It’s all about timing

Supreme Court rules that market announcements for biosimilars can come before approval in Sandoz v. Amgen

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WASHINGTON, D.C.—Pharmaceutical companies are hardly strangers to the courts as firms do battle over patent claims, but the effects of such cases don't always spread beyond the companies involved. In Sandoz v. Amgen, however, the latest ruling in the three-year-long case stands to have a significant—and beneficial—impact on the industry, as it could allow biosimilar products to come to market sooner.
The case centers around the interpretation of certain facets of the Biologics Price Competition and Innovation Act (BPCIA) of 2009, in which the U.S. Food and Drug Administration (FDA) first created a pathway for the licensing and approval of biosimilars. Under the BPCIA, a company putting forth a biosimilar must provide the seller of the brand-name product with its application and provide notice a minimum of 180 days prior to commencing commercial marketing.
Sandoz Inc. submitted an application in May 2014 for approval for Zarxio, which is very similar to Neupogen from Amgen Inc. The FDA responded on July 7 to let Sandoz know its application was being reviewed; Sandoz alerted Amgen on July 8, and later in July told Amgen it would not disclose details of its application. The application received FDA approval March 6, 2015, of which Amgen was promptly informed by Sandoz.
As reported on the Oyez website, which is “a free law project from Cornell’s Legal Information Institute (LII), Chicago-Kent College of Law and” that follows Supreme Court cases, “In October 2014, Amgen sued Sandoz and claimed that Sandoz violated the Act because it failed to disclose the details of its application and did not give proper notice of commercial marketing before the FDA’s approval of its biosimilar product. The district court held that failure to disclose application details under the Act does not authorize the original seller to receive damages from the biosimilar product seller or prevent the sale of the biosimilar product. The court also held that an applicant may give notice of commercial marketing before FDA approval. The U.S. Court of Appeals for the Federal Circuit vacated the district court’s ruling and held that effective notice may only be given after the FDA has approved the application. Therefore, Sandoz’s notice was effective in March 2015 rather than July 2014, and Sandoz could not sell its biosimilar product until 180 days after the March 2015 notice. The court also held that, because the Act only permits remedies based on patent infringement claims, Sandoz’s failure to disclose the details of its application did not violate the Act.”
The June 12 ruling overturned that pronouncement. It was a unanimous decision, delivered by Justice Clarence Thomas, that companies filing for approval of biosimilars can give commercial notice prior to FDA approval, though the notice requirement cannot be enforced with an injunction, and companies are not required to take part in the “patent dance,” the extensive process that includes, in part, turning over the biosimilar application to the manufacturer of the brand-name product and exchanging product patents.
The Association for Accessible Medicines (AAM) and the Biosimilars Council, a division of AAM, supported the decision, noting in a statement that “The Association for Accessible Medicines (AAM) applauds the U.S. Supreme Court’s decision in Sandoz v. Amgen that will help speed patient access to biosimilar versions of expensive brand-name biologic medicines. In a unanimous ruling, the Court overturned a lower court decision that had effectively extended the brand manufacturer’s opportunity for monopoly protection from 12 years to 12 and a half years.”
“The Court’s decision in Sandoz v. Amgen is an important step in ensuring that patients will have early access to biosimilars,” the organizations added. “It precludes brand manufacturers from engaging in certain types of litigation gamesmanship that would delay biosimilar competition. The Court has also provided biosimilar developers with clarity around aspects of the statutory requirements of the BPCIA, which will allow biosimilars to enter the market without requiring an additional six-month wait which was not intended by Congress.”
Carlos Angulo, a member of the Food and Drug practice at Zuckerman Spaeder LLP, remarks that “It's since 2010 that we've had a pathway for biosimilars. That pathway has been somewhat slow in evolving, in part because FDA has been busy trying to implement the law and establish the guidelines and the processes by which biosimilars applicants can go and get approval from the agency, and this has taken some time.
“Now we've begun to see sort of a stream of approvals—there are five approvals so far, and there are many more products that are either in front of FDA now or in development—so I think that as FDA begins to finalize its guidances and its means of how it's going to regulate the process, you're going to see more applications and more approvals.”
Angulo filed amicus briefs for Sandoz v. Amgen at the Federal Circuit and Supreme Court levels as part of his work for the Biosimilars Council.
“I think the biggest impact [of this ruling] is that biosimilars applicants can go to market as soon as FDA approves them, assuming that they give notice 180 days before approval and assuming that the FDA review process takes that long,” Angulo tells DDNews. “What the Federal Circuit had said was that notice could only be given at the time of FDA approval, which would mean an additional 180 days of delay after approval.”
“Getting the product out on the market as soon as FDA approves it means that patients will have access to affordable versions of biologics that are currently on the market only in very expensive forms, the branded forms,” he adds. “This will obviously benefit biosimilars applicants, but it will also benefit patients as well as health insurance providers and many other stakeholders.”

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