FDA refreshes biosimilar action plan, but uptake may be in hands of payers like Cigna
26 Apr 2024
Drug ApprovalBiosimilar
The FDA may have approved its fiftieth biosimilar this week and renewed its commitment to “innovation and competition” surrounding the therapeutic class, but whether patients are prescribed and receive biosimilars seems to be dependent on the decisions made by payers and pharmacy benefit managers (PBMs).
AbbVie, for example, has been more successful than expected at staving off competition for its blockbuster biologic Humira (adalimumab), as evidenced by its quarterly earnings report on Friday – although new policies announced by CVS and Cigna this year may finally make a dent in the drug’s sales.
Zero cost to patients
The new policy could remove one of the largest barriers to broad biosimilar adoption. In a FirstWord poll fielded to 126 US physicians in March, 43% cited payer coverage and cost as a reason why Humira biosimilars haven’t been used more widely. For more, see Physician Views Results: Lack of financial incentive and prescriber confidence stalling adoption of biosimilar Humira products.
According to Evernorth, the biosimilar will be produced for its affiliate private label pharmaceutical distributor, Quallent Pharmaceuticals, through agreements with multiple manufacturers. Evernorth did not specify which biosimilar, though it is most likely TevaTeva and Alvotech's Simlandi (adalimumab-ryvk), the first high-concentration product to be approved as interchangeable with Humira. The medication received FDA clearance in February.
The pharmacy, care, and benefits solutions provider is at least the second this year to announce a new policy that pushes patients towards a Humira biosimilar. In January, PBM CVS Caremark replaced the autoimmune therapy with biosimilar versions on the majority of its commercial prescription plans. In just weeks, the change led to an “explosion” in new prescriptions for Sandoz’s Hyrimoz (adalimumab-adaz).
Humira contracts ‘have teeth’
While AbbVie assured investors during a call Friday that Humira’s $2.3 billion in first-quarter revenues – down from $3.5 billion last year – are “right in line with our expectations,” participants still peppered the pharma’s C-suite with questions seeking to clarify just how much CVS’s policy may affect the biologic’s sales.
Chief commercial officer Jeffrey Stewart confirmed that AbbVie has “very solid contracts with our payers through 2024” for Humira, and shed a little light on how the pharma establishes for-parity contracts.
“We do put some controls in place in some cases, but not all. We seek multi-year contracts with our payers to try to establish the relationship, the pricing, et cetera, and we will think of ways to make sure that those contracts can hold. So they have some teeth in them. They can't just be willy-nilly discarded," he explained.
More broadly, Simon Baker, head of global biopharma research at Redburn Atlantic, pointed to “a degree of political noise around the role of PBMs in blocking rather than assisting biosimilar uptake” and asked AbbVie’s leadership whether they expect that attention “to come to anything in terms of structural changes within the market.”
Stewart responded that “there's a very reasonable chance of a sort of transparency reform,” but that the pharma doesn’t expect “a major wholesale change… happening in the near-term.”
FDA details action plan
While wholesale change may not be on the docket, the FDA listed “a robust and competitive biosimilars marketplace” as one of the four overarching goals of its updated Biosimilars Action Plan, released this week.
The plan details the FDA’s commitment to crack down on manufacturers who are “inappropriately delaying the approval of biosimilar or interchangeable competitors,” as well as an initiative to “identify and counteract misinformation about biosimilar and interchangeable biosimilar medications.”
But just how much the US regulator can boost competition and influence markets, however, remains to be seen.
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