On June 7th, The Atlantic presented “The Next Drugs: The Future for Biosimilars – An Atlantic Policy Update on Biosimilars” at the Newseum in Washington, D.C. The third in a series of Atlantic biosimilars briefings underwritten by The Biosimilars Council, the event gathered more than 100 influencers from a diverse group of stakeholders to discuss the future of biosimilars, including patient access, the patent landscape, and the role of Congress and legislation.
Drug prices remain top of mind for Americans and discussion at the event made it clear that policymakers are thinking about ways to address the issue.
U.S. Representative Peter Welch (D-VT) spoke with Steve Clemons, Washington Editor at Large, The Atlantic, about the role generics have played in the drug market. “Generic manufacturers do tremendous good in helping bring prices down,” said Rep.Welch. “The biosimilars industry has an opportunity to bring these new medications to people and provide competition.” Rep. Welch is currently sponsoring the FAST Generics Act (H.R. 2051), which would end REMS abuse and give biosimilars a clearer pathway for market entry.
The Biosimilars Council is committed to safeguarding patient safety. Our members strongly support current FDA-mandated REMS programs to ensure that the beneﬁts of a drug outweigh its safety risks. You can learn more at www.stopREMSabuse.com.
There was also robust conversation about the patent litigation landscape for biosimilars, specifically on the Sandoz Inc. v. Amgen Inc. case and the impact of the Supreme Court’s ruling on the biosimilar patent dance and market exclusivity. The discussion was timely – the Court issued its ruling the following week, unanimouslyoverturning a lower court decision that had effectively extended the brand manufacturer’s opportunity for monopoly protection for an additional six months. The ruling is a huge victory for patients and consumers and will support faster access to lower-cost biosimilar medicines for millions of patients facing life-threatening diseases, like cancer and multiple sclerosis.
“We need to separate both patents that protect new cures from those that are designed to delay patient access to biosimilars. There are certain patents out there for certain molecules that I think we would all agree don’t protect new cures but are rather designed to delay patient access through abuse of litigation and various other strategies.”
– Phil Nickson, Associate General Counsel, Intellectual Property, Momenta Pharmaceuticals
The Council was honored to champion this forum as part of our ongoing campaign to educate and engage patients, providers and policymakers about the opportunities and challenges facing the future of biosimilars and the healthcare industry. We look forward to continuing the dialogue on these issues in September at our annual conference, Leading on Biosimilars. Reserve your spot here: http://biosimilarscouncil.org/leading-on-biosimilars
Our special thanks to all who participated, especially:
- Representative Peter Welch (D-VT)
- Steve Clemons, Washington Editor at Large, The Atlantic
- Bruce Artim, Senior Director, Federal Government Affairs, Eli Lilly and Company
- Courtenay Brinckerhoff, Partner, Foley & Lardner LLP
- Phil Nickson, Associate General Counsel, Intellectual Property, Momenta Pharmaceuticals
- Olga Khazan, Staff Writer, The Atlantic
- Emily Akhtarzandi, Managing Director, AtlanticLIVE
If you were unable to join the live event, the full video is available here:
You can review Tweets from participants at http://bit.ly/2mTNWTH.