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Canadian approval for etanercept biosimilar Posted 16/09/2016

Merck Canada announced on 12 September 2016 that it had received approval for its etanercept biosimilar Brenzys (SB4) from Health Canada – the first subcutaneous anti-tumour necrosis factor (anti-TNF) biosimilar available in Canada.

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. The originator biological Amgen’s Enbrel (etanercept) is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Brenzys, however, has only been approved for the treatment of adult patients with moderate to severe rheumatoid arthritis and ankylosing spondylitis.

The approval of Brenzys in Canada was based on data ‘demonstrating that Brenzys had comparable efficacy and safety to the originator biologic Enbrel’, according to Dr Janet Pope, Division Head in Rheumatology at St Joseph’s Health Centre, Toronto, Canada. The data included rigorous analytical, structural and functional testing, as well as a phase III clinical study comparing Brenzys to the originator medicine (Enbrel) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy [1]. Long-term safety and efficacy data in patients with rheumatoid arthritis comparing continuing Brenzys and switching from Enbrel to Brenzys was also included.

Biologicals are one of Canada’s fastest-growing segments in pharmaceutical spending, biologicals showed a growth rate for the 12 months ending May 2016 of 9.7%, compared to the total market growth rate of 6.3%.

The originator product, Amgen’s Enbrel (etanercept), had sales of US$4.7 billion in 2014, making it one of the top selling biologicals and a lucrative target for biosimilars developers. The patents on Enbrel expire in the US in November 2028, after Amgen was granted a new patent, and in Europe in August 2015 [2, 3].

The approval of Brenzys in Canada on 31 August 2016 follows the approval of the biosimilar in Korea a year ago in September 2015 [4]. The biosimilar (SB4) was also approved in Europe as Benepali in January 2016 [5].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for candidate etanercept and infliximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-candidate-etanercept-and-infliximab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
3. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-approved-in-South-Korea
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Merck Canada

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