Antitrust Law Daily Wrap Up, CONFERENCES: FTC workshop on biologic drugs to explore development and competition issues, (Nov 11, 2013)
By Linda O’Brien, J.D., LL.M.
The FTC will host a workshop on December 10, 2013, in Washington, D.C. to explore competition issues involving biologics and follow-on biologics. Announced in the FTC’s Federal Register notice, the workshop will focus on how state regulations and naming conventions may impact the development of, and competition for, follow-on biologics.
The Commission has sought to promote competition in the health care industry among pharmaceutical products. Facilitated by state automatic substitution laws, competition between brand-name drugs and lower cost generic alternatives has substantially reduced prescription drug prices. To encourage price competition and innovation in markets of biologics, in 2010, Congress passed the Biologics Price Competition and Innovation Act (BCPIA), which established an abbreviated regulatory pathway for the approval of follow-on biologics by the U.S. Food and Drug Administration (FDA).
Biologics comprise the fast-growing sector of pharmaceuticals and target difficult to treat diseases, such as cancer, diabetes, and multiple sclerosis. Biologics include vaccines, antitoxins, blood products, proteins, and monoclonal antibodies. Biologic medicines consist of molecules that are typically larger and more complex than traditional drugs (also known as “small molecule” drugs). As such, they are substantially more expensive to develop, manufacture, and monitor than small molecule drugs. One year of treatment can range from $50,000 to $250,000, and access to biologics is often restricted due to cost.
There are two types of follow-on biologics: biosimilars and interchangeable biological products. A biosimilar product is highly similar to the FDA licensed reference product and there are no clinically meaningful differences in terms of safety, purity, and potency of the product. An interchangeable product is required to produce the same clinical result as the reference product in any given patient. Although the FDA has not approved any follow-on biologic drug that might compete with a “reference” biologic, some state legislatures have recently considered and passed legislation that could affect the substitution of follow-on biologics for reference biologics. Commenters have raised concerns that state-level regulatory barriers may increase costs and lessen incentives to develop lower cost follow-on biologics, thus deterring the development of competition between reference and follow-on biologics.
The FTC’s workshop will examine how biologic competition could be affected by state regulation, and also by the naming conventions for follow-on biologics. Ways to structure the regulations and naming conventions to facilitate innovation and competition, while protecting patient health and safety, will be investigated. The workshop also will explore if and when potential entrants would be willing to invest in developing follow-on biologics using the abbreviated regulatory pathway created by BCPIA, as well as the experience of other countries with regulatory systems that enable follow-on biologic competition.
The FTC has invited the public to submit comments through March 1, 2014. Topics the workshop will address include:
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 biosimilar to, or interchangeable with, reference biologics? Would such a publication facilitate substitution?
The workshop, free and open to the public, will be held at the FTC Conference Center, located at 601 New Jersey Avenue, N.W., Washington, D.C., and will be webcast on the FTC’s site. The Commission will publish an agenda and list of speakers on the event’s webpage.
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