Sandoz Obtains Positive CHMP Opinion For Multiple Sclerosis Biosimilar Natalizumab

(RTTNews) - Sandoz said Monday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion for marketing authorization for first-of-a-kind biosimilar natalizumab developed by Polpharma Biologics.

The authorization covers treatment as a single disease-modifying therapy (DMT) in adults with highly active relapsing-remitting multiple sclerosis (RRMS), the same indication as approved by the EMA for the reference biologic.

The company noted that the positive CHMP opinion was based on evidence from extensive analytical characterization confirming similarity of biosimilar with reference biologic, in addition to Phase I and confirmatory Phase III studies in relapsing-remitting multiple sclerosis patients.

Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. As per the agreement, Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing, and supply of drug substance. Sandoz has the rights to commercialize and distribute it in all markets.

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