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 The leading web portal for pharmacy resources, news, education and careers November 20, 2017
Pharmacy Choice - Pharmaceutical News - Novartis: FDA To Review BLA For Proposed Biosimilar Rituximab - November 20, 2017

Pharmacy News Article

 9/12/17 - Novartis: FDA To Review BLA For Proposed Biosimilar Rituximab

BASEL (dpa-AFX) - Sandoz, a Novartis Division, announced the US FDA has accepted its Biologics License Application under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan (rituximab). Rituxan is used to treat blood cancers including non-Hodgkin's lymphoma and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis.

The BLA consists of a data package that includes analytical, preclinical and clinical data. Clinical studies included a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST-RA), and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL). Sandoz believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy and quality.



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