Indications expanded for Merck’s etanercept biosimilar Brenzys Posted 25/09/2020

The indications of Merck Canada’s etanercept biosimilar Brenzys have been expanded to include plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis.

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, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

In North America, etanercept is marketed by Amgen under the trade name Enbrel in two separate formulations, one in powder form, the other as a pre-mixed liquid. There are various biosimilar versions of the drug, such as Benepali (Samsung Bioepis) [1] and Nepexto (Mylan) [2].

Merck has also produced a biosimilar of etanercept, called Brenzys, which was approved by Health Canada in 2016 [3]. The original approval however was only for the treatment of adult patients with moderate to severe rheumatoid arthritis and ankylosing spondylitis.

In September 2020, Merck Canada announced that Brenzys has now been approved for the use of additional indications: plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis. This could significantly increase market share for Merck, as approximately one million people in Canada live with psoriasis and 10%–30% of these will go on to develop psoriatic arthritis.

The detailed list of additional indications is as follows:

• Adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy
• Paediatric patients aged 4 to 17 with chronic severe plaque psoriasis who are candidates for systemic therapy or phototherapy
• Reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis and improving physical function in adult patients with psoriatic arthritis
• Reducing signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis in patients aged 4 to 17 who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.

Outside of Canada, Brenzys is being supplied to Brazil via Samsung Bioepis over a 10-year partnership [4]. The drug has also been approved for substitution in Australia [5].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Benepali gains approval for extra indications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Biosimilars/News/Benepali-gains-approval-for-extra-indications  
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for etanercept biosimilar Nepexto [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-etanercept-biosimilar-Nepexto  
3. GaBI Online - Generics and Biosimilars Initiative. Canadian approval for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Biosimilars/News/Canadian-approval-for-etanercept-biosimilar  
4. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis to supply Brenzys to Brazil under production development partnership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-to-supply-Brenzys-to-Brazil-under-production-development-partnership  
5. GaBI Online - Generics and Biosimilars Initiative. Australia says etanercept biosimilar can be substituted [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Sep 25]. Available from: www.gabionline.net/Biosimilars/News/Australia-says-etanercept-biosimilar-can-be-substituted 

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Source: Merck Canada

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