Cipla, a leading generic pharmaceutical company in India has launched the first biosimilar of Etanercept in India; under the brand name ‘ETACEPT’ for the treatment of rheumatic disorders. Formed through a partnership alliance, ETACEPT is manufactured by a China-based company Shanghai CP Guojian Pharmaceutical, which will be marketed by Cipla in India. Cipla, of late, has been aggressively developing the product pipeline in emerging therapies like oncology, rheumatology, pulmonary arterial hypertension, hepatology etc. The introduction of ETACEPT now signals Cipla’s entry into the biologic segment and is expected to offer an option to the patients suffering from Rheumatic disorders at a lower cost.
Currently there are DMARDs (Disease modifying anti-rheumatic drugs) which are considered to be the first line of treatment for rheumatic disorders. However, approximately 40 per cent of the patients are not controlled on these drugs. In such cases, biologics like Etanercept is expected to play a significant role in controlling the disease activity and make a positive difference in the lives of these patients.
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 the 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.
A company release states that since its launch in 2006 in China by Shanghai CP Guojian Pharmaceutical, over 50,000 patients have been treated with Etanercept. Clinical efficacy and the safety of the drug have also been well established in Indian patients.
ETACEPT is available, as a lyophilized powder to be given by subcutaneous injection, with stockists across the country at Rs 6,150/- and the recommended dose for adults is 25mg twice weekly by subcutaneous injection.
Commenting on the launch of ETACEPT, Dr Jaideep Gogtay, Medical Director, Cipla said, “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 per cent lesser as 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.”
EP News Bureau – Mumbai