Interchangeable Biosimilars: The Central Path to Lower Biologic Prices?

Regulatory NewsRegulatory News | 19 July 2018 |  By 

With the first interchangeable biosimilars expected to come to market by 2020, anticipation has heightened on what kind of impact these products will have, particularly when competing with other non-interchangeable biosimilars.
But before that first advisory committee is announced, speculation has swirled on whether doctors will be prepared to understand the concept of interchangeability (what with the discussion on substitution and switching studies, and the lack of interchangeable products elsewhere in the world), or if interchangeables will lead to more significant savings than “regular” biosimilars (i.e. Ones that are not interchangeable).
Aaron Kesselheim, director of the Program on Regulation, Therapeutics and Law at Brigham and Women’s Hospital, explained to Focus: “The way the US market is structured, we are unlikely to get that much price competition from biosimilars alone. (Although certainly changes to the system that block legitimate ‘regular biosimilars,’ as you call them, should be addressed also.) Unless and until we change the way we pay for drugs more broadly, interchangeables are really the central path to real competition and lower prices.”
Others think interchangeability will only play part of the role in bringing down prices.
Ronny Gal, Bernstein analyst, told Focus: “I think interchangeability is a partial solution. Specially drugs can remain primarily branded even with interchangeability, see Copaxone. I would argue you need (1) payer system reform, (2) court ruling limiting market tie up and (3) interchangeability.”
Others in industry also do not necessarily think that so far, interchangeability has been the reason for biosimilars lacking success in gaining market share in the US (11 biosimilars have been approved but just three have come to market, some of which are still struggling to gain significant market share).
Heather Bresch, CEO of Mylan, explained to Focus at an Atlantic event on Tuesday in Washington, DC: “Interchangeability is an issue. I believe we’ve shown the science is there. The science for reproducibility and interchangeability is all there. I don’t believe the lack of uptake is because of interchangeability. It’s more to do with the way formularies are placing a generic or biosimilar and being able to block access.”
On FDA’s front, in January 2017, the agency released its draft guidance on biosimilar interchangeability for consultation, explaining to companies how they can establish interchangeability with switching studies, though companies sought further clarity. And two of the 11 tenets of FDA’s biosimilar action plan released Wednesday include finalizing the draft on interchangeability or revising it, and continuing to provide education on key concepts about biosimilar and interchangeable products.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy