Legislation introduced this week in the US Congress would give innovative biological drugs 14 years’ market exclusivity before generic versions could come onto the market.

The Pathway for Biosimilars Act, introduced into the House on Tuesday, 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 Food and Drug Administration (FDA).

The bill’s lead sponsors, Democrats Anna Eshoo and Jay Inslee and Republican Joe Barton, said it would create a process for approval of biosimilars while protecting patient health and safety, lowering health care costs and providing adequate incentives for innovation.

Its provisions were welcomed by the research-based industry, with Jim Greenwood, chief executive of the Biotechnology Industry Organization (BIO), describing it as “the right medicine for lowering costs, ensuring patient safety and providing fair, responsible incentives for continued biotech research into cures for diseases such as cancer, multiple sclerosis, Alzheimer’s and HIV/AIDS.” The bill provides patients with the right balance between innovation and competition and “will lead to real solutions for our nation’s health care challenges and provide real hope for patients,” he added.

Robert Armitage, senior vice president and general counsel at Eli Lilly & Co, described the Act as “a carefully considered, balanced approach to ensuring the promise of biotech medicine becomes a reality for patients."

But, according to Debra Barrett, senior vice president of government affairs at leading generics maker Teva, the bill “is clearly written to protect brand-name drugs and their innovators’ government-granted monopoly at the expense of access and innovation. This bill will dampen innovation and deny Americans access to more affordable healthcare,” she added.

The legislation was also attacked by the Generic Pharmaceutical Association (GPhA), which is backing another biogeneric pathway bill, the Promoting Innovation and Access to Life-Saving Medicine Act. This was introduced into the House of March 11 by a bipartisan group including Democrat Henry Waxman and would provide original biotech products with an average of just five years’ market exclusivity.

The Eshoo-Inslee-Barton bill is “the wrong road for patients looking for safe and affordable biogeneric medicines, particularly during these difficult economic times. It is a long route filled with needless roadblocks that will keep patients from getting needed medicines in a timely manner,” said GPhA chief executive Kathleen Jaeger.

The Act would benefit brand companies only, by creating barriers including an “unprecedented and unjustifiable” 14 years of market exclusivity, she added. “Given that there is a minimal difference of less than eight months longer in the development of biopharmaceuticals when compared to traditional pharmaceuticals, there is little justification for excessively expanding exclusivity beyond the Hatch-Waxman model. Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines,” said Ms Jaeger.