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Ranbaxy launches India’s first biosimilar of Infliximab drug, Infimab

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Pune (Dec. 01, 2014): Ranbaxy Laboratories Limited (Ranbaxy), one of India's largest pharmaceutical company, today announced the launch of InfimabTM (BOW015), the first *Remicade® (Infliximab) biosimilar  in India.  The product was launched at the Indian Rheumatology Association Conference (IRACON), in the presence of over a thousand rheumatologists and doctors from around the country.

InfimabTM, is being introduced in the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, Inc. a US and Swiss-based Biopharmaceutical Company focused on the global development and commercialization of biosimilar monoclonal antibodies. InfimabTM will be manufactured by Reliance Life Sciences at a facility in Mumbai. The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

InfimabTM marks Ranbaxy’s entry into mAb (Monoclonal Antibodies) biologics, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis.

Talking about the significance of the newly launched InfimabTM, Rajeev Sibal, Vice President & Country Head-India Region, Ranbaxy, said, “InfimabTM 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. It will be available in India at a very significant discount as compared to the innovator drug. More Indian patients will get the benefit of a world-class biologic treatment.”

Rheumatoid arthritis is one of the most common chronic inflammatory diseases that cause disability. The literature estimates a prevalence of 0.5% to 0.75% in India. To manage the disease, Indian rheumatologists are using Infliximab to treat only a select set of patients because it is very expensive.

Dr. Arvind Chopra, Consultant Rheumatologist, Pune who was also the Principal Investigator of Clinical Trial conducted in India with InfimabTM (BOW015), stated, “There has been an inordinate interest among the medical fraternity in India regarding the launch of InfimabTM as it is an affordable therapeutic alternative to Infliximab with equivalent clinical effectiveness. The availability of the new drug has widened our options to treat several forms of arthritis. This will increase patient access and many more Indian patients will benefit from this biologic treatment. The drug will not only be able to stop progression of rheumatoid arthritis but effectively control several of its complications that include bone damage, deformities and osteoporosis. InfimabTM also has an excellent treatment potential to treat other crippling painful arthritis like ankylosing spondylitis and psoriatic arthritis".

Amit Munshi, president and CEO of EPIRUS, stated, “We are delighted to partner with Ranbaxy to bring InfimabTM to India. InfimabTM represents an affordable solution for patients and may expand patient access to this important medicine”.

It is well established through studies that if a biologic treatment is started relatively early and patients adhere for the required duration as recommended by the physician, significant improvement in overall treatment outcome can be achieved.  Along with the affordable pricing of InfimabTM, Ranbaxy has launched RAISE (Rheumatoid Ailment Infimab Support Endeavor) a patient support program for improving patient awareness and compliance on therapy. With a similar clinical safety and efficacy to Remicade®, a reduced cost of therapy, and patient support program, InfimabTM may encourage more patients to initiate and continue treatment, thus potentially improving the overall treatment outcome.