Supreme Court's Sandoz-Amgen Decision Boosts Biosimilars

High court ruling speeds up generic biotech drug approval

The U.S. Supreme Court delivered a smashing win for the youthful biosimilars industry by swatting away efforts to delay the lower-cost medicines, and its ruling teed up new battles for lower courts and maybe even Congress, attorneys say. Zarxio was approved for use in Europe in 2009.

In addition, in a footnote, the Court clarified that it expressed no view on whether a district court could take into account an applicant's violation of §262 (l)(2)(A) (or any other BPCIA procedural requirement) in deciding whether to grant a preliminary injunction under 35 U.S.C. § 271 (e)(4)(B) or §283 against marketing the biosimilar. The FDA has approved five biosimilars to date, but only two - Sandoz' Zarxio and Pfizer's Inflectra (infliximab-dyyb) - have actually been launched for commercial sale.

The case is Sandoz v. Amgen.

For makers of branded biologic drugs, the decision will mean billions of dollars in lost sales and deprive them of invaluable time to prepare for cheaper generic competition. Sandoz, in defending the suit from Amgen and later appealing the federal appeals court's decision, argued Amgen's interpretation of the BPCIA would effectively extend its 12-year regulatory exclusivity.

At issue in the case was whether makers of biosimilar drugs could give a required 180-day marketing notice before FDA approval, which would allow the drug maker to bring the copycat drug to market more quickly. The high court concluded that the language of the Biologics Price Competition and Innovation Act (BPCIA) makes it clear that "the applicant may provide notice either before or after receiving FDA approval".

The dispute centered on a section of the 2010 Affordable Care Act that created an expedited path for regulatory approval of biosimilars while trying to respect the patent rights of brand-name manufacturers.

"I think one of the functions of the patent dance was to get the parties talking about patents early and potentially settling certain patent issues, before the start of any litigation".

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As part of Monday's decision, the Supreme Court held that an injunction mandating biosimilar developers exchange information with branded drugmakers would not be available under federal law.

In July 2015, the Federal Circuit ruled that the 180-day notice must be given after Food and Drug Administration approval.

The decision, unsurprisingly, pleased Sandoz.

Novartis said in a statement that the ruling "will help expedite patient access to life-enhancing treatments".

But in their opinion Monday, the justices said Amgen's "arguments are unpersuasive, and its various policy arguments can not overcome the statute's plain language".

Amgen fought Sandoz in court to defend its drug Neupogen (filgrastim) from biosimilar competition.

Christopher Loh, partner at Fitzpatrick, Cella, Harper & Scinto, disagreed with Brinckerhoff, explaining that the practical effect of the ruling will be to permit biosimilar applicants to bypass the requirements of the dance.

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