Supreme Court to Weigh How Soon Firms Can Sell Copycat Biotech Drugs

By Brent Kendall 

WASHINGTON -- The Supreme Court on Friday agreed to consider a dispute between Novartis AG and Amgen Inc. that could determine how soon cheaper, copycat versions of biotechnology drugs can be sold to consumers.

At issue is whether a lower court was correct when it made Novartis's Sandoz subsidiary wait an extra 180 days after U.S. Food and Drug Administration approval in 2015 before it began selling Zarxio, a biosimilar version of Amgen's Neupogen, a drug used to help cancer patients boost their white blood cell production during chemotherapy.

Congress, through a provision included in the 2010 Affordable Care Act, sought to spur potential price competition for expensive biologic drugs by creating an abbreviated approval pathway for so-called biosimilar medicines.

Zarxio was the first biosimilar approved by the FDA, in March 2015. After the market delay at issue in the Supreme Court case, Sandoz began selling the drug in September 2015 at a 15% discount to Neupogen.

Brand-name biotech drugs and biosimilars are manufactured with living, biological materials, and they generally are more complex than traditional chemically synthesized drugs and their generic-drug equivalents.

So far only a handful of biosimilars have received FDA approval. The go-to-market timing on future biosimilars could depend on the Supreme Court's ruling.

Sandoz argued it should have been allowed to sell Zarxio six months sooner. The firm said it gave Amgen 180 days notice before it marketed a biosimilar product, and that was all Congress required. Lawmakers didn't intend for biosimilar competitors to wait another 180 days after FDA approval, Sandoz said.

The Supreme Court previously invited the Obama administration to submit a brief on whether the court should hear the case. The administration said it should, and it sided with Sandoz in arguing that the lower court's interpretation for Amgen was incorrect.

Amgen argued that the required 180 days notice for a new biosimilar product must come after FDA approval. That approach gives the original biotech drug manufacturer time to consider whether to bring patent infringement claims to try to stop the new drug. If competitors are allowed to give notice before FDA approval, the incumbent drug company and the courts would waste time and resources considering whether to block a potential competing drug that may never be approved, Amgen said.

The high court is likely to hear oral arguments in April, with a decision expected before July.

Write to Brent Kendall at [e-mail]

(END) Dow Jones Newswires

January 13, 2017 16:06 ET (21:06 GMT)

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