Biosimilar launches in Canada and US: Byooviz and Stimufend

In Canada, Biogen announced that their Byooviz (ranibizumab) injection, a biosimilar of Lucentis, is available as of March 2023. In the preceding month, Fresenius Kabi launched Stimufend (pegfilgrastim-fpgk), a biosimilar of Amgen’s Neulasta, in the US.

Byooviz launch in Canada
The announcement of the launch of biosimilar ranibizumab Byooviz in Canada comes a year after the approval of the product. Byooviz is produced by Samsung Bioepis and commercialized by Biogen.

Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor alpha (VEGF-A). Ranibizumab can be used to treat macular degeneration by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The monoclonal antibody drug is indicated for the treatment of wet age-related macular degeneration (AMD), macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss [1].

The originator, Lucentis was developed by Roche (Genentech) and had a global revenue of around US$3.4 billion in 2021, with just over 40% of sales in the US [2]. Lucentis’ US patent expired in 2020 and its European in 2022 [3].

In Canada, Byooviz (SB11) was approved for the treatment of neovascular (wet) AMD; visual impairment due to diabetic macular oedema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and CNV secondary to ocular conditions other than AMD or PM, including but not limited to angioid streaks, post-inflammatory retinochoroidopathy, central serous choriorentinopathy or idiopathic chorioretinopathy [4, 5]. Byooviz has also been approved in the US, Europe and the UK [6, 7] and is now the first product referencing Lucentis to launch in Canada.

‘Canadians with retinal vascular disorders now have a new treatment available with Byooviz, a biosimilar that provides these patients the option to be treated with an effective therapy, with the added benefit of cost savings to the healthcare system’, said Eric Tse, General Manager at Biogen Canada.

Stimufend in the US
Fresenius Kabi's first US approved biosimilar, Stimufend (pegfilgrastim), was launched in February 2023 following its approval by the Food and Drug Administration (FDA) in September 2022 [8].

Pegfilgrastim is a supportive care medicine for patients with non-myeloid cancer. It stimulates the growth of certain white blood cells (neutrophils), which are essential to prevent or fight infections, a common life-threatening risk in patients receiving myelosuppressive chemotherapy. It is a is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim [9].

Stimufend® is commercially available in a 6 mg/0.6 mL solution in a single-dose pre-filled syringe combined with a passive needle guard.

The product was launched in France in October 2022, following the European Commission’s (EC) marketing authorization granted in March 2022 [10].

EC and FDA approval for first ranibizumab biosimilar Byooviz

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 31]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
2. GaBI Online - Generics and Biosimilars Initiative. Byooviz: first ophthalmology biosimilar launches in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 31]. Available from:
www.gabionline.net/biosimilars/news/byooviz-first-ophthalmology-biosimilar-launches-in-us
3. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal).2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
4. GaBI Online - Generics and Biosimilars Initiative. Canada approves ranibizumab biosimilar Byooviz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Mar 31]. Available from:
www.gabionline.net/biosimilars/news/canada-approves-ranibizumab-biosimilar-byooviz
5. BYOOVIZ™. Canadian Product Monograph. Available from: www.biogen.ca/products/BYOOVIZ_PM_EN
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 25]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 31]. Available from:
www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
8. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar pegfilgrastim Stimufend [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 31]. Available from:
www.gabionline.net/biosimilars/news/fda-approves-biosimilar-pegfilgrastim-stimufend
9. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 31]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
10. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of teriparatide and pegfilgrastim biosimilars[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 31]. Available from:
www.gabionline.net/biosimilars/news/ema-recommends-approval-of-teriparatide-and-pegfilgrastim-biosimilars

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