BIO, GPhA Offer Countervailing Views on Proposed Legislation for Biologics Exclusivity

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-28-2016 14:33


Industry group representing innovator drug companies and generic drug companies have taken opposite positions regarding proposed US legislation, H.R. 5573 and companion legislation in the Senate, which would amend the Public Health Service Act to shorten the exclusivity period for innovative biological products from 12 to 7 years. The data exclusivity provisions were enacted by the Biologics Price Competition and Innovation Act (BPCIA), which was part of healthcare reform signed into law by President Obama in March 2010. The BPCIA created an abbreviated pathway for regulatory approval of biologic medicinal products that are “biosimilar” to or “interchangeable” with an already FDA-approved biologic product.

On the innovator side, the Biotechnology Innovation Organization (BIO) issued a statement in opposition to the legislation.“BIO strongly opposes H.R. 5573 and its companion bill in the Senate. 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," said BIO Senior Vice President for Federal Government Relations Jeanne Haggerty in a statement. "Data exclusivity of 12 years is an essential incentive for the huge risks associated with biotechnology investment. The majority of biotechnology companies are small, private start-ups, heavily reliant on venture capital investment. And these companies hold two-thirds of the industry’s innovative clinical pipeline. Undermining investment in these companies means undermining investment in the next biomedical breakthroughs for patients."

She continued. The legislative process that produced the current U.S. system was deliberate, thoughtful, and driven by rigorous analysis. The BPCIA received overwhelming support in Congress at the committee level and in both the full House and Senate. 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.”

On the generics side, the Generic Pharmaceutical Association issued a statement supporting the proposed legislation. "The Generic Pharmaceutical Association (GPhA) and its Biosimilars Council strongly support H.R. 5573 introduced this week by Sen. Sherrod Brown (D-OH) and Rep. Jan Schakowsky (D-IL)," said GPhA President and CEO Chip Davis. "The Price Relief, Innovation, and Competition for Essential Drugs (PRICED) Act will speed patient access to more affordable versions of some of the most expensive medicines by markedly reducing biologic exclusivity and increasing pharmaceutical competition, consistent with proposals in the President’s budget."

Source: BIO and GPhA


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