Policy Concentrates RESEARCH FUNDING
PHARMACEUTICALS
A boost for biosimilar drugs NIH backs 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 last week. The high court ruled that generic makers do not need to wait for U.S. Food & Drug Administration 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 drug maker Sandoz in a dispute with biotech giant Amgen means that biosimilars— lower-cost, near-copies of pricey 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, a 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 red blood cells in people with cancer. 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
The legal dispute started with the Sandoz product Zarxio, a generic competitor to Amgen’s Neupogen. 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.”—GLENN HESS, special to C&EN
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C&EN | CEN.ACS.ORG | JUNE 19, 2017
Amount of today’s global electricity demand that could be offset between now and 2030 by quick deployment of high-efficiency lighting, cooling, and appliances. Source: The International Energy Agency’s “Energy Technology Perspectives 2017” report
off funding limits for researchers Facing a storm of criticism, the National Institutes of Health has abandoned a plan that would have limited the number of grants any one scientist could get. The Grant Support Index, which NIH rolled out last month, used a formula to determine whether an individual investigator could receive additional NIH funding. NIH leaders said it would effectively limit the number of grants any one scientist could get to three at one time. Complaints quickly came rolling in that the plan would hinder collaboration, work against those running complex trials or research networks, and discourage scientists from overseeing training or infrastructure grants. Another concern was that the methodology was not ready for prime time. “We have heard you,” NIH Director Francis Collins said last week. “We are shifting the approach quite substantially.” NIH had originally acted out of concern that early- and midcareer scientists were being hurt by the hypercompetitive grant funding environment. So rather than limit funding overall, the agency has instead said it will specifically drive more funding into support for early- and midcareer scientists, who have found it increasingly difficult to get grants renewed. The Next Generation Researchers Initiative will start with $210 million this year and eventually ramp up to $1.1 billion in dedicated funds. It will steer support specifically toward early- and midcareer scientists, including through existing funding mechanisms, such as the National Institute of General Medical Science’s Maximizing Investigators’ Research Award. (NIGMS funds more chemistry than any other institute.) And the agency will continue to track funding data to make sure the new approach is working.—ANDREA WIDENER
CREDIT: SANDOZ
U.S. Supreme Court says companies can market generic biologics sooner
