WASHINGTON, D.C.—During oral arguments at the U.S. Supreme Court on Wednesday, Amgen and Sandoz clashed over the intent of the Biologics Price Competition and Innovation Act in a case set to have a big impact on future biosimilar launches.
Lawyers for the two companies fielded a host of questions from the justices Wednesday morning, with attention centering on two key issues: One, whether biosimilar companies should be required to hand over their full FDA approval applications (aBLAs) to the makers of the original branded product, and two, when the biosim companies are able to provide “notice” of their intent to market a biosim, thus triggering a six-month waiting period.
Amgen, which markets the reference product Neupogen in this case, argued that the notice to market a biosim can’t start until FDA approval. Sandoz, plus other biosim developers and organizations through amicus briefs, argued that such an interpretation would mean an extra six-month “exclusivity windfall” that Congress didn’t intend to create with the BPCIA.
“Congress would not have extended the 12-year exclusivity period in such a bizarre way,” Deanne Maynard, the company’s representative, told the justices on Wednesday.
Pushing back, Amgen’s attorney Seth Waxman said “you can’t give notice of anything” until the FDA has specified with an approval about the biosimilar’s molecule, indication and manufacturing process.
During more than an hour of oral arguments, attorneys and justices parsed the intent of words in the law such as “shall” and “license.”
Questioning Sandoz’s attorney, Justice Stephen Breyer asked how a company could provide notice of an intent to market a biosim “if you don't know what the license is?”
Justice Breyer continued by pointing out that it’s a decision with “huge implications” in a very technical field. He argued that that because the FDA is involved “intimately,” it’d be “sensible” for that agency to assist with the dispute.
The Supreme Court took on the case after a Federal Circuit court ruled with Amgen on one issue and with Sandoz on another. In a 2015 decision, the appeals panel ruled that Sandoz was required to share its abbreviated biologics license application (aBLA), and provide marketing notice after its biosim won FDA approval. Still, the decision described the statute a “riddle wrapped in a mystery inside an enigma.”
Though a decision from the United States’ top court isn’t expected until June or July, drugmakers already know the eventual ruling will leave a big mark on the biosim field. It will determine whether developers have to share their application with branded biologics developers, and when they’ll be able to launch their copies.
According to Courtenay Brinckerhoff, intellectual-property partner in the biosimilars practice at Foley & Lardner LLP, the latter issue is likely to have a bigger effect on the industry.
“While companies developing biologics and biosimilars are interested in both issues, stakeholders on both sides are more interested in the ‘pre-marketing notice’ issue, since that issue directly impacts exclusivity periods, market entry dates, and competition in the marketplace,” she said in a statement.
Hoping to launch five biosimilars by 2020, Sandoz eventually waited out the six-month delay and launched its biosim of Amgen’s Neupogen back in 2015 after a legal war. The company asked the Supreme Court to weigh in on the issue last year in an effort to win reprieve for future biosim launches.