Supreme Court to review Amgen, Novartis case on biologics: 6 takeaways

The U.S. Supreme Court on Friday agreed to review a dispute between Basel, Switzerland-based Novartis and Thousand Oaks, Calif.-based Amgen on whether drug companies must wait six months after winning regulatory approval before selling "copycat" versions of biologic drugs, reports Reuters.

Here are six things to know about the dispute.

1. Amgen first sued Sandoz — a unit of Novartis — in 2014, claiming Sandoz's cancer drug Zarxio infringed on patents for its own drug, Neupogen. Zarxio costs 15 percent less than Neupogen's list price.

2. The two companies also disagreed on the interpretation of a 2010 federal law requiring a biosimilar drugmaker to give the brand-name manufacturer 180 days notice before launching the new version.

3. The U.S. Court of Appeals for the Federal Circuit in Washington ruled in favor of Amgen in July 2015, saying the 180-day notice must be given after approval from the Food and Drug Administration.

4. Novartis appealed the decision to the U.S. Supreme Court last February, arguing the Federal Circuit's decision gave Amgen an extra six months of exclusivity — on top of the 12 years already provided for under the law — which drives up healthcare costs, according to Reuters.

5. Amgen opposes Novartis' appeal, arguing the statute is meant to foster innovation and clearly states the 180-day period cannot begin until a biosimilar is approved by the FDA, according to the report.

6. The Supreme Court justices also agreed to resolve Amgen's appeal in the same case regarding whether biosimilar drugmakers must give brand-name manufacturers a copy of their drug application after it is submitted to the FDA, according to the report.

More articles on supply chain:

Fujifilm to pull 4 older duodenoscope models from use
Target invests in supply chain tech startup
4 ways the FDA is working to boost diversity in clinical trials

 

 

Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars