Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses the role that the Federal Trade Commission (FTC) may play in encouraging biosimilar competition.
Do you see any potential for regulatory agencies, such as the FTC, to weigh in on anti-competitive practices in the biologics and biosimilars world?
Absolutely. I can’t comment on whether they’re going to come in on a particular issue, but they’ve been very active in this area already. Years ago, when there were questions about the Hatch-Waxman Act and whether companies were abusing the patent listing process, they did a big study and actually commented to the FDA and spurred the FDA to change their regulations.
Most recently, they’ve been very active in the biosimilar and REMS area. There have been lawsuits by generic companies who could not get samples from the brand purportedly because the REMS prevented it. The FTC has come in with amicus briefs, they’ve come in with amicus briefs on some of the biosimilar issues, so they’ve actually been very, very active on this and I would expect that to continue in the future.