Pharma sector unimpressed with latest US biosimilars proposal

Kevin Grogan writes, Another bill has been introduced on biosimilars in the USA, this time by a bipartisan group of senators, which would give branded biologics just five years of market exclusivity. The proposed legislation has been put forward by Senators Chuck Schumer, Sherrod Brown, Jeanne Shaheen and Debbie Stabenow (all Democrats), plus Susan Collins, Mel Martinez and David Vitter (Republicans). It claims that the five-year limit, and up to an additional three years to cover modifications, will give patients quicker access to cheaper drugs.

Sen Schumer said "it's past time we created a way for generic versions of these expensive drugs to come to market". He added that "we have a bipartisan plan that we know consumers will support and we believe the president will too”.

The legislation, which is similar to a bill introduced earlier this month by Rep Henry Waxman (Democrat), would also require companies that want to make generic versions of biologics to pay a user fee to the US Food and Drug Administration. However the response from the pharmaceutical industry has been less than positive.

The Pharmaceutical Research and Manufacturers of America does not like the look of this latest bill, nor indeed the Waxman effort, saying that such a shortened period of exclusivity would discourage investment in drug development. "Developing biologic cures is a complex and difficult undertaking,” the association said, and “Congress needs to approach any changes in this arena carefully."

Even less pleased is the Biotechnology Industry Organisation. Its chief executive, Jim Greenwood, said that “while well-intentioned”, the bill follows Waxman’s proposal “through the looking glass to a world of biosimilars that would jeopardise patient safety and undermine future medical breakthroughs”.

He added any legislation should mandate that FDA approval of a biosimilar include clinical data demonstrating its “safety, purity and potency. Yet this bill includes language that would discourage the FDA from conducting certain clinical trials”. Mr Greenwood claimed that the bill “unfairly tilts the playing field toward biosimilars manufacturers” and a successful pathway “must strike the right balance in ensuring patient safety and providing fair, responsible incentives for continued biotech research”. The latest bill “fails to meet this reasonable metric”, he concluded.

PhRMA and BIO prefer a separate bill that was introduced last week by Democrats Anna Eshoo and Jay Inslee and Republican Joe Barton. That would offer all new biological drugs a base period of 12 years’ data protection, with the right to obtain an additional two years once a further indication for use of the product is approved by the FDA.

However the Generic Pharmaceutical Association is all for the latest bipartisan bill. Its chief executive Kathleen Jaeger said that the proposed legislation “demonstrates that life-saving biogenerics can get to patients in need sooner rather than later while also fostering competition to drive pharmaceutical innovation”.

She added that "it's time to enact legislation that gives the FDA the authority and flexibility to create a workable biogenerics approval pathway that upholds their gold standard of ensuring safety and quality”. Ms Jaeger concluded by saying that “we don't need a pathway that's so filled with roadblocks that it is merely an empty promise for patients”.

For more discussion on biosimilars, please join our Future of BioPharma LinkedIn group.

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