Alteogen gains approval to start aflibercept biosimilar trial in Korea

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Alteogen gains approval to start aflibercept biosimilar trial in Korea

Biosimilares/Novedades | Posted 21/06/2019 0 Post your comment

South Korean biologicals company Alteogen announced on 22 May 2019 that it had gained approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a clinical trial for its aflibercept biosimilar, ALT‑L9.

Aflibercept is used to treat eye diseases, including neovascular age-related macular degeneration (AMD), macular oedema secondary to retinal vein occlusion, diabetic macular oedema, and diabetic retinopathy.

The phase I, randomized, double-blind trial will be conducted in one of the five major hospitals in Korea. It will evaluate the safety, efficacy and pharmacokinetics in patients with wet age-related macular degeneration in comparison to the originator biological Eylea.

Alteogen says that this ‘domestic clinical trial of Eylea biosimilar is the first in Korea, which shows our potential as the first runner’. The company also intends to initiate a phase III trial during 2019 ‘to build the foundation for entry into the global market including the US, Europe and Japan’. The company is also reportedly ‘receiving many inquiries regarding the technology transfer from global pharmaceutical companies around the world’.

Alteogen was granted a process patent for its method of producing an aflibercept biosimilar in January 2019. The company expects this patent to further strengthen its competitiveness in Eylea biosimilar development [1].

Other companies also working on aflibercept biosimilars include US generics giant Mylan and partner Momenta Pharmaceuticals [2], US firm Coherus and Germany-based Formycon/Santo Holding.

References
1. GaBI Online - Generics and Biosimilars Initiative. Alteogen wins process patent for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Pharma-News/Alteogen-wins-process-patent-for-aflibercept-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Mylan/Momenta announce development strategy for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/General/Mylan-Momenta-announce-development-strategy-for-aflibercept-biosimilar

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Source: Alteogen