Drug maker Cipla Ltd. has forayed into the biologics segment by launching its first biosimilar - Etanercept - which is meant for the treatment of rheumatic disorders.
Formed through a partnership alliance, the drug sold under the Etacept brand name will be manufactured by China-based Shanghai CP Guojian Pharmaceutical Co. and marketed by Cipla in India, the company said.
Rheumatic disorders are chronic inflammatory disorders affecting the joints, characterized by pain, redness, swelling and loss of function in several joints. It can lead to joint damage and deformities.
If left undiagnosed and untreated, this could lead to permanent disability and at times could lead to mortality. However, rheumatic disorders can be controlled by early diagnosis and treatment, the company's note explained.
Etacept is available as a powder to be given by subcutaneous injection, and is available with stockists across the country at Rs.6,150.
Etacept contains Etanercept, a biologic produced by recombinant DNA technology. Etacept (Etanercept) binds to TNF-a, a cytokine that plays a very important role in inflammation and joint damage in rheumatic disorders. It helps in modifying the course of the disease and prevents further damage to the joints.
Etacept (Etanercept) is approved in the management of rheumatic disorders like Rheumatoid Arthritis, Ankylosing Spondylitis, Juvenile Idiopathic Rheumatoid Arthritis and Psoriatic Arthritis, the company said.
Since its launch in 2006 in China by Shanghai CP Guojian Pharmaceutical Co, over 50,000 patients were treated with Etanercept. Clinical efficacy and safety of the drug were well established in Indian patients, Cipla said.
Cipla's Medical Director Jaideep Gogtay commented, "The higher cost of biologics has been a major hindrance, limiting its affordability and accessibility to millions of patients. We believe that introducing Etacept at a lower cost (30 percent lesser compared to the innovator) will enable access of this drug to a greater number of patients in India. This can be enhanced further if we consider the results of a recent study that showed in patients, who were successfully treated with Etanercept for six months, a 50 per cent reduced dose worked just as well as continuing the current dose."
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