The similar biologic has been approved by the Drug Controller General of India for the treatment of wet age-related macular degeneration (AMD), a common degenerative condition of the eyes in the elderly. It is also indicated for macular oedema following retinal vein occlusion, degenerative myopia and diabetes complications. The drug will be marketed under the brand name Razumab (ranibizumab).

Intas claims to be ‘the first company globally to develop and launch a biosimilar version of ranibizumab’. They add that Razumab ‘is manufactured under strict guidelines for sterile use in the eye’ and ‘is a 100% “Made in India” molecule’.

The originator product, blockbuster wet AMD treatment Lucentis (ranibizumab) from Novartis, was first approved globally in 2006/2007. Lucentis had estimated global sales of approximately US$4 billion in 2014. The patents on Lucentis expire in Europe in 2022 and in the US in June 2020 [1].

Razumab will be offered to patients at a discount of about 25% compared to the price of Lucentis in the country, which would lead to annual savings of about Rupees 35,000 for patients.

Razumab is the tenth similar biologic launched by Intas in India, and the company claims to have ‘by far the largest number of indigenously developed biosimilars’.

US-based injectables specialist Hospira and US biotechnology firm Pfenex are also working on a biosimilar candidate of ranibizumab (PF582) [1].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (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.

Related article
Biosimilars approved in Europe

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Hospira and Pfenex to collaborate on ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 26]. Available from: www.gabionline.net/Biosimilars/News/Hospira-and-Pfenex-to-collaborate-on-ranibizumab-biosimilar

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