On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
FTC Takes Aim at the Issue of Competition for Biologics and Follow-on Biologics
- The impact of state substitution laws and naming conventions on follow-on competition;
- How naming conventions may affect follow-on competition, including how state laws and regulations may be structured to facilitate competition while protecting patient health and safety; and
- Experiences of other countries in enabling follow-on biologic competition.
The FTC for a long time has focused on promoting competition between small-molecule brand and generic drugs, including challenging patent litigation settlements between brand and generic companies that allegedly delay generic entry. In 2009, the FTC held a workshop and solicited comments on competition involving follow-on biologics, which resulted in publication of the Follow-On Biologic Drug Competition report. Then, in 2010, Congress passed the Biologics Price Competition and Innovation Act to amend the Public Health Service Act, which outlines the FDA approval process for biologic drugs. The BPCIA creates a pathway for follow-on biologic competition that, although similar in intent to the Hatch-Waxman Act, is substantially different.
With the persistent growth of biologic medicines, the FTC is again giving attention to competition issues related to this important class of drugs. The workshop and comments will undoubtedly serve as an important venue for industry participants to be heard on the issues surrounding competition and an expedited pathway for follow-on biologics.
Authors: Leigh Oliver, Robert Leibenluft
Key words: biologics, follow-on biologics, competition, FTC
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017