Clinical trials for aflibercept biosimilars

Sandoz, the generics division of Novartis, has announced the start of a phase III clinical trial of its aflibercept (Eylea) biosimilar, a treatment for age-related macular degeneration. Clinical trials for a number of competitive biosimilars are also underway.

Aflibercept is a vascular endothelial growth factor to VEGF, inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema.

Neovascular (wet) age-related macular degeneration (AMD) accounts for 10% of all AMD cases and 90% of cases of blindness are caused by AMD.

Indications for aflibercept have also been expanded to other ophthalmological conditions, including diabetic macular oedema and diabetic retinopathy. Aflibercept works by binding to VEGF, preventing abnormal blood vessel growth in the eye. It has been sold under the brand name Eylea by originator company Regeneron Pharmaceuticals.

Sandoz announced at the start of May 2021 progress in the clinical development of its aflibercept biosimilar, stating that recruitment for a phase III clinical trial would begin enrolling shortly. The trial, named MYLIGHT, complements analytical, preclinical and other clinical studies and will confirm that the biosimilar has equivalent efficacy and comparable safety to the reference product in patients with neovascular AMD. It will include 460 patients across 20 different countries. Patients will be randomized to receive either biosimilar aflibercept or the reference drug for 48 weeks. The primary endpoint is improvement in visual acuity.

Florian Bieber, Global Head of Biopharmaceuticals Development at Sandoz, said: ‘Aflibercept is a key treatment in ophthalmology. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept. As with all our biosimilar programs, we aim to expand access to high-quality, more affordable biologicals.’

There are currently no aflibercept biosimilars available on the US market, although a number of companies are competing to be the first to reach the market as the patent on Eylea will expire in the US in 2028 (and in 2025 in Europe, where there are also no biosimilars available).

The Korean manufacturers Alteogen, Celltrion, Samsung Bioepis and Samchundang Pharm are all developing biosimilars. Samsung Bioepis announced plans for a phase III trial for its aflibercept biosimilar, SB15, including 446 patients [1]. Clinical trials will be conducted in 10 countries and completed by February 2022.

Celltrion has also began phase III trials of their biosimilar, CT-P4, with US and EU approval. The company plans to complete trials with 300 people by November 2021.

Alteogen’s is developing a biosimilar named ALT-L9 and has conducted phase I clinical trials at four major hospitals in South Korea [2]. It plans to commercialize the drug in Europe by 2025 using a subcutaneous injection method, which would avoid violating Eylea’s patent and allow earlier sale [3].

Samchundang Pharm, which is aiming at US and Japanese approval, has sped up phase III trials of its biosimilar SCD411. Clinical trials began in August 2020 and the company hopes to complete them in the second quarter of 2022. It also has a different method of formulation and can therefore bypass Eylea’s patent.

Outside of South Korea, US-based company Amgen is beginning a phase III trial for their aflibercept biosimilar [4]. The randomized phase III study will compare Amgen’s candidate aflibercept biosimilar, named ABP 938, to Eylea in 566 people. It will span 116 sites and is expected to complete in April 2022.

Phase I trials started for aflibercept and ustekinumab biosimilars

Biosimilars of aflibercept

LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. GaBI Online - Generics and Biosimilars Initiative. Phase III trial updates of Samsung Bioepis’ bevacizumab and aflibercept biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: https://www.gabionline.net/Biosimilars/Research/Phase-III-trial-updates-of-Samsung-Bioepis-bevacizumab-and-aflibercept-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Advances for Formycon and Alteogen’s eye disease biosimilar candidates [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: https://www.gabionline.net/Biosimilars/News/Advances-for-Formycon-and-Alteogen-s-eye-disease-biosimilar-candidates
3. GaBI Online - Generics and Biosimilars Initiative. Alteogen wins process patent for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: https://www.gabionline.net/Biosimilars/General/Alteogen-wins-process-patent-for-aflibercept-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Amgen starts phase III trial for aflibercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: https://www.gabionline.net/Biosimilars/News/Amgen-starts-phase-III-trial-for-aflibercept-biosimilar

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