Biosimilar Groups Offer Proposals to Help US Better Mirror EU Successes

Regulatory NewsRegulatory News | 19 March 2019 |  By 

With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups from the US and EU on Tuesday called for several structural changes so that the US can see the same competitive environment that Europe currently enjoys.

Specifically, the Biosimilars Forum and Medicines for Europe are calling for: “a fair market that allows those products that initiate lower prices to gain market share”; “a strong biosimilars pipeline with scientifically-sound and efficient, well-resourced, and timely review by FDA”; and a “framework that aligns incentives across all stakeholders to ensure appropriate uptake.”

The report uses the example of the UK, which created predictability for biosimilar sponsors ahead of product launches and allowed NHS England to benefit from multiple timely bids that optimized competition and access as soon as key patents expired.

“The clear communication of roles, processes, and goals helped prime the market for successful biosimilars uptake, reflecting the proven premise that sound public policy and proactive preparation helps commercial policies succeed,” the report says.

For US policymakers, the two groups also call for certain “biosimilar-forward” proposals to be implemented “immediately and concurrently” by the Centers for Medicare and Medicaid Services, payers and others to drive uptake.

Such proposals include giving biosimilars “automatic priority tiering in formularies and reduced or zero-dollar co-pays for patients,” banning “fail-first policies with the reference product before a biosimilar can be prescribed,” incentivizing switching to biosimilars by physicians and requiring commercial insurers “to provide access to biosimilars, with lower or zero co-pays, for all beneficiaries.”

They also call for FDA to help physicians understand that an interchangeability designation “is not relevant to them and does not indicate a ‘better biosimilar.’”

As far as what FDA can do, the groups call for prioritizing the biosimilars program (including by hiring new biosimilar experts), minimizing duplication or unnecessary studies during development and aggressively and immediately countering biosimilar misinformation and fearmongering.

“If biosimilars cannot compete fairly, we will continue to have single-market entrants with no competition to drive down costs to all stakeholders,” the report adds.

Structural Market Changes Needed in U.S. to Achieve Cost-Savings from Biosimilars


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