After the Association for Accessible Medicines’ (AAM’s) Access! 2019 annual meeting came to a close last week, The Center for Biosimilars® spoke with Christine Simmon, senior vice president of policy and strategic alliances, AAM, and executive director, AAM’s Biosimilars Council, to get her take on some of the outcomes of the meeting.
After the Association for Accessible Medicines’ (AAM’s) Access! 2019 annual meeting came to a close last week, The Center for Biosimilars® spoke with Christine Simmon, senior vice president of policy and strategic alliances, AAM, and executive director, AAM’s Biosimilars Council, to get her take on some of the outcomes of the meeting.
“I think one of the biggest takeaways from the meeting was the continuing importance of biosimilars. Of course, we had a dedicated biosimilars session, but biosimilars really came up in every session, and I thought that was very telling,” said Simmon.
The biosimilars session she referenced included a panel during which various biosimilar stakeholders and industry experts discussed how to identify and address “biosimilar shenanigans.” The opening presenter of the session, Carol Lynch, president of Sandoz US and head of North America, explained that data show that if all FDA-approved biosimilars had been marketed in a timely manner, Americans could have saved $4.5 billion.
Simmon touched upon this issue as well, stating that “There are significant concerns about the viability and ultimately the sustainability in the [United States].” Interestingly, Simmon noted that in her own discussions with meeting attendees, she “heard recognition from more people that the European successes around biosimilars—which are still very praise worthy—is evolving there to a sustainability issue as well.” She stressed that while the US biosimilar market has not nearly reached its peak, stakeholders need to start planning ahead for the sustainability of the market.
The importance of the biosimilars market, as well as the savings it could achieve for patients, was referenced also in the closing keynote address delivered by HHS Secretary Alex Azar. “Biologic drugs, today, represent almost 40% of prescription drug spending. The challenges are real, but so is the potential for competition and savings. Imagine doing to 40% of the pharmaceutical market just some fraction of what generics have already done to the other 60%,” said Azar. He went on to discuss how he intends to achieve these savings and increased uptake in biosimilars: pharmacy-level interchangeability.
Simmon explained that interchangeability has been a hot topic for AAM’s Biosimilars Council, too. “A major focus area for the council is educating around interchangeability and misinformation. Not even so much how to do interchangeability, but to some degree, I guess you could say the interplay between interchangeability designations and market uptake,” she said. “It’s another misconception—and we’ve heard this misconception among payers and physicians as well—that they’re waiting for interchangeability to really get on board with biosimilars.”
FDA has been working on finalizing a guidance around interchangeability and how biosimilar developers can achieve the designation. The guidance is expected to be released in the upcoming months.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Dr Sophia Humphreys Provides Calls to Action to Ensure Biosimilar Market Sustainability
April 30th 2024During her presentation during Festival of Biologics USA, Sophia Humphreys, PharmD, director of formulary management at Sutter Health, gave an overview of current challenges and opportunities for the biosimilar market and offered calls to action for multiple stakeholders.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.