Meeting Highlights from the Committee for Medicinal Products for Human Use

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The European Medical Agency’s Committee for Medicinal Products for Human Use (CHMP) recently reported biosimilar updates from its March 2020 meeting.  At the meeting, Mylan and Lupin’s NEPEXTO (etanercept) received a positive opinion for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.  The CHMP opinion will now be considered for approval by the European Commission before being marketed by member countries in the EU, which is expected in May 2020.  CHMP also reported that applications for initial marketing authorization for two rituximab biosimilars were withdrawn.  These biosimilars were intended for the treatment of certain blood cancers and inflammatory conditions.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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