GPhA Lends Support for State Legislation for Automatic Substitution of Interchangeable Biologics

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 12-15-2014 12:56


The Generic Pharmaceutical Association (GPhA) issued a statement to offer its support for compromised automatic substitution legislation on a state level. GPhA issued the statement in consideration of the upcoming 2015 legislative session in which many state legislatures are likely to consider legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. Such legislation must be in place to allow automatic substitution when the US Food and Drug Administration (FDA) approves the first interchangeable biologics in the US. For nearly three years, states have been considering different versions of automatic substitution legislation.

The compromise legislation was put forward by several GPhA members, and GPhA said it reflects the associaton's 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," said GPhA in a statement. "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 said it will continue to work closely with its members and partners in the supply chain to further improve the legislation and ensure that barriers to automatic substitution are not enacted.

Source: Generic Pharmaceutical Association


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