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New proposed bipartisan legislation would cut biologicals exclusivity to seven years Posted 05/08/2016

Back in 2009, President Barack Obama’s government pledged to reduce the cost of biosimilar drugs for consumers and the time taken for those drugs to reach market in an effort to cut healthcare spending, but little has been achieved to date.

At the end of June 2016, The Price Relief, Innovation and Competition for Essential Drugs (PRICED) Act was introduced in the House of Representatives and the Senate. This bipartisan move by two Democrats (US Representative Jan Schakowsky and US Senator Sherrod Brown) and senior Republican Senator, John McCain, proposes a reduction in the exclusivity period on biologicals from 12 years to seven years, as originally suggested by President Obama in 2009.

According to Senator Sherrod Brown, 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.’

The Act has garnered support and opposition in equal measures. In favour is the Generic Pharmaceutical Association, which believes that a reduction of the exclusivity period to seven years would ‘speed patient access to more affordable versions of some of the most expensive medicines’.

In opposition, the Biotechnology Innovation Organization believes the legislation to be 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.’ It also believes that prices would increase in the long term.

The bill has been referred to the House Committee on Energy and Commerce.

Democratic presidential candidate Hillary Clinton also proposes to cut exclusivity on biologicals to seven years and wants to give Medicare the power to negotiate prices. Republican candidate Donald Trump is championing cheaper online purchase of drugs from countries such as Canada and the UK.

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