India-based Ranbaxy Laboratories (Ranbaxy) announced on 1 December 2014 that it had launched its infliximab ‘similar biologic’, BOW015 in India. This is the first infliximab similar biologic to be launched in India.
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 is being manufactured by Reliance Life Sciences at a facility in Mumbai. The drug has been launched under the brand name Infimab and is being introduced to the Indian market through a licensing partnership with US-based biologicals company Epirus Biopharmaceuticals (Epirus).
Rheumatoid arthritis is one of the most common chronic inflammatory diseases causing disability and is estimated to have a prevalence of 0.5−0.75% in India. Infimab will be available in India at a significant discount compared to the originator drug. In order to increase patient awareness and compliance Ranbaxy has launched a support programme: RAISE (Rheumatoid Ailment Infimab Support Endeavor).
According to Mr Rajeev Sibal, Vice President and Country Head-India Region, Ranbaxy, ‘Infimab offers a new opportunity in the management of conditions like rheumatoid arthritis. The product has been developed as per global standards and delivers a similar clinical outcome to the innovator.’ Results from phase I and phase III clinical trial results have shown the ‘bioequivalence’ and ‘clinical comparability’ of BOW015 to Remicade [1-3].
The world’s first monoclonal antibody biosimilar Remsima/Inflectra (infliximab) was approved in Europe in September 2013 [4]. Since then South Korean biotechnology company Celltrion has also gained approval for Remsima in 50 countries worldwide, including South Korea [5], Colombia [6], Canada and Japan [7]. The company has also applied for approval of Remsima in the US via the biosimilars pathway [8].
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.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase I data for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-data-for-infliximab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III data for Epirus infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-data-for-Epirus-infliximab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab comparable to Remicade [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-infliximab-comparable-to-Remicade
4. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea
6. GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab receives approval in Japan and Turkey [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-receives-approval-in-Japan-and-Turkey
8. GaBI Online - Generics and Biosimilars Initiative. FDA receives application for monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-receives-application-for-monoclonal-antibody-biosimilar
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