On February 4, 2014, the Federal Trade Commission (“FTC”) hosted a day-long public workshop on “Follow-on Biologics: Impact of Recent Legislative and Regulatory Naming Proposals on Competition” to discuss the potential impact of state regulations and naming conventions on competition involving biologic medicines and follow-on biosimilar drugs. The workshop reflects the FTC’s renewed interest in a topic on which it has largely been silent since the June 2009 release of its report on follow-on biologic drug competition. Biologics comprise some of the best-selling and fastest-growing pharmaceutical brands on the planet, and include all three of the world’s top-selling drugs — AbbVie’s Humira®, Johnson & Johnson and Merck & Co.’s Remicade®, and Amgen and Pfizer’s Enbrel®. Biologics are derived from living organisms or manufactured in living cells using recombinant DNA biotechnologies. Unlike more common chemically synthesized small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Moreover, because no two cell lines, developed independently, can be considered identical, biologic products cannot be fully copied. Biologics are often expensive compared to conventional treatments, and patient access to biologics is often restricted because of cost. These cost issues led Congress to enact the Biologics Price Competition and Innovation Act of 2009, requiring the FDA to develop an abbreviated pathway for approval follow-on biologics, similar to the pathway for approval of “generic” drugs. Follow-on biologics include “biosimilars” that are expected to produce the same clinical results as previously approved biologic products, and “interchangeable” biologics, that may be substituted for brand biologics without the intervention of a health care provider. Notwithstanding its authority, and the availability of some biosimilar products in Europe, the FDA has not yet approved any follow-on biologic for sale in the U.S. However, biosimilars are drawing increased attention since twelve biologics with combined global sales of more than US $67 billion (including Humira, Remicade and Enbrel) will lose patent protection by 2019. In opening remarks, the FTC reiterated its desire that competition in the biosimilar industry be as vigorous as possible, consistent with patient safety. It further noted that to the extent regulations or restrictions are necessary, they should be no broader than necessary to protect consumers from significant harm. Subsequent discussion focused on two main topics: the anticipated competitive impacts of enacted and proposed state laws that impose certain requirements (e.g., physician notification) when biosimilars are dispensed to patients at the pharmacy; and whether the existing paradigm for naming medicines that employs a proprietary trade name and a nonproprietary name reflecting certain scientific characteristics of the product, should be used for biologics and follow-on biologics. In both discussions, debate focused on whether notification and naming measures that tend to emphasize differences between biologics would needlessly inhibit the development and use of biosimilars, or whether such measures were justified by pharmacovigilance concerns, including the desire to be able to track problems to specific biosimilar products.Slides and a video transcript of the workshop are available on the FTC website. The FTC will continue to accept public comments regarding topics discussed at the workshop until March 1, 2014.
This article was prepared by Norton Rose Fulbright lawyer Kathy Grant (firstname.lastname@example.org / +1 210 270 7182) of the US Intellectual property group in San Antonio.