AUTH/3764/4/23: Bayer v Roche – “first and only” faricimab claims and implied added benefit in non-responders

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Key facts

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Case	AUTH/3764/4/23
Parties	Bayer v Roche Products Ltd
Medicine	Vabysmo (faricimab)
Therapy area	Ophthalmology (nAMD, DMO)
Materials	53-slide promotional slide deck; sponsored promotional supplement/consensus document in a named publication
Main issues	Misleading “first and only” claim implying special merit; unsubstantiated/implied comparative “additional benefits” claim in non-responders/partial responders; alleged off-label switching without loading (not upheld)
Applicable Code	ABPI Code of Practice 2021
Complaint received	25 April 2023
Case completed	13 January 2025
Breach clauses	Clause 6.1 (x2); Clause 6.2; Clause 14.1
No breach clauses	Clause 5.1; Clause 6.1 (in a different context); Clause 11.2
Appeal	Roche appeal; breach rulings upheld
Sanctions	Undertaking received; additional sanctions not stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Bayer complained about three faricimab (Vabysmo) promotional claims used by Roche in two materials: a 53-slide promotional slide deck and a sponsored promotional supplement (consensus document) in a named publication.
Slide deck claim (appeared twice): “The first and only bispecific antibody targeting two distinct pathways in nAMD and DMO”. One instance was on a timeline in an “Unmet needs” section (slide 5); the other was in a mechanism-of-action section (slide 12).
Supplement claim 1: “Bispecific Ang-2 and VEGF-A blockade may confer additional benefits in patients with nAMD considered non-responders and partial responders to anti-VEGF monotherapy” (unreferenced in the supplement).
Supplement claim 2 (switching without loading): “Alternatively, clinicians may decide to switch without loading…” (Bayer alleged this was inconsistent with the SmPC).
Roche appealed four breach rulings; the Appeal Board upheld the Panel’s breach findings.

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Breach of Clause 6.1 (x2) – Making a misleading claim (Panel rulings upheld at appeal).
Breach of Clause 6.2 – Making an unsubstantiated claim (Panel ruling upheld at appeal).
Breach of Clause 14.1 – Making a misleading comparison (Panel ruling upheld at appeal).
No Breach of Clause 5.1 – Requirement to maintain high standards at all times.
No Breach of Clause 6.1 – Requirement that information, claims and comparisons must not be misleading (this related to the second appearance of the “first and only…” wording in the mechanism-of-action section).
No Breach of Clause 11.2 – Requirement that promotion must be in accordance with the marketing authorisation / not inconsistent with the SmPC (re: switching without loading).

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