The Honorable Rick Scott
Office of the Governor
State of Florida 400 S. Monroe St.
Tallahassee, FL 32399-0001
Dear Governor Scott:
On behalf of the Biotechnology Industry Organization (“BIO”) and our more than 1,100 innovative member-companies world-wide, I am writing this letter urging you to sign House Bill 365 – a bill related to the substitution of biologic and biosimilar medicines – which recently passed out of the Legislature. House Bill 365, while not including all 5 of BIO’s own Principles on Biologic Product Substitution, is a significant step in recognizing the important and very complex role biologic medicines play in the future of healthcare and chronic disease management. BIO believes that this legislation represents a necessary measure to ensure that patients remain in control of their medical treatment decision-making as the market for complex biologics evolves over the next several years. What is more, we believe the policies underlying this legislation attempt to strike the appropriate balance of transparency and access that will ensure continued growth of an innovative and competitive bioscience industry in Florida as well as the rest of the United States.
Biologics are very complex medicines. Unlike traditional “small molecule” drugs, biologics are not chemically synthesized but, rather, are manufactured from living cells and tissues using a highly controlled process. Each resulting biologic therapy is complex and unique, and in many cases cannot be fully characterized by current scientific tools. As a result, even minor differences in manufacturing processes can cause variations in the end product. Consequently, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same.
Biosimilars are biologic products manufactured with the goal of closely mirroring the composition and treatment profile of an innovator biologic product but are produced without access to the innovator’s proprietary manufacturing processes. The production of biosimilar products, therefore, will invariably lead to differences in composition compared to the original innovator biologic product. Simply put, generic copies cannot be made for biologics. Until the passage of the Affordable Care Act several years ago, there was no pathway for the development and approval of biosimilar products in the United States. Today, with the creation of such a pathway to be developed by the Federal Food and Drug Administration, patients and the healthcare system stand to benefit from additional avenues of scientific development that portent a renewed drive to develop additional and perhaps even more innovative biologic treatments. But, the regulation of these new products does not exist solely at the Federal level.
Generally speaking, current state pharmaceutical generic substitution laws were passed many years prior to the introduction of most biologic products and therefore could not have anticipated biological medicines. As a result, most state laws need to be updated to appropriately address the commercialization and distribution of new biologic products and their biosimilar competitors, which are set to enter the marketplace over the next few years. And while 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 pharmacists when a different biologic product was prescribed is governed by state law. Thus, in recognition of this state-level authority over biosimilar and interchangeable biologic medicines, BIO and our collective membership has endorsed a set of core Principles1 that we believe should be considered by all states evaluating biologic substitution legislation.
Our membership believes that these Principles strike the appropriate balance of preserving the physician-patient relationship, protecting patients, maintaining incentives for innovation, and promoting a competitive market for biologic therapies. House Bill 365 as passed follows four of the five Principles outlined in BIO’s public policy document and we believe this is a significant step in ensuring appropriate access to Florida’s residents. Nevertheless, House Bill 365 does not contain a provision to ensure a physician is notified when a patient is switched between medicines in a pharmacy setting. We believe such transparency is an important component in the continuum of care necessary to ensure patients and physicians remain at the forefront of medical decision-making and we urge the State to reconsider adding this transparency provision as this market evolves.
I would both be happy to discuss this or any other issues with you further and I very much appreciate your consideration of BIO’s position.
John A. Murphy, III, Esq.
State Affairs, Health Policy
Biotechnology Industry Organization