New Legislation and BPCIA Uncertainties Dominate the Biosimilars Council Policy Update

On June 7, The Atlantic hosted a Policy Update on Biosimilars sponsored by The Biosimilars Council (Association for Accessible Medicines) as part of the publication’s “The Next Drug” series.

The discussion began with Steve Clemens, Editor-at-large of The Atlantic, interviewing Peter Welch, (D-Vermont). Clemens called Congressman Welch “one of the great gladiators in the drug industry” for his co-sponsorship of the Fair Access for Safe and Timely Generics Act of 2017 (or the FAST Generics Act). The proposed legislation would amend the Federal Food, Drug, and Cosmetics Act to prohibit license holders of FDA-approved drugs or biologics from restricting availability of their products for testing by competitors who seek to develop generics or biosimilars of their own.

Congressman Welch said that his legislation is “about affordability” of biologics. Calling the high prices of drugs “punitive” to taxpayers, employers, and individuals, Welch explained that his legislation seeks to balance the need to foster innovation in pharmaceuticals with the need to keep biologics affordable for patients. Welch, who also favors such cost-saving moves as importing cheaper drugs from Canada, says that biosimilars should be “ready to go on the market the moment that exclusivity ends,” calling efforts to extend patent protection through litigation “sketchy.” Welch also indicated a desire to see a 7-year rather than the current 12-year exclusivity period for drug patents.

Congressman Welch seemed to tap into patient frustration with what many view as unaffordable drug prices, and made reference to “the Martin Shkreli thing” (or Turing Pharmaceuticals’ choice, under then-chief Shkreli, to increase the price of a decades-old drug to $750 per pill, earning the outrage of patients and the media alike) in making his case for lower pricing for taxpayers and patients.

“There’s this pricing system that’s totally opaque,” Congressman Welch went on, saying that government will have to play a role in fostering market competition and bringing down prices, referencing the success of governmental price negotiation in European markets.

When Clemens asked whether President Trump’s administration is friendly to the legislation’s objectives, Congressman Welch responded, “is it friendly to any objectives?”

Following Congressman Welch’s interview, the session continued with a panel discussion among Bruce Artim, senior director, Federal Government Affairs at Eli Lilly and Company; Courtenay Brinckerhoff, partner, Foley & Lardner LLP; and Phil Nickson, associate general counsel for Intellectual Property at Momenta Pharmaceuticals.

Brinckerhoff gave a brief overview of Amgen v Sandoz, a case currently before The Supreme Court of the United States. The case, in which a decision is expected at any time, hinges upon whether a biosimilar applicant is required by The Biologics Price Competition and Innovation Act (BPCIA) to provide the reference product’s sponsor with a copy of its biologics license application and manufacturing. Also at issue is whether the 180-day pre-marketing notice requirement for biosimilar manufacturers may begin before or after a drug’s approval.

Brinckerhoff explained that the 180-day waiting period essentially delays patient access to drugs. Nickson responded that “we need to separate patents that protect new cures from those that were designed to…delay patient access to biosimilars,” calling unnecessary delays an “abuse of litigation.”

Atrim called Amgen v Sandoz “surprising,” and said that, in his view, the United States Congress had designed the BPCIA “to be an orderly system (in which) there’ll be notice, we could discuss these issues way before the patents expire. That seemed to be part and parcel of the system.” Atrim went on to stress that the courts will continue to struggle with legislative language that could have been better refined before being codified in law.

As for the future of the BPCIA, all of the panelists agreed that greater clarity of the law will benefit stakeholders. As Nixon put it, “we’re witnessing the birth of a new business era. What would be good for everybody is increased certainty in the courts.”

As the industry continues to await the court’s ruling in Amgen v Sandoz, legislators like Congressman Welch and his colleagues may do well to consider the lessons of “patent dance” litigation; clarity of language in the FAST Generics Act has the potential to prevent some future legal standstills in the ongoing push to improve patient access to biologics.