According to Azar, "Those Against Biosimilars Are Simply on the Wrong Side of History"

HHS Secretary Alex Azar offered a view of hope and optimism for the future of the American healthcare market in his remarks delivered as the closing keynote address at the Association for Accessible Medicine’s Access! 2019 meeting.
Samantha DiGrande
February 06, 2019
HHS Secretary Alex Azar offered a view of hope and optimism for the future of the American healthcare market in his remarks delivered as the closing keynote address at the Association for Accessible Medicine’s Access! 2019 meeting.

Azar’s remarks, delivered after President Trump gave his second State of the Union address, outlined a vision for a more competitive and transparent healthcare market. Greater transparency in regard to drug pricing has become a calling card not only for the Trump administration, but for patients and biosimilar developers alike.

In addition to greater transparency, Azar is also looking to increase competition in both the generic and biosimilar space. “We’re working to ensure that we have a market that rewards competition; where negotiators are incentivized to choose the lowest-cost options—often generics—and where low-cost generic options can translate into low out-of-pocket costs for patients.”

However, in order to build on the success of the generic market, and create the same kind of success with biosimilars, the US healthcare system must also adapt its payment systems to allow for new competition.

Azar acknowledged the challenges that have been set forth in front of the biosimilars market, but he also recognizes the tremendous promise that it holds. “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 was clear about how he intends to achieve these savings and uptake goals in biosimilars: pharmacy-level interchangeability. “Interchangeability is the ultimate goal of the Biosimilars Action Plan that [FDA] Commissioner [Scott] Gottlieb launched last summer,” he said.

Though this may be the ultimate goal, Azar acknowledged that this is no small feat, and before it can be accomplished, a lot of education needs to be done to clear up confusion in the space caused in part by the dissemination of misinformation about biosimilars. "Those trying to hold back biosimilars are simply on the wrong side of history,” he said.

Azar went on to discuss some other initiatives the FDA and HHS are evaluating as a means to address situations where generic and biosimilar competition has been “anemic,” such as the potential importation of drugs without patents or exclusivities or instituting the International Pricing Index. These remedies, he said, would help to “inject new competition in the event of price spikes that restrict access to medicines.”

He even took a stab at the drug market, saying that it really isn’t a market at all because there’s no other way to describe a system where higher priced products regularly beat out lower-priced products.

Overall, while Azar touted the successes of the administration in taking steps towards increasing competition and lowering the cost of drugs in the country, he agreed that there was more to be done.

"Of course, we know that a truly transparent drug market, just like a successful market for biosimilars or a competitive market for healthcare services generally, isn't right around the corner," he said. "But I think the experience and achievements of many of you in this room should give us plenty of reason for optimism... Join with us as we move forward to bring your experiences and your successes to the rest of American healthcare.”

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