Richmond to launch similar biologicals bevacizumab Yriviak and adalimumab Armixa

On 22 July 2024, the Argentina-based Laboratorios Richmond announced the launch of Yriviak, a bevacizumab similar biological, in Argentina. In the coming months, Richmond plans to launch their adalimumab similar biological, Armixa.

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A) [1].

Yriviak is Richmond's first product in the ophthalmological therapy area to receive approval from the National Administration of Medicines, Food and Medical Technology (Administración Nacional de Medicamentos, Alimentos y Tecnología, ANMAT) on 30 November 2023, and is the second bevacizumab similar biological from Richmond.

Yriviak is indicated for the treatment of adult patients with neovascular (exudative) age-related macular degeneration; and is available as an intravitreal injectable solution presented in a vial containing 5mg/0.2 mL of bevacizumab solution.

The originator product, Roche's Avastin (bevacizumab), was approved by the US Food and Drug Administration in February 2004 and by the European Medicines Agency in January 2005 [2].

On 19 March 2021, ANMAT approved Richmond’s first bevacizumab similar biological Zutrab, for the treatment of colon cancer, lung cancer and ovarian cancer [3]. Zutrab is a VEGF inhibitor and is available in vials of 100 mg/4 mL and 400 mg/16 mL.

Currently, there are four other bevacizumab similar biologicals/biosimilars approved in Argentina. They are: Bevax and Lumiere, both produced by Laboratorio Elea [4], Mvasi by Amgen, and Ziraveb by Pfizer.

Following Yriviak, ANMAT approved Richmond’s adalimumab similar biological Armixa on 6 December 2023. Until today, in addition to Armixa, there are three other adalimumab similar biologicals/biosimilars approved in Argentina. These are Pfizer’s Abrilada, Amgen’s Amgevita, and Biosidus’s Hyrimoz, which is manufacturered by Sandoz [5].

Adalimumab is a human monoclonal antibody treats autoimmune diseases including rheumatoid arthritis, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, and ulcerative colitis [6].

Argentina has experienced a notable increase in similar biologicals/biosimilars approvals in recent years.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that similar biologicals approved in Argentina might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related articles
Biosimilars approved in Argentina

Safety surveillance of bevacizumab biosimilar (Bevax) in Argentina

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 6]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Argentina approves bevacizumab similar biological medicine Zutrab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 6]. Available from: www.gabionline.net/biosimilars/news/richmond-to-launch-similar-biologicals-bevacizumab-yriviak-and-adalimumab-armixa
4. GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 6]. Available from: www.gabionline.net/biosimilars/general/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America
5. GaBI Online - Generics and Biosimilars Initiative. US and EC approvals for Hyrimoz, US approval for Udenyca [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 6]. Available from: www.gabionline.net/biosimilars/news/us-and-ec-approvals-for-hyrimoz-us-approval-for-udenyca-autoinjector
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Aug 6]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-adalimumab

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