Blog Big Molecule Watch September 27, 2022

Lupin Announces Approval of ENBREL Biosimilar in Canada

On September 13, 2022, Lupin Ltd. (“Lupin”) announced that its RYMTI product, a biosimilar to ENBREL (etanercept), has been approved in Canada.  Lupin, based in Mumbai, India, specializes in cardiovascular, diabetic, and respiratory disease treatments.  RYMTI is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and paediatric plaque psoriasis.

In June 2020, the European Commission granted marketing authorization for Lupin’s etanercept biosimilar, branded as NEPEXTO, for all indications of the reference product, ENBREL, and Lupin launched the product in the EU in September 2020.  Lupin’s etanercept biosimilar was also approved and launched in Japan in 2019.

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