Eli Lilly v UCB: Bimzelx leavepiece—in vitro MOA claims implied clinical superiority

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Key facts

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Case number	AUTH/3650/5/22
Complainant	Eli Lilly
Respondent	UCB Pharma Ltd
Product	Bimzelx (bimekizumab)
Material	Promotional leavepiece (Sept 2021 ref IL-P-BK-PSD-2100004; updated Nov 2021 IL-P-BK-PSO-2100004)
Main issue	In vitro/mechanistic and cytokine level claims presented in context implying clinical significance and comparative superiority vs IL-17A blockade
Applicable Code	2021
Clauses breached	Clause 5.1; Clause 6.1; Clause 6.2
Appeal	Yes (by UCB); unsuccessful—breaches upheld
Sanctions	Undertaking received; additional sanctions: Not stated
Complaint received	27 May 2022
Case completed	22 August 2023

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

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Eli Lilly complained about three claims in a UCB promotional leavepiece for Bimzelx (bimekizumab) aimed at dermatology health professionals (Sept 2021 leavepiece ref IL-P-BK-PSD-2100004; updated Nov 2021 IL-P-BK-PSO-2100004).
The claims were presented on an inside page focused on mechanism of action (with in vitro data) and were positioned next to/alongside strong clinical superiority messaging elsewhere in the leavepiece (eg, “Superior efficacy in pivotal and head-to-head studies with Bimzelx”).
The three challenged claims were:
- “Blocking IL-17A and IL-17F results in superior inhibition of inflammatory responses vs blocking IL-17A alone” (updated version: “In vitro blockage of IL-17A and IL-17F results in superior inhibition of inflammatory responses vs blocking IL-17A alone”).
- “BIMZELX provides more complete inhibition of the IL-17A and IL-17F pathway compared with blocking IL-17A alone”.
- “IL-17F levels are approximately 30-fold higher than IL-17A in psoriatic skin”.
UCB argued the page was clearly “in vitro”, aligned with Section 5.1 of the GB SPC, and that other evidence (including BE RADIANT vs secukinumab and NICE appraisal/NMA) supported clinical relevance.
The Panel and Appeal Board focused on the overall context, layout, prominence of “superior” wording, and the insufficiency of small footnotes to prevent an implied clinical superiority message.

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Breach found for misleading presentation and implied clinical significance/superiority from in vitro data.
Breach found for lack of substantiation for implied clinical superiority vs IL-17A blockade (including absence of comparative data for ixekizumab).
Breach found for failure to maintain high standards due to the combined use of claims, artwork, and inadequate qualification (eg, very small footnote).
UCB appealed; all breaches were upheld and the appeal was unsuccessful.

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