Congress Proposes Biosimilars Pathway

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ePT--the Electronic Newsletter of Pharmaceutical Technology

US Representatives Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced legislation this month week to create a regulatory pathway for biosimilars, or follow-on biologics.

Washington, DC (Mar. 27)-US Representatives Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced legislation this month week to create a regulatory pathway for biosimilars, or follow-on biologics. The so-called Pathway for Biosimilars Act would allow the US Food and Drug Administration to determine “whether the biosimilar is interchangeable with the reference product, and gives the FDA the flexibility to determine what clinical testing-if any-is required for approval,” according to a release from Rep. Eschoo. In addition, the act would provide 12 years of data exclusivity and establish a process for resolution of patent disputes prior to the time the biosimilar enters the market.

Although the Hatch–Waxman Act established a pathway for conventional follow-on drugs to be approved by FDA in 1984, the act does not apply to biologics. The challenges are considered to be greater with biologics in terms of documenting comparability and safety of large molecules, but scientists now feel they have the technology to do so. (Read more about the history of follow-on biologics).

In addition, because many biotechnology patents are starting to expire, many feel that now is the time to provide the pathway for biosimilars to reach the market. An additional goal behind the Pathway for Biosimilars Act is to “promote competition and lower prices, and protect patient safety, drug efficacy, and sound science,” said Rep. Eshoo in the release. “The most exciting developments in modern medical science are occurring in the field of biotechnology, and this legislation will ensure that the amazing cures and treatments biotech delivers today will continue and more patients will have access to these revolutionary therapies.”

There is concern over the Congressional proposal, however. The Generic Pharmaceutical Association (GPhA), for example, feels the act provides a pathway “to the wrong destination for patients in need of safe and affordable biogenerics,” according to a statement from GPhA President and CEO Kathleen Jaeger. “This new bill, at best, is a disappointing distraction that does nothing to advance legislation. At worst, it’s a step backwards that puts brand company profits before patient needs. For a pathway to work, it must ensure patient access. Unfortunately, this new proposal creates a pathway filled with needless roadblocks to access.”


Jaeger and others are concerned that the data exclusivity period, coupled with standard patent protection time, is too long and will hamper further innovation. “It will be decades before patients have access to affordable biogeneric medicines,” she explained, proposing that industry and Congress work together to create a pathway that will balance innovation and consumer access as did the Hatch-Waxman Act 25 years ago.

Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood is in support of Rep. Eschoo and Barton’s proposal, but cautions industry on the use of biosimilars. “While this provision improves upon previous legislative proposals, we continue to believe that patients should not be given follow-on biologics unless expressly prescribed by a physician,” he wrote in a BIO press release.

Read the text of the proposed act