More Biosimilar Approvals Are Not Equal to Increased Competition, Stakeholders Say

While the “FDA deservers tremendous credit to enhance and expedite [biosimilars]… there is also a reluctance or hesitation to provide a full account that while the rate of approvals has picked up, the amount of biosimilars on the market [remains low]. Approval is not a synonym for competition," said Chester Davis of the Association for Accessible Medicines.
Samantha DiGrande
September 05, 2018
CMS Administrator Seema Verma opened the first day of the GRx+Biosims 2018 Conference in Baltimore, Maryland ,by delivering her keynote address about the actions taken and progress made by CMS to deliver on the drug pricing blueprint announced by President Trump and HHS Secretary Alex Azar in May. The meeting is hosted by the Association for Accessible Medicines (AAM) and takes place from September 5-7, 2018.

Verma began her address by reiterating the importance of controlling the ever-increasing drug prices in the United States, stating that, “by 2026, 1 in every $5 spent in our economy will be spent on healthcare.” The rate in which our healthcare costs are growing is unsustainable and addressing drug pricing in America has shifted from something “we would like to do, to something we must do,” said Verma.

She went on to vow support for the biosimilar marketplace, relaying that, at CMS, empowering patients and increasing choices are driving factors behind policy changes, because when patients have choices, cost and quality improve. In efforts to promote biosimilars, Verma noted a recently changed policy decision in which CMS now treats biosimilars as generics when determining co-pays for beneficiaries.

Further, she reinforced another recent policy change wherein Medicare Advantage plans will be able to employ step therapy as an additional negotiation tool. Verma explained that as the marketplace has seen more innovations and advancements in therapies being offered to patients, the payment side needs to see innovation as well. Though she and her colleagues have taken steps to address drug pricing and foster more competition, “There is still more to be done…[so] all Americans can benefit from 21 Century advancements in medicine.”

Verma was followed by Anna Abram, the deputy commissioner for policy planning, legislation and analysis at the FDA, who spoke largely of the actions the FDA has recently taken to further biosimilar competition in the marketplace—the most recent of which was a public hearing held yesterday at FDA’s White Oak campus in Maryland to yield industry feedback on the proposals outlined in the Biosimilar Action Plan (BAP).

Additionally, Abram spoke of certain inefficiencies found in the current processes that need to be addressed to bring drug products to market more quickly. Specifically, she noted that “On average, it takes 4 cycles for an [abbreviated New Drug Application, aNDA] to reach approval.” This wastes the time and money of both the drug developer and the FDA, as well as of patients who could be benefitting from a drug being available sooner.

Finally, meeting attendees heard from the president and CEO of AAM, Chester “Chip” Davis, offering AAM’s take on the current state of the market and the important role that biosimilars can play in ensuring greater patient access to lower cost drugs. Davis repeatedly commended the work of the FDA for improving the biosimilar approval process and subsequently approving 12 biosimilars in the United States. However, he noted that approvals only tell half the story.

While the “FDA deservers tremendous credit to enhance and expedite [biosimilars]… there is also a reluctance or hesitation to provide a full account that while the rate of approvals has picked up, the amount of biosimilars on the market [remains low]. Approval is not a synonym for competition.”

Though approving the products is critically important, he said, it is not a single solution. In closing, Davis stressed meeting participants to think of this as the starting point for a new conversation around drug pricing, because, as he sees it, “Generic and biosimilar industries are a huge component of the solution to solving the drug cost problem in this country.”
 

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