A missing link in the biosimilar regulatory framework of US could delay and wipe off potential earnings worth billions of dollars from the kitty of Indias generic drugs industry. The US subsidiaries of Ranbaxy, Sun Pharma, Dr Reddys, Glenmark, Strides, Cadila Healthcare and Ind Swift Labs have lodged a protest with the US Food and Drug Administration (USFDA) opposing a clause that would prevent pharma firms from filing new drug applications for the generic versions of biological drugs with the US drug regulator in the 12 years after an original branded drug is first approved for marketing.
In a letter to FDA commissioner Margaret Hamburg, the generic pharma association, of which these Indian drugmakers are members, has pleaded: If the legislation is interpreted to prevent biosimilar filings for 12 years, consumers will have to endure an unknown period of delay of FDA review and approval that could stretch far beyond the 12-year total that was set in the legislation.
The US Congress finalised a law last year to put in place the regulatory framework for biogenerics. However, there is an ambiguity over whether the data exclusivity is just 4 years or 12 years. During the period of data exclusivity, the regulator is not supposed to disclose or rely on the originator data for clearing generic applications.
While it is amply clear that of the 12 years of exclusivity allowed to the innovator company for an original biological drug, market as well as data exclusivity would be granted for the first four years, it is not very clear whether the subsequent eight years of exclusivity refers to market exclusivity or data exclusivity.
How the US FDA finally interprets the matter will have an enduring impact on how the biological drug market shapes up in the world's largest drug market. If the FDA concludes that the debated eight-year period is only 'market exclusivity' for the innovator company, the data on drug would be available to generic firms enabling them to file new drug applications during that period, which could translate into faster launch of cheaper generic version of original biological drugs. However, if the FDA concludes that the debated period pertains to 'data exclusivity', it would be practically unworkable for the generic firms to file a new drug application for biosimilars during the period, substantially delaying launch of generic versions.
We support the objections that have been raised by the generic companies in