ABLE questions Indian approval of Cipla biosimilar
India's Association of Biotechnology Led Enterprises sent a letter to the Drug Controller General of India (DCGI) asking whether the approval of biosimilar Etacept from Cipla Ltd. (Mumbai, India) was based on India's Guidelines on Similar Biologics. Cipla launched Etacept -- a biosimilar version of autoimmune drug Enbrel etanercept from Pfizer Inc. (NYSE:PFE) and Amgen Inc. (NASDAQ:AMGN) -- in India in April to treat rheumatic disorders like rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic RA and psoriatic arthritis. The guidelines require the comparison of the quality, pharmacokinetics, safety and efficacy of a biosimilar vs. the innovator product for approval.
ABLE President P. M. Murali noted that Etacept is manufactured by a Chinese company and the Clinical Trial Registry of India (CTRI) website lists only one trial for Etacept -- an open label, non-comparative study in moderate to severe RA. Murali said the trade group is thus seeking "clarification from DCGI if any additional comparator studies other than those listed in CTRI were conducted in India to support the approval in accordance" with the guidelines. Cipla and the DCGI could not be reached for comment. ...