Law, Technology & Arts Blog

Will the 2014 Washington State Legislative Session Involve Biologics and Biosimilars?

Posted in Government and Regulation by LTA-Editor on January 13, 2014
Biologics

Photo Cred: Forbes.com

By Caitlin Forsyth

The Washington State Legislature convenes for its regular session next Monday, January 13. While our legislators will consider a multitude of issues important to the continued strength and health of the state, it will likely take up issues of special importance to Washington’s unique and fast-growing life sciences industry.

The Washington Biotechnology & Biomedical Association (WBBA) is a nonprofit trade association that serves Washington’s booming life sciences industry. Members of WBBA include organizations engaged in the research and development of life science technologies, including such well-known companies as BioRad and Amgen. WBBA’s mission is “to support and help to grow Washington State’s life science ecosystem.” One way WBBA accomplishes its mission is through legislative advocacy.

One of WBBA’s advocacy priorities for the upcoming legislative session is to convince state legislators to update Washington law to allow for the substitution of biosimilars for name-brand biologics, analogous to the common practice of substituting generics for name-brand chemical pharmaceuticals. Biologic drugs are large, complex molecules that pose unique patient safety issues that are not otherwise presented by chemical pharmaceuticals. The inherent complexity of biologics and their manufacture can create potential differences across biosimilar versions of the original product. Because of the differences in production as well as the unique cellular source of these drugs, it is nearly impossible to make truly identical copies of a protein using two different cell production lines. This makes both originator and biosimilar biologic drug production much more challenging than small molecular, generic chemical drug production.

The reason that the use of biosimilars in place of name-brand biologics is not an open-and-shut issue like the use of generics in place of name-brand chemical drugs is because biologics pose immunogenicity problems. Immunogenicity is the potential for a biologic to induce an adverse immunologic reaction. These severe reactions are difficult to predict. The human immune response to a biologic product is difficult to predict generally, and this is even more difficult in the face of changes to the manufacturing processes for biologics and biosimilars.

While biosimilars may pose patient safety concerns, the use of biosimilars could also save a lot of healthcare dollars—an issue especially important in this age of skyrocketing healthcare costs and the push for cost reform. For example, a year’s worth of a breast cancer–fighting biologic costs more than $40,000 and a year’s supply of a biologic to treat a rare disorder costs over $150,000. The use of biosimilars of these biologics could save consumers about $1 billion per year.

Last year, the Washington Legislature considered this issue for the first time. During the February 22 Health Care and Wellness Committee meeting, the Committee held a public hearing on HB 1528 (concerning the prescription of biological products and interchangeable biosimilar products). HB 1528 authorized “biosimilar products to be substituted in the place of a biological product if the United States Food and Drug Association has determined that the biosimilar product is interchangeable with the biological product.” That is, when filling a prescription, a pharmacist would have been allowed to substitute a biosimilar product in the place of a name-brand biologic. The general authorization of substitution was subject to a number of exceptions. The bill, however, was offered for public hearing on the last day of meeting for the Health Care and Wellness Committee, effectively rendering the bill unable to move past the committee stage, as same-day executive action on the bill would have been infeasible.

While political reasons may have motivated the chair to entertain a public hearing on the bill even though there was no chance of the bill being passed, the fact that the bill was even up for public hearing at all is promising for Washington’s biosimilar producers. Members of the Committee seemed actively engaged in and concerned about the issue during the bill’s public hearing. One member, in responding to an Amgen representative’s testimony about the European Union’s (EU) 2006 approval of biosimilars, asked whether the EU had conducted any studies on adverse events resulting from biosimilar use. Many other members asked similar questions. The members’ willingness to ask questions, and specific questions at that, even though no executive action was to be taken, is likely indicative of their willingness to entertain the idea further. Only time and the progression of the 2014 legislative session, however, will prove or disprove this prediction.

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