The etanercept biosimilar Rymti, produced by Lupin, received approval from Canada’s drug regulator, Health Canada (HC), on 13 September 2022, for all indications of the reference product Enbrel. This is the third etanercept biosimilar to receive approval in Canada [1].
A Notice of Compliance is issued to a manufacturer following the satisfactory review of a submission.
Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis [2].
Rymti is indicated in 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, and is available as an injectable easy-to-use pre-filled pen and a pre-filled syringe.
The Summary Basis of Decision for Rymti is yet to be published by HC.
‘The approval for Rymti in Canada is a key milestone in our endeavors to improving access to medicines. It underscores the scientific success of Lupin’s biosimilar programs and our commitment to advancing healthcare through innovation’, said Dr Cyrus Karkaria, President of Lupin Biotech.
On 25 May 2018, Lupin announced that its candidate etanercept biosimilar (YLB113) had been accepted for regulatory review by the European Medicines Agency (EMA) [3].
Almost one year later, on 26 March 2019, Lupin announced that its joint venture YL Biologics and Lupin had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its etanercept biosimilar YLB113 in Japan. In Japan, there was already one etanercept biosimilar approved. The PMDA approved Japan-based Mochida Pharmaceutical’s Etanercept BS (etanercept biosimilar 1) in January 2018 and was launched in May 2018 [3, 4].
The first biosimilar to receive approval in Canada was Sandoz’s growth hormone treatment Omnitrope in 2009. In 2010, Health Canada finalized guidelines for biosimilars, which were previously called subsequent entry biologics in Canada [1].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of etanercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-etanercept
3. GaBI Online - Generics and Biosimilars Initiative. Etanercept biosimilars submitted to EMA and launched in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from:
www.gabionline.net/biosimilars/news/Etanercept-biosimilars-submitted-to-EMA-and-launched-in-Japan
4. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for Lupin’s etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 1]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-Lupin-s-etanercept-biosimilar
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