US generics giant Mylan and partner Momenta Pharmaceuticals announced on 3 January 2017 their development strategy for their aflibercept biosimilar, M710.
The product is a proposed biosimilar of Regeneron’s wet age-related macular degeneration treatment, Eylea (aflibercept). Eylea is the market-leading vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema.
The companies’ plans for M710 include initiating a pivotal clinical trial in the first half of 2018. According to the joint press release, the trial will be a randomized, double-blind, active-control, multicentre study in patients with diabetic macular edema to compare the safety, efficacy and immunogenicity of M710 with Eylea.
Momenta is also developing M834, a proposed biosimilar to Orencia (abatacept) in collaboration with Mylan [1], and M923, a proposed biosimilar to Humira (adalimumab) [2].
Mylan is collaborating with Polish firm Mabion on a rituximab biosimilar (MabionCD20) [3]. The company is also collaborating with Indian firm Biocon on a pegfilgrastim biosimilar (MYL‑1401H) [4], a trastuzumab biosimilar (MYL‑1401O) [5], an insulin lispro biosimilar [6], and an insulin glargine biosimilar (MYL‑1501D) [7].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of abatacept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-abatacept
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin lispro [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-insulin-lispro
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin glargine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-insulin-glargine
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