US Supreme Court backs quicker approval of drug copies

Supreme Court

High court ruling speeds up generic biotech drug approval

The U.S. Supreme Court issued a mixed decision on the rules governing efforts to get low-priced alternatives to pricey biotechnology drugs on the market.

The Supreme Court dealt a blow to big pharma on Monday, ruling that companies making generic "biosimilars" to brand-name drugs don't have to wait an extra six months after gaining federal approval before selling their drugs.

The case, pitting biologics manufacturer Amgen against Novartis subsidiary and biosimilar manufacturer Sandoz, attempted to clarify what's known as the biosimilars "patent dance", which is the process by which companies must exchange and figure out the patent situation of a biologic and proposed biosimilar before the biosimilar comes to market. Since rising drug prices are a significant hindrance for patients and politicians, health experts believe bioimilars to succeed as a cheaper alternative to original medicinal brands. Even the six months at issue in the case can mean hundreds of millions of dollars in sales.

Novartis unit Sandoz in September 2015 began selling Zarxio, the first biosimilar drug to win USA regulatory approval.

Biosimilars are a bit more complicated than your average competing medicine: Unlike generics for chemical-based drugs like antibiotics that can be interchangeable with branded versions, the copycats of biologic medications, produced using living cells, have a few more caveats.

The Pharmaceutical Care Management Association, the national association for pharmacy benefit managers, said in a statement that the court's ruling "will help create more competition among costly biologic medications, which is the key to reducing overall prescription drug costs for consumers, employers, government programs, and others".

According to Courtenay Brinckerhoff, partner at Foley & Lardner, biosimilar applicants might be encouraged by the decision to participate in the "patent dance", to increase the chance that all disputes are resolved by the time a product is approved.

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The first issue in dispute was whether a 180-day notice of commercial marketing must be given to the reference product sponsor (RPS) after the biosimilar product is licensed by the Food and Drug Administration (FDA).

"The justices' unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments", said Carol Lynch, global head of biopharmaceuticals at Novartis' Sandoz unit.

Both drugs boost white blood cell counts in cancer patients to help fight infections.

California-based Amgen filed a patent infringement lawsuit claiming that Sandoz violated the 2010 Biologics Price Competition and Innovation Act.

In July 2015, the appeals court ruled that the 180-day notice must be given after FDA approval.

In his opinion (PDF) for the court, Justice Clarence Thomas said the plain language of the law allowed for the earlier notice.

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