Senators, U.S. Rep introduce bill to shorten length of biologics exclusivity

WASHINGTON — U.S. Rep. Jan Schakowsky and Sens. Sherrod Brown and John McCain on Thursday introduced a piece of legislation aimed at shortening the period of exclusivity for brand-name biologics products. The Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act would amend the Public Health Service act to change the exclusivity period from 12 years to seven years. 

 

Brown said that the bill would “allow for more robust competition in the biologics market and provide for more new, equally effective biosimilars which will help provide more options for consumers and drive down prices.” According to an October 2015 report from the Government Accountability Office, Medicare Part B spent $4.418 billion on the highest-cost newly approved biologics in 2013. 

 

But the Biotechnology Innovation Organization, which represents biotechnology companies and related organizations, thinks the bill will harm biotech companies looking for new cures.

 

“BIO strongly opposes H.R. 5573 and its companion bill in the Senate,” BIO SVP federal government relations Jeanne Haggerty said. “This legislation would disrupt the careful balance, created by Congress with broad, bipartisan support in the Biologics Price Competition and Innovation Act (BPCIA), between the need to encourage investment in innovative, groundbreaking biological therapies and the desire to ensure that patients have increased choices offered by biosimilar products after a reasonable period of exclusivity for the innovator product. 

 

Haggerty said the 12-year exclusivity period is “an essential incentive for the huge risks associated with biotechnology investment,” as many biotech companies rely largely on venture capital to fund their innovations.

 

“Undermining investment in these companies means undermining investment in the next biomedical breakthroughs for patients,” she said. “This legislation is a short-sighted attempt to undercut the critical work that innovator companies are doing and would, if enacted, deprive patients of many new treatments and cures in the future.”

 

Schakowsky’s bill has been referred to the House Committee on Energy and Commerce.