Cipla Launches First Biosimilar of Etanercept in India for Rheumatic Disorders

Published on: April 18, 2013

Cipla has launched the first biosimilar of etanercept in India for the treatment of rheumatoid disorders. The product will be marketed under the brand name Etacept. The launch of Etacept marks Cipla's entry into the biologics market, offering a low-cost alternative to Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India.

"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 (of 30% lesser as compared to the innovator) will enable access of this drug to a greater number of patients in India," commented Dr Jaideep Gogtay, medical director of Cipla in a company’s press release.

Etacept contains the biologic etanercept, which is produced by recombinant DNA technology. The product, manufactured by China's Shanghai CP Guojian Pharmaceutical Co. Ltd., is available as a lyophilized powder for subcutaneous injection. Since its launch in China by Shanghai CP Guojian Pharmaceutical Co. Ltd. in 2006, more than 50 000 patients have been treated with etanercept. According to Cipla, the drug has demonstrated clinical efficacy and safety in Indian patients. A recent study showed that for patients who were successfully treated with etanercept for 6 months, a 50% reduction in dose provided the same benefit as continuing with the current dose.