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Supreme Court ruling on biosimilars ‘a win’ for patients
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A unanimous Supreme Court decision that accelerates the pace at which biosimilars can be marketed will greatly expand patients’ access to more affordable medications, according to one of the nation’s leading experts on biosimilars.
The court ruled biosimilar manufacturers do not need to wait an additional 6 months after FDA approval to market their agents, provided the standard exclusivity period for the biosimilar’s branded reference product has expired.
“The biggest issue in medicine is the high cost of prescription drugs, and the premise of biosimilars is to increase access and decrease costs,” Robert M. Rifkin, MD, FACP, medical director for biosimilars with McKesson Specialty Health and US Oncology Research, told HemOnc Today.
“The court’s decision — which eliminates an additional 6 months of exclusivity for the branded drug — is a win for biosimilars and a win for patients,” Rifkin added. “It allows for access to more affordable drugs quicker, so the cost savings will be realized earlier.”
Legal dispute
The Supreme Court’s ruling settled a dispute between Amgen and Sandoz — a division of Novartis that develops biosimilars — that arose from different interpretations of language in the Biologics Price Competition and Innovation Act.
The act established an abbreviated licensure pathway for biosimilars, which are copies of originator — or “reference” — biological medical products manufactured by different companies. Biosimilars and their reference products both are made from living cells.
The federal legislation allows manufacturers of biosimilars to market their products after a 12-year period of exclusivity for the biosimilar’s reference product.
The FDA in 2015 approved filgrastim-sndz (Zarxio, Sandoz), making it the first biosimilar product to receive regulatory approval in the United States.
Filgrastim-sndz is intended to decrease incidence of infection — manifested by febrile neutropenia — among patients with nonmyeloid malignancies who also receive myelosuppressive anticancer drugs. The FDA approved filgrastim-sndz for the same five indications as its reference product, filgrastim (Neupogen, Amgen).
When Sandoz began to market filgrastim-sndz soon after FDA approval, Amgen filed a patent-infringement lawsuit that claimed Sandoz violated a provision of the Biologics Price Competition and Innovation Act that required biosimilar manufacturers to provide a 6-month “notice of sales” to the reference product manufacturer.
Amgen contended the 6-month notice of sales could not begin until after a biosimilar manufacturer received regulatory approval for its product. A federal appeals court ruled in the company’s favor.
Sandoz — which contended that interpretation essentially provides an extra 6 months of exclusivity to the reference product manufacturer — appealed to the Supreme Court.
The high court issued an eagerly awaited unanimous decision June 12 in favor of Sandoz.
“It’s interesting that the court’s vote was not the usual 5-4 split, but rather 9-0,” Rifkin told HemOnc Today. “It’s very nice to see everybody — whether conservative or liberal — thinks that was reasonable.”
In the opinion, Justice Clarence Thomas wrote that Amgen’s “unpersuasive” arguments “cannot overcome the statute’s plain language.” Biosimilar applicants may provide the notice of sales before or after receipt of FDA approval, provided that the biosimilar is licensed on the date that commercial marketing begins, Thomas wrote.
“The justices’ unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments,” Carol Lynch, global head of biopharmaceuticals for Sandoz, said in a company-issued statement.
“As the global leader in biosimilars, it is our responsibility to help eliminate barriers so patients can access more affordable medicine,” Lynch added. “The results of this Supreme Court case reinforce that the work we are doing every day has meaning to the patients and customers we are here to help.”
Many of Amgen’s biologics are facing competition from biosimilars, but the company also has biosimilars in its own pipeline and eventually could benefit from the Supreme Court’s ruling.
“[Although] we are disappointed in the court’s decision on the notice of commercial marketing, we will continue to seek to enforce our intellectual property against those parties that infringe upon our rights,” company spokeswoman Kelley Davenport said in a statement.
Implications
Five biosimilars are approved in the United States, and filgrastim-sndz — the only one approved for use in oncology — has a supportive care indication.
“We still have a big issue in terms of the number of biosimilars in the approval process at the FDA,” Rifkin said. “We need to get a lot more drugs out there.
“If a biosimilar is approved but it has to sit on the shelves for 6 months before launch, that is extraordinarily costly to the manufacturer, keeping in mind that they invested a minimum of $200 million — and potentially upward of $300 million to $400 million — to develop that product,” he added. “This ruling will help because manufacturers will know — once they get approval — they can go out there the next day and launch their biosimilar.”
However, pricing must be taken into account, Rifkin said.
Most biosimilars — including filgrastim-sndz — have come to market with a 15% discount.
“Surveys we and other groups have conducted and published show you need a 25% to 40% price drop to really move the market,” he said. “I’m excited manufacturers don’t have to wait an additional 6 months, but once they get their drug licensed, they will need to realize that, in order to be competitive, they will have to drop their price much more than the standard 15% at launch.” – by Mark Leiser and Kristie Kahl
For more information:
Robert M. Rifkin, MD, FACP, can be reached at McKesson Specialty Health/The US Oncology Network, 10101 Woodloch Forest Drive, The Woodlands, TX 77380; email: robert.rifkin@usoncology.com.
Disclosure: Rifkin reports no relevant financial disclosures.