The fight for dominance between Regeneron and Bayer’s big blockbuster eye drug Eylea and Roche’s rival Vabysmo is playing out in arenas beyond just prescription counts and sales numbers.
In a recent ruling from the Prescription Medicines Code of Practice Authority (PMCPA), the U.K. drug marketing watchdog once again sided with Bayer—which markets Eylea outside the U.S.—in accusations that Roche made misleading and unsubstantiated claims about its competing eye disease med.
The spat dates back to 2023 when Bayer first filed a complaint with the body. In it, the drugmaker flagged several claims that Roche made about Vabysmo in various promotional materials. Bayer said it had “successfully resolved” several of its issues with Roche directly, but “there remain three promotional claims for faricimab [Vabysmo], involving two different promotional materials, where Bayer has been unable to reach agreement with Roche.”
One of the claims appeared twice in a promotional slide deck for Vabysmo and described it as “the first and only bispecific antibody targeting two distinct pathways in [neovascular age-related macular degeneration] and [diabetic macular edema].”
Bayer called that statement “misleading,” noting that “Roche may be technically accurate but only in their use of the word ‘antibody,’” as Eylea is a “fully human, recombinant fusion protein derived from an antibody” that also targets those two pathways. The company suggested that such a statement may lead readers to believe that Vabysmo is the first and only biologic treatment to treat the two eye diseases—despite the fact that Eylea became available in the U.K. nearly a decade earlier—and is therefore more beneficial than other treatments, a comparison that “has not been established,” per Bayer.
Though Roche disagreed, the PMCPA did side with Bayer that the claim was misleading and therefore in breach of Clause 6.1 of the agency’s code.
Bayer also took issue with claims made in a promotional supplement for Vabysmo, comprising a “clinical consensus by leading UK experts.” Though the PMCPA’s panel didn’t agree with all of Bayer’s alleged breaches of the code, it did rule that three breaches had occurred when Roche included in the promo the experts’ opinion that Vabysmo’s mechanism of action “may confer additional benefits” to patients who hadn’t previously responded to a monotherapy like Eylea—which Bayer said “remains an area of controversy and emerging scientific opinion.”
Once again, Roche denied that the claim was “misleading [or] incapable of substantiation,” but the panel concluded that it was “ambiguous” and could mislead healthcare professionals about the clinical significance of Eylea compared to competing therapies.
In September 2024, Roche appealed the four resulting rulings that it had breached the PMCPA’s code. In explaining the first statement, it said the “first and only” wording was used not to “directly indicate superiority, but it does imply that it is different.”
As for the second, Roche said the inclusion of the experts’ opinion was intended only to highlight a patient group that “MAY benefit from a therapeutic trial of faricimab, given that the response to date had been clinically sub-optimal” (emphasis Roche’s), and not to claim “superiority or comparison” to competing treatments.
The appeal was ultimately unsuccessful, as the PMCPA closed the case this month by upholding all four of its original rulings. As for any resulting sanctions, the agency noted that an “undertaking” had been received, referring to the required written statement from an offender describing how it plans to avoid any future breaches.