Bipartisan members of the US House Committee on Energy and Commerce yesterday introduced the Promoting Innovation and Access to Life-Saving Medicine Act, which would empower the Food and Drug Administration (FDA) to approve generic copies of biotechnology drugs.

The bill provides the FDA with authority to ensure that any approved copy of a biotech drug is just as safe and effective as the original product, and provides the makers of new biotech drugs ample incentives for continued innovation, say its authors, who include the Committee’s chairman, Democrat Henry Waxman. “The only way we can succeed in establishing robust competition for biotech drugs is with biosimilar drugs that doctors and patients know they can count on,” said Rep Waxman.

However, while the research-based industry has been calling for 14 years’ market exclusivity for their original products before copy versions could be launched, the bill gives just five years’ exclusivity for biologic drugs with a novel molecular structure. Orphan products for the treatment of rare diseases would have seven years’ exclusivity, but for straightforward reformulations the period would be up to three years.

Another of the bill’s sponsors, Republican Nathan Deal, pointed out that biologic drugs often cost on average 22 times more per daily dose than chemical medications, and the most expensive can cost well over $100,000 per year. “It is expected that approximately 50% of all drugs approved in 2010 will be a biopharmaceutical, a projection which only underscores the need for this legislation as the strain on state and federal governments grows. As the pharmaceutical market is further saturated by biologics, mechanisms must be put into place to promote competition and continued innovation,” he added.

The bill was welcomed by the Generic Pharmaceutical Association (GPhA), whose chief executive, Kathleen Jaeger, said: “during these difficult economic times, there must be increased urgency to support solutions that strengthen health care while reducing costs.” The bill “is the right solution for high quality care at affordable costs,” she added.

However, the Biotechnology Industry Association (BIO) said the bill “seeks to cut prices but instead cuts corners,” and would take patients and industry “down the wrong path.” Its passage would jeopardise the continued development of new breakthrough therapies and potential cures for debilitating diseases and also industry’s “ability to help meet President Obama’s call for a cure for cancer ‘within our time’ and help realise the promise of stem cell research,” warned BIO’s chief executive, Jim Greenwood.

“A pathway must recognize that biologics are much more complex than traditional pharmaceuticals and that the regulatory standard for approval of biosimilars will be based on similarity rather than sameness as is the case with traditional generic drugs,” he noted, adding: “we can take no short cuts to safety when it comes to biosimilars.”

- A companion bill is expected to be introduced in the Senate shortly.