rituximab, we plan to deliver patients a high-quality Sandoz biosimilar that, following approval, could help drive health care savings and increase competition, while freeing up resources for and supporting patient access in other areas of cancer care including innovative therapies.”
Reference:
www.sandoz.com/news/media-releases/sandoz-proposed-biosimilar-rituximab-accepted-review-fda