What is the role of the States in regulating biosimilars?
Manufacturers of generics must prove to the FDA that their version is “bioequivalent” to the original drug – that is, it has the same safety, purity and potency as the innovator. Once deemed “bioequivalent” to its trade-name counterpart, a generic may be interchanged with its innovator.
Interchangeability is inherently more difficult to establish for biosimilars than it is for generic versions of chemical drugs because biosimilars products can never be exact copies of innovator biologics.
The substitution of generics drugs for branded drugs is a practice regulated by the individual states. Unless physicians have specifically indicated on the prescription that the “brand drug” be dispensed, pharmacists must follow state laws regarding substitution.
Because of the ambiguity in the federal statute – specifically, the use of “may” – states will have to determine what an FDA determination of interchangeability will mean within a state substitution policy, and the role of the prescribing physician in that process.
As reference, most U.S. states do not permit therapeutic substitution at all, or in states that do, it is limited to a very narrow set of disease states or therapeutic product classes. Though the practice of biologic substitution by a pharmacist without a physician’s consent has been rejected in more than half of the EU member states (including France, Germany, the United Kingdom, Italy and Spain), the US is taking a different approach.
Virginia House of Delegates Bill on Interchangeable Biosimilars
To show support of Virginia House Bill 1422 on interchangeable biosimilar biological products, which is consistent with ASBM’s principles on interchangeability, Dr. Dolinar and ASBM members sent letters to members of the House Committee on Health, Welfare and Institutions. HB 1422 limits automatic substitution of biologics to those deemed interchangeable by FDA and requires physician notification in a reasonable time frame following substitution.
GHLF Virginia House Biosimilars Letter
Kidney Cancer Association Letter
American Academy of Dermatology Letter
Virginia Senate Bill on Interchangeability
ASBM and several of our members signed onto a letter opposing Senate Bill 1285, urging the Senate to adopt all of all patient protections that the House included in their HB 1422, especially that:
- Substitutions for biologic medicines only be allowed in cases in which the Food and Drug Administration has certified that a biosimilar product is interchangeable.
- Substitutions for biologic medicines only be allowed in cases in which the Food and Drug Administration has certified that a biosimilar product is interchangeable.
- Records of biosimilar substitutions be kept for a period of no less than two years from the dispensing date.
North Dakota Senate Measure No. 2190
On January 21, 2013 Dr. Dolinar sent a letter of support on North Dakota Senate Bill 2190 on biosimilars interchangeability, which outlines that a pharmacy may substitute a biosimilar only if: the biosimilar has been determined by the FDA to be interchangeable with the prescribed product for the specified indicated use and the physician is notified within 24 hours of the substitution. Read the full bill here.
Indiana House Legislation on Interchangeability
ASBM and member organizations weighed in with support for Indiana House Bill 1315 on interchangeability, which aligns with ASBM’s principles. Read the bill here.
HealthHIV Letter on IN HB 1315
Colorado House Bill 1121
On Tuesday, February 12, the CO House Health, Insurance & Environment committee held a hearing on HB 1121, which ASBM and several member organization supported with letters. Allen Todd with Global Healthy Living Foundation testified on behalf of patients before the committee. Read his testimony here.
