18 Apr 2013, BioSpectrum Bureau , BioSpectrum
Mumbai: Cipla launched the first biosimilar of Etanercept in India under the brand name, Etacept, indicated for the treatment of rheumatic disorders. Etacept is manufactured by China-based Shanghai CP Guojian Pharmaceutical and will be marketed by Cipla in India. The introduction of Etacept signals Cipla's entry into the biologics segment. Clinical efficacy and the safety of the drug have also been well established in Indian patients.
Etacept contains Etanercept, a biologic produced by recombinant DNA technology. Etacept (Etanercept) binds to TNF-α, 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.
Currently there are disease modifying anti-rheumatic drugs (DMARD), which are considered to be the first line of treatment for rheumatic disorders. However, approximately 40 percent of the patients are not controlled on these drugs. In such cases, biologics like Etanercept play a significant role in controlling the disease activity and make a positive difference in the lives of these patients.
Etacept is available as a lyophilized powder to be given by subcutaneous injection. It is available with stockists across India at $123 (Rs6,150) 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 percent 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 percent reduced dose worked just as well as continuing the current dose."