Sandoz Receives EMA’s CHMP Positive Opinion of Biosimilar Natalizumab for Multiple Sclerosis
Shots:
- The EMA’s CHMP has adopted a positive opinion regarding marketing authorization for natalizumab, a first-of-a-kind biosimilar for multiple sclerosis. Polpharma Biologics developed biosimilar natalizumab & will be commercialized by its collaboration partner Sandoz
- The opinion was based on evidence from extensive analytical characterization incl. P-I PK/PD study & confirmatory P-III study (Antelope) in RRMS patients. Both studies met their 1EPs & showed similarity of the biosimilar with reference biologic in terms of PK, efficacy, safety, and immunogenicity
- The EC marketing authorization is valid in all EU Member States, as well as EEA countries Iceland, Liechtenstein, Norway & Northern Ireland under the Northern Ireland Protocol
Ref: Sandoz | Image: Sandoz
Related News:- Biogen Requests a Preliminary Injunction in BPCIA Case Against Sandoz Proposed Biosimilar of Tysabri (natalizumab)
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