Cipla has launched the first biosimilar of Pfizer and Amgen’s rheumatic disorder blockbuster Enbrel in India.
The company will sell its version of Enbrel (etanercept) under the brand name Etacept which will be manufactured by China’s Shanghai CP Guojian Pharmaceutical Co. The drug signals Cipla’s entry into the biologic segment, it said, “offering an option to patients suffering from rheumatic disorders at a lower cost”.
The Mumbai-based group’s medical director Jaideep Gogtay said “the higher cost of biologics has been a major hindrance, limiting its affordability and accessibility to millions of patients”. He added that introducing Etacept at a lower cost (at 6,150 rupees, 30% less than the innovator product) “will enable access of this drug to a greater number of patients in India”.
The recommended dose for adults is 25 mg twice-weekly by subcutaneous injection. Cipla noted that disease-modifying anti-rheumatic drugs (DMARDS) are considered to be the first line of treatment for rheumatic disorders but 40% of patients are not controlled on these therapies.
Strides Arcolab biosimilar JV
Meantime, a unit of India’s Strides Arcolab, Agila Biotech has entered into a joint venture with the USA’s Pfenex to develop six biosimilars for the global market.
Agila Biotech, which will have a 51% stake in the JV, said the partnership combines Pfenex’ “industry-leading expertise in strain engineering and process development” with its own biologics manufacturing and clinical development excellence. The lead product will be a biosimilar of Bayer’s multiple sclerosis drug Betaseron (interferon beta-1b) and human clinical trials will begin before the end of the year.
Agila chief executive Anand Iyer said that “a successful foray into the biologics space” for companies like his “hinge not only on building a state-of-the-art infrastructure and strong technical foundation, but also on creative partnerships” such as the one with Pfenex. He added that “this will allow us to not only leverage time and cost advantage of developing products in India and Malaysia but also serve as a gateway to a vast region” in Asia which is “currently underserved as a result of the lack of high-quality, cost-effective biologics”.
The products will be manufactured at Agila’s state-of-the-art facility being built with partner Bio-XCell at Nusajaya, Johor, Malaysia.
