Biogen Reports the EMA Acceptance of MAA for BIIB800 (biosimilar, tocilizumab)

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Biogen Reports the EMA Acceptance of MAA for BIIB800 (biosimilar, tocilizumab)


  • The EMA has accepted the MAA for BIIB800, a biosimilar referencing RoACTEMRA (tocilizumab). RoACTEMRA is indicated as an IV formulation for RA & JIA
  • The MAA was based on the P-III trial evaluating BIIB800 vs RoACTEMRA in 621 patients with mod. to sev. RA with inadequate response to methotrexate which showed that biosimilar BIIB800 was equivalent to the reference tocilizumab in terms of efficacy, PK, safety & immunogenicity profile
  • On April 2021, Biogen & Bio-Thera collaborated to develop, manufacture & commercialize BIIB800 where Biogen gets exclusive regulatory, manufacturing & commercial rights for BIIB800 in all countries excl. China (incl. Hong Kong, Macau & Taiwan)

Ref: Globenewswire | Image: Biogen

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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