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PMCPA Case

Bayer v Novartis: Misleading comparative safety messaging at Lucentis symposia (AUTH/2748/2/15)

📅 8 March 2026 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2748/2/15
PartiesBayer plc v Novartis Pharmaceuticals UK Ltd
Product(s)Lucentis (ranibizumab) and Eylea (aflibercept)
Therapy areaOphthalmology (nAMD and DME)
SettingEURETINA congress, London (11–14 September 2014)
Symposium A“Forging the future in nAMD: The role of anti-VEGF and novel therapeutic targets” (13 September 2014, 1–2pm), attended by 965
Symposium B“Optimizing benefits and risks in DME” (11 September 2014, 1–2pm), attended by 633
Main issuesMisleading comparative safety impression; lack of contextualisation of claims-database analyses; incomplete disclosure of study sponsorship; SPC-inconsistent implication of dosing flexibility
Applicable Code year2014
Complaint received12 February 2015
Case completed24 June 2015
AppealNo appeal
Breaches3.2, 7.2 (x3 ), 7.3 (x2), 7.4, 7.9 (x2), 9.1
No breach2, 7.2, 7.4, 7.10
SanctionsUndertaking received; Additional sanctions: Not stated

Download the full case report (PDF)

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

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What happened

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  • Bayer complained about claims made by Novartis Pharmaceuticals UK Ltd at two Novartis Pharma AG-sponsored symposia at the EURETINA congress in London (11–14 September 2014) comparing safety of Lucentis (ranibizumab) vs Eylea (aflibercept).
  • Symposium A (nAMD; attended by 965): A section on “New data on ocular safety” presented retrospective US payor insurance claims analyses (Kelly et al/VERO and Kiss et al) suggesting higher endophthalmitis/severe intraocular inflammation claim rates with Eylea vs Lucentis, without adequate contextualisation against limitations, clinical trial data (eg VIEW 1/2), or SPC frequency context.
  • In Symposium A, slide 13 (“Introducing the new ranibizumab EU label…”) implied broad dosing/monitoring flexibility (“Mandatory monthly monitoring no longer required; now based on clinical need”) without making clear that flexibility applied only after initial monthly treatment until stability, as per the Lucentis SPC.
  • In Symposium A, disclosures stated “VERO study was sponsored by Novartis” but did not disclose that Kiss et al was sponsored by Genentech (commercially interested party), potentially implying independence.
  • Symposium B (DME; attended by 633): Across three talks and Q&A, the overall impression was that Lucentis had a more favourable systemic safety profile than Eylea in DME, with emphasis on molecular differences (Fc fragment) and systemic exposure, and suggestions that these differences would translate into clinically meaningful safety differences.
  • Bayer also alleged Clause 2 (industry disrepute) and raised concerns about “optimal outcomes” wording on slide 13 as a superlative/hanging comparison.
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Outcome

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  • The Panel ruled both symposia promoted Lucentis.
  • Breach: Symposium A endophthalmitis comparison was not sufficiently complete, was misleading, and did not reflect all available evidence.
  • Breach: Slide 13 overstated/unclearly presented dosing flexibility and was inconsistent with the Lucentis SPC.
  • No breach: The phrase “optimal outcomes” on slide 13 was not ruled a superlative/hanging comparison and was considered substantiated by the Lucentis SPC.
  • Breach: Disclosure was misleading because it disclosed Novartis sponsorship of VERO but was silent on Genentech sponsorship of Kiss et al.
  • Breach: Symposium B’s overall “take home” message implied a clinically significant safety advantage for Lucentis vs Eylea in DME without sufficient data; the comparison and implied clinical difference were misleading and unsubstantiated.
  • Breach: High standards were not maintained.
  • No breach: Clause 2 was not breached; the Panel did not consider patient safety would have been put at risk.
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