On December 10, 2013, the Federal Trade Commission ("FTC") will host a Workshop on the Competitive Impacts of State Regulations and Naming Conventions Concerning Follow-on Biologics. FDA has yet to receive its first biosimilar application filed under the Biologics Price Competition and Innovation Act of 2010 ("BPCIA"). Despite this, the FTC believes that some state legislatures have already passed laws that may affect substitution of biosimilars for their referenced innovator biologic products. As a result, the FTC is concerned that these laws may deter the development of biosimilars and raise the costs for consumers without biosimilar options.
FTC's Workshop plans to cover some of the following questions:
- How would the new state follow-on biologic substitution laws passed this year, or similar proposals pending in other states, affect the competition expected between or among biosimilar, interchangeable and reference biologic medicines?
- What are the rationales behind new state proposals and laws for regulating follow-on biologic substitution?
- What are the compliance costs associated with the new state requirements, and how are they likely to affect follow-on biologic competition?
- Would it benefit competition if the FDA published an authoritative listing of follow-on biologics that are biosimilar to, or interchangeable with, reference biologics? Would such a publication facilitate substitution?
The FTC's Federal Register Notice explained that it views biologic medicines as one of the most important pharmaceutical products that comprises the "fastest growing sector within pharmaceuticals" with treatments for critical diseases such as cancer, diabetes, and multiple sclerosis. Given the complexity of biologics, they are much more expensive to develop than small-molecule drugs, the Notice continues, and cost between $50,000 to $250,000 for one year of treatment. Currently, biologics represent about 25 percent of the $320 billion spent annually in the United States for pharmaceutical treatments. Even modest discounts in the price of biologics via biosimilars (or follow-on biologics, which appears to be FTC's preferred term), FTC believes, "could lead to significant consumer savings," as noted in its 2009 Report, Emerging Healthcare Issues: Follow-On Biologic Drug Competition ("FTC Report").
The FTC Report noted that a follow-on biologic's name could influence whether physicians and patients accepted follow-on biologics as a "substitute" for the referenced innovator's product. FDA has not determined how biosimilar or follow-on biologics will be commonly named via its active ingredient, in part because there is a concern that the name is part of "track and trace" systems to gather information such as adverse events to distinguish between innovator biologics and their follow-on counterparts. Some of the questions that FTC proposes to address in its Workshop related to these issues include:
- What has been learned from the experience under Hatch-Waxman about the incentives necessary to encourage physicians and patients to switch between branded and lower cost therapeutically substitutable products? Do naming and name changes affect switching? If so, how?
- How do the European Medicines Agency ("EMA") and other regulatory authorities comparable to the FDA handle the names of FOBs?
- As a prefix or suffix, such as "ado" or "TBO", has been attached to the nonproprietary names of several biologic products licensed under a stand-alone biologic license application. How does the use of such prefixes affect the inclusion of that product in third-party publications, compendia references, and health information systems, such as electronic health records and prescription processing systems?
- How does the use of certain identifiers, such as National Drug Codes, brand names, or nonproprietary names, work with existing adverse event reporting, track and trace, or other pharmacovigilance systems?
- With respect to prescription drugs, does the use of nonproprietary names globally contribute to or detract from competition and consumer protection? Do any studies exist to show increased or decreased consumer benefits or harms, due to changes in names or naming conventions?
FTC said the event is open to the public and will be simulcast as a webcast on the FTC's site. FTC will be accepting public comments until March 1, 2014. Interestingly, the posted agenda does not include any speakers from FDA but does include a former FDA employee, Emily Shacter, Ph.D., who is now an independent consultant for ThinkFDA, LLC. Shacter was formerly was Chief, Laboratory of Biochemistry, Center for Drug Evaluation and Research, Office of Biotechnology Products, Division of Therapeutic Proteins at FDA.