Statement by Ralph G. Neas, President and CEO, GPhA, Regarding H.B. 3734 in Massachusetts

Published Online: Tuesday, June 24, 2014
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PRESS RELEASE

June 24, 2014-- “GPhA applauds the Massachusetts state legislature for passing legislation allowing interchangeable biologics to be automatically substituted at the pharmacy. Laws that avoid unnecessary requirements around these new medicines not only increase patient access, but also will enable public and private payors to achieve significant savings by facilitating substitution of interchangeable biologics for more expensive versions. Massachusetts provides a compelling example of policy that embraces a practical approach.

As we get closer to the point when patients across the U.S. will be able to access these safe alternatives to costly brand name biologics, GPhA continues to support legislation that does not add burdens to current pharmacy practice and upholds the intent of the Biologics Price Competition and Innovation Act (BPCIA).”
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GPhA has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines. Indeed, Express Scripts projects savings of $250 billion in 10 years should only the 11 likeliest biosimilars enter the market.
Pharmacists will play key role in bringing biosimilar medications to US markets, both before the therapies receive FDA approval and after they become available.
“GPhA applauds FDA for taking helpful steps to address, and hopefully limit, scenarios in which some brand drug companies misuse Risk Evaluation and Mitigation Strategies programs to thwart competition from more affordable generic drugs. The ongoing abuse of REMS and REMS-like programs costs the American health system and its patients $5.4 billion annually, according to a study conducted by Matrix Global Advisors. Interestingly, as the United States market readies for biosimilars, this same study identifies $140 million in lost savings that would occur for every $1 billion in biologics sales.
Baxter International has submitted a biologics license application to the FDA for its investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on antihemophilic factor.
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