WASHINGTON, DC (December 9, 2014) —
"As state legislatures prepare for their 2015 sessions, I am pleased to announce that 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.
The compromise legislation was put forward by several GPhA members and reflects our core principles: upholding the current pharmacy practice of automatic substitution; insisting on the science-based FDA determination of interchangeability; and treating all interchangeables and their corresponding brand biologics the same once an interchangeable is approved. The compromise language is a vast improvement over 2012 language that we strongly opposed, and which originally erected numerous barriers to the automatic substitution of interchangeable biologics. GPhA opposes notification of prescribers as a barrier to substitution. As reflected in the Biologic Price Competition and Innovation Act (BPCIA), once the Food and Drug Administration determines a biosimilar is interchangeable with its reference product, patients can be assured that the biosimilar will provide the same therapeutic result as the reference product against which it was evaluated.
In light of the overwhelming progress it represents – and to ensure that patients have the earliest access to more affordable biologics – GPhA will support the compromise language, which provides a framework to advance automatic substitution. Such legislation is likely to be introduced in many states in the upcoming 2015 legislative session, and it must be in place to allow automatic substitution when the FDA approves the first interchangeable biologics in this country.
GPhA will continue to work closely with our members and partners in the supply chain to further improve the legislation and ensure that barriers to automatic substitution are not enacted. Today's announcement represents a major advance in that direction. By paving the way for broader access to these life-changing medicines and the savings they provide, we are striking a blow for patients and the healthcare system. This is a victory for the same values of access and fairness that GPhA strives for in all our efforts."
Background: Biosimilars and State Legislation
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.