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Maryland is the latest state to consider whether to include additional requirements for substitution of biological products.
As the industry waits for a final US regulatory pathway for biosimilars, state legislation affecting the dispensing of biosimilars is being debated in several states, once again drawing the battleground between the innovator-drug and generic-drug industries.
On Apr. 8, 2013, the state legislature of Maryland failed to move forward legislation that would have authorized pharmacists to substitute biosimilars for prescribed biological reference products only under specified circumstances. It also would have required pharmacists to give specified notices and record specified information if a pharmacist substituted an interchangeable biosimilar biological product for a prescribed biological reference product.
The legislation’s defeat was welcomed by the Generic Drug Pharmaceutical Association (GPhA). “We applaud the Maryland state legislature for making this wise decision,” said Ralph G. Neas, GPhA president and CEO, in an Apr. 10, 2013 statement. “...Maryland legislators know that passing laws requiring unnecessary notification and recordkeeping would create ‘red tape’ between patients and affordable medicines. We agree with the Maryland Department of Health and Mental hygiene, which in opposing this legislation, called it premature and unnecessary at this time.”
At issue in the defeated Maryland bill and in other state legislation is whether to include requirements for physicians and pharmacists on biological substitution. The Patient Protection and Affordable Care of 2010, the landmark healthcare reform package signed into law (Public Law 111-148) by President Barack Obama on March 23, 2010, authorized a regulatory pathway for biosimilars (1). In February 2012, FDA issued three draft guidances relating to biosimilars (2-4), but these guidances have not been finalized. The approval pathway, as established by the federal law, distinguishes between biologic products that are “biosimilar” to an innovator biologic, meaning they are “highly similar” to an innovator product, and biologic products that meet a heightened standard to be deemed “interchangeable” (5). Although FDA’s role in the approval of biologic and biosimilar medicines includes the designation of an interchangeable status, the policy on whether one biologic product may be substituted by dispensers when a different biologic product was prescribed is governed by state law (5), and it is that issue that has engendered the recent debate.
In January 2013, the Biotechnology Industry Organization (BIO) issued its “five principles on biologic substitution,” a framework that it recommends that states follow in adopting policy on biological substitution. The BIO principles call for substitution only when FDA has designated a biologic product as interchangeable, authorizes prescribing physicians to prevent substitution, requires both the prescribing physician and patient to be notified of substitution, and requires the pharmacist and the physician to keep records of the substitution.
Although Maryland did not move forward legislation that would have included such provisions, other states have passed such legislation or are considering it. In late March, North Dakota signed into law requirements related to the interchangeability of biological medicines. Virginia and Utah also have passed such legislation although the measures contain sunset provisions for when the measures would expire. Nine other states are considering legislation: California, Colorado, Illinois, Indiana, Florida, Massachusetts, Oregon, Pennsylvania, and Texas, according to GPhA. GPhA notes that Arizona, Mississippi, and Washington State have declined to pass legislation until FDA has issued final guidance and that the Arkansas state legislation has referred such legislation to a study committee for further consideration.
1. FDA, “Biosimilars,” www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/, accessed Apr. 10, 2013.
2. FDA, Draft Guidance for the Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Rockville, Md, Feb. 2012)
FDA, Draft Guidance for the Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (Rockville, Md, Feb. 2012).
4. FDA, Draft Guidance for the Industry: Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (Rockville, Md, Feb. 2012)
5. BIO, BIO Principles on Patient Safety in the Substitution of Biologic Products (Washington, DC, Jan. 24, 2013).