Some acts by companies in the biologics marketplace may go too far in preventing free market activity, according to Markus H. Meier, acting director for the Federal Trade Commission (FTC) Bureau of Competition.
The Federal Trade Commission (FTC) is a branch of law enforcement that draws its power from, by US terms, virtually ancient legislation such as the Sherman Antitrust Act of 1890, and lately Congress has nudged the agency to investigate anticompetitive practices in the pharmaceutical industry, including biosimilars, more closely, according to Markus H. Meier, acting director for the FTC’s Bureau of Competition.
“Some policy makers in Washington have asked ‘Why is this happening?’ ‘Why haven’t we achieved the goals and hopes and dreams?’ And sometimes this leads some of the politicians to ask the FTC, ‘Why aren’t you doing anything about this?’ And so, we are taking a close, hard look at this,” Meier said at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics.
Since 2018, the FDA has been examining patent settlement agreements between companies, as a result of amendments to the Medicare Modernization Act requiring that companies that settle, including originator biologics and biosimilars companies, submit copies of their settlement agreements to the FTC and Department of Justice, Meier said.
Pushing the Boundaries
“We do review those agreements, and I have a team of people who read every one of them and look for possible reverse payment [pay-for-delay] cases. The good news is that, for the most part, companies are doing it right, but there is always the possibility that companies don’t do that, and they push the boundaries off beyond where they’re allowed to go, and we may someday in the future bring a case involving a reverse payment. But we’ve got guidance on our website about the requirements under the Medicare Modernization Act amendments in 2018. There are penalties that Congress imposed for failing to file properly,” Meier told the conference audience, which included a large contingent of intellectual property attorneys from the biologics industry.
Pushing for greater competitiveness in the biologics marketplace is not a new emphasis at the FTC, but the interest in a free marketplace is as keen as ever and the biologics marketplace is under scrutiny, Meier said. That is illustrated in part by a joint FDA/FTC workshop earlier this year to collaborate on advancing biologics competition and overcome anticompetitive practices, he noted.
“We are working closely together to watch what’s happening in the space to try to understand if there are things, institutional things involving regulations, or potential law enforcement actions that we may need to bring, or things the FDA may need to do in terms of revising regulations, in such a way to make sure that we have robust competition in the biologic space,” he said.
The FTC has yet to bring a public enforcement action involving biologics in general or biosimilars in particular, he said. But he mentioned a few ongoing cases of interest to the FTC.
One of these is Pfizer v Johnson & Johnson (J&J), in which Pfizer has alleged anticompetitive practices in the use of rebates to prevent providers and pharmacy benefit managers (PBMs) from starting new patients on the company’s infliximab biosimilar (Inflectra). Inflectra has been on the US market since 2016 and has achieved a 10.5% market share. Meier said this is odd because the drug was introduced at a discount to J&J’s Remicade reference product at greater than 15% discount. The reason the biosimilar sales have not taken off, allegedly, is because J&J’s rebate deals specify that PBMs don’t get the rebates if they allow doctors to start new patients on the biosimilar. It’s assumed that patients already on the originator product are not going to want to switch to biosimilar if their conditions are stable, and PBMs would not want to lose the lucrative rebates they receive for patient maintenance on the originator biologic, Meier said.
“What’s interesting is that Pfizer is one of the largest drug companies in the world and yet it’s having problems, so maybe there’s really something going on here,” Meier said.
A second case Meier mentioned is Re: Humira (Adalimumab) Antitrust Litigation. This is a class action suit alleging that AbbVie entered into reverse payment agreements with numerous biosimilar companies to delay adalimumab biosimilar competition until 2023. “They did a series of settlements, one after another, with 5 different companies. The settlements are very complicated, involving not just settlement in the United States, but settlement of patent cases all across Europe and other parts of the world.”
The plaintiffs in that case alleged AbbVie illegally restrained trade by entering into settlements with competing biosimilar manufacturers to parcel out geographic markets. In June 2020, the United States District Court for the Northern District of Illinois (Eastern Division) dismissed the case against AbbVie because antitrust law did not cover the type of allegations made. Meier said the plaintiffs are likely to appeal and the FTC is watching closely.
Meier MH. The FTC, antitrust & biologics. Presented at: ACI 11th Summit on Biosimilars & Innovator Biologics; September 24, 2020.