Lobby fears norms violation in Cipla’s biosimilar drug

Source: The Economic Times

May 14,2013

MUMBAI: A lobby group of biotech drug companies in India has raised concerns about the approval of Cipla’s first biosimilar drug Etanercept, used for the treatment ofrheumatic disorders.

The Association of Biotechlogy Led Enterprises (ABLE) fears that Cipla may not have followed prescribed norms while launching the drug, which is sold under the Etacept brand name here. Biosimilar drugs are generic version of biologic drugs, whose active ingredients are derived from living organisms.

In a letter to the drug controller of India, ABLE’s president P Murali has asked the regulator to clarify if Cipla has followed the regulatory requirements that are part of the Guidelines on Similar Biologics. ABLE has raised questions on whether Cipla has complied with norms of selection for reference products, manufacturing process, quality-based considerations and clinical trial requirements.

“All biosimilar players in India are following the Guidelines on Similar Biologics as part of the regulatory requirement and we are hopeful that the application for biosimilar Etanercept has also satisfied the same,” Murali wrote to the drug controller in a letter, which ET has access to.

“It would be truly unfair if a different yardstick has been followed for approval of this biosimilar Etanercept,” he added.

A Cipla official, however, has rubbished ABLE’s contentions, maintaining that the company followed the rule book while launching the drug. “We have not flouted any norms,” said a top Cipla official who did not wish to be quoted since he’s not authorised to speak to the media.

One of the biggest worries for the association is the fact that Cipla has sourced the drug from its Chinese partner, and people from the biotech industry believe that while sourcing it, Cipla may not have followed certain norms. “These are Chinese products marketed in India, and it looks like there has not been any comparative study or vetting done for this product,” said an MD of a large biotech drug company, who did not wish to be quoted.

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