AAM's Christine Simmon on Biosimilars Council Initiatives and Educating Around Interchangeability

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.