The US Supreme Court on Tuesday ruled that biosimilar developers do not have to wait six months after regulatory approval to bring their products to market, marking a boon for companies developing the new class of cheaper, near-replicas of expensive biologic drugs for the US.
The landmark decision is expected to benefit biosimilar developers around the world, including South Korea’s Celltrion as well as Samsung Bioepis, which are planning to commercialize their products in the US in the future.
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The high court’s nine justices unanimously overturned a lower court’s decision that had mandated Swiss pharmaceutical giant Novartis withhold its biosimilar referencing Amgen’s blockbuster cancer drug Neupogen for six months after receiving the US Food and Drug Administration’s approval.
The new ruling sets a new guideline for how long big-brand pharmaceutical companies can shield their blockbuster biologic drugs from competing biosimilars sold at cheaper prices.
Under the country’s 2010 Affordable Care Act, biosimilar developers are required to give 180 days of notice to the maker of the original biologic drug before marketing and selling a new biosimilar.
In the case of Novartis-owned Sandoz, it began marketing its biosimilar drug Zarxio in the US six months before the FDA’s approval, issued in March 2015. Amgen had rejected this interpretation, saying this 180-day notice should come after the biosimilar is approved.
The court sided with Sandoz, saying that a biosimilar developer can give its 180-day notice prior to obtaining the FDA’s approval, meaning it can immediately begin selling the drug after clearing regulatory approval.
This interpretation of the six-month period has major implications for the pharma industry as it could translate into hundreds of billions of dollars of sales at stake for the defending firm as well as faster patient access to cheaper drugs.
Biosimilar companies that had cleared regulatory approval to sell their cheaper products in the US had to wait 180 days before selling them, considering the lower court’s initial decision on Sandoz’s case.
While continuing to appeal the initial ruling, Sandoz had delayed the US launch of Zarxio by six months. Celltrion’s Remicade biosimilar Inflectra also waited six months after approval before starting to sell the drug in the US via its marketing and sales partner Pfizer.
Under the Supreme Court’s new interpretation, Samsung Bioepis, whose Remicade biosimilar named Renflexis obtained the FDA’s approval in April, can technically begin selling the drug immediately. It does not have to wait until October, as would have been mandated by the previous interpretation of the 180-day rule.
Samsung Bioepis’ US marketing and sales partner Merck & Co., known as MSD globally, is in charge of deciding the exact timing of Renflexis’ US market entry. It has yet to reveal a timetable for its launch plans.
By Sohn Ji-young (
jys@heraldcorp.com)
