Infliximab is a monoclonal antibody, which is used to treat ankylosing spondylitis, Crohn’s disease, psoriatic arthritis and psoriasis, rheumatoid arthritis, ulcerative colitis. Johnson & Johnson’s originator version, Remicade, had sales of US$8 billion in 2010.

The clinical trial of Reliance Life Sciences ‘similar biologic’ monoclonal antibody has been approved by the Drug Controller General of India and will be carried out in 189 patients at multiple centres in India, including Bangalore, Chennai, Hyderabad, New Delhi and Pune.

It is hoped that the ‘similar biologic’ will bring down the cost of treatment for rheumatoid arthritis in India by 50%. Currently, a course of four injections of the originator drug costs Rs 2-3 lakh (Euros 2,900–4,300), a price that is out of reach for many patients in India. In fact, Dr K Mahendranath, former President of the Indian Rheumatology Association, told The Indian Express that access to biologicals has been restricted due to their exorbitant cost.

The prevalence of clinical rheumatoid arthritis in India is between 0.45—0.68%, according to a recent report by WHO. This translates into more than 10 million rheumatoid arthritis patients with aggressive crippling disease, according to Dr Arvind Chopra, Director at the Centre for Rheumatic Diseases.

Dr Chopra, who is also one of the investigators in the clinical trial, told The Indian Express that with the patents of biological drugs beginning to expire in the next two to three years, several manufacturers have geared up for the next big thing—‘similar biologics’—as they promise a potential for more affordable therapy.

Reliance Life Sciences already markets seven ‘similar biologics’ in India and overseas: ReliFeron (interferon alpha), ReliPoietin (erythropoietin), ReliGrast (Granulocyte colony-stimulating factor), MIRel (reteplase - tissue plasminogen activator), FostiRel (follicle stimulating hormone), ReliBeta (interferon beta-1a) and ChorioRel (chorionic gonadotrophin hormone r-hCG) [1].

The India-based company also has a UK-based subsidiary (Reliance GeneMedix) with a manufacturing facility in Ireland, which is involved in developing biosimilars for the European market.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-and-marketed-in-India

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