If you have an ACS member number, please enter it here so we can link this account to your membership. (optional)

ACS values your privacy. By submitting your information, you are gaining access to C&EN and subscribing to our weekly newsletter. We use the information you provide to make your reading experience better, and we will never sell your data to third party members.



U.S. Supreme Court ruling gives biosimilar drugs a boost

Companies can market generic biological medicines sooner

by Glenn Hess, special to C&EN
June 14, 2017 | A version of this story appeared in Volume 95, Issue 25

Photo shows a small box labed Zarxio and an insert for the box containing five filled syringes.
Credit: Sandoz
The legal dispute started with the Sandoz product Zarxio, a generic competitor to Amgen’s Neupogen.

Makers of generic versions of biological drugs will be able to get their products on the market sooner because of a U.S. Supreme Court ruling on June 12.

The high court ruled that generic makers do not need to wait for U.S. Food & Drug Administration (FDA) approval before providing six months’ notice to brand-name rivals of their intention to launch a competing product.

The 9-0 decision in favor of generic drugmaker Sandoz in a dispute with biotech giant Amgen means that biosimilars, lower-cost, near-copies of pricy biologic medicines, will be able to reach the market sooner. This could potentially save consumers billions of dollars.

“The Supreme Court’s unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments,” says Carol Lynch, global head of biopharmaceuticals at Sandoz.

The dispute involves Zarxio, an drug that Novartis’s Sandoz developed that competes with and sells for about 15% less than Amgen’s Neupogen, which has sales of about $1 billion per year. The drug helps boost white blood cells in cancer patients.

The case arose after the two companies disagreed over how to interpret language in the Biologics Price Competition & Innovation Act. Congress passed that law in 2010 to create a regulatory pathway for FDA approval of biosimilars.

A key issue in the dispute was whether a requirement for a 180-day notice of intent to launch must be given to the developer of the original product before or after the biosimilar is licensed by FDA.

Amgen asserted that a biosimilar applicant must wait until its product is approved by FDA before providing notice. Sandoz argued that notice may be given before approval.

In 2015, a federal appeals court ruled that biosimilar developers must give the 180-day notice after FDA approval. But the Supreme Court disagreed, saying that an applicant may provide notice before obtaining a license.

“The statute’s use of the word ‘licensed’ merely reflects the fact that, on the date of the first commercial marketing, the product must be licensed,” Justice Clarence Thomas wrote in the Court’s opinion. “Accordingly, the applicant may provide notice either before or after receiving FDA approval.”

CORRECTION: This story was updated on June 28, 2017, to reflect that Zarxio helps boost white blood cells in patients with cancer.



This article has been sent to the following recipient:

Chemistry matters. Join us to get the news you need.