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Infliximab ‘similar biologic’ receives Indian approval Posted 03/10/2014

US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 15 September 2014 that it had received final marketing and manufacturing approvals for its infliximab similar biologic, BOW015, from the Drug Controller General of India (DCGI).

BOW015 is a similar biologic of Johnson & Johnson’s blockbuster drug Remicade, which was approved by the European Medicines Agency (EMA) in August 1999. Remicade is indicated for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

BOW015 will be manufactured by Reliance Life Sciences at a facility in Mumbai, India.

Epirus and its commercialization partner Ranbaxy Laboratories (Ranbaxy) expect to launch the drug under the brand name Infimab, by the first quarter of 2015. The two companies signed a licensing agreement for BOW015 in January 2013 [1]. Under the terms of the agreement, Epirus will develop and supply BOW015, and Ranbaxy will register and commercialize BOW015 in India as well as in other territories in Southeast Asia, North Africa and selected other markets.

Results from phase I and phase III clinical trial results have shown the ‘bioequivalence’ and ‘clinical comparability’ of BOW015 to Remicade [2-4].

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 EU. 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.

References
1. GaBI Online - Generics and Biosimilars Initiative. Epirus and Ranbaxy sign agreement for infliximab 'similar biologic' [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/News/Epirus-and-Ranbaxy-sign-agreement-for-infliximab-similar-biologic 
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase I data for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-data-for-infliximab-biosimilar 
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase III data for Epirus infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-data-for-Epirus-infliximab-biosimilar 
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab comparable to Remicade [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-infliximab-comparable-to-Remicade 

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Source: Epirus

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