Sandoz: ABN for natalizumab biosimilar ruled promotional pre-authorisation (AUTH/3768/5/23)

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Key facts

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Case	AUTH/3768/5/23
Parties	Health professional v Sandoz Limited
Issue	Alleged misleading promotion of natalizumab prior to receiving marketing authorisation (ABN materials for a natalizumab biosimilar)
Materials	Full ABN slide deck and 2-page summarised ABN document
Therapy area	Multiple sclerosis
Applicable Code	2021
Complaint received	11 May 2023
Case completed	23 February 2024
Appeal	No appeal
Breach clauses	Clause 3.1 (x3); Clause 5.1; Clause 6.2
No breach clauses	Clause 2; Clause 3.1 (x4); Clause 6.1; Clause 6.3; Clause 11.1 (x5); Clause 14.1; Clause 14.4
Notable case note	Sandoz confirmed it will no longer accept PMCPA jurisdiction; did not accept breach rulings but did not appeal; complainant and MHRA informed.
Sandoz jurisdiction withdrawal date	18 October 2023

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

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A neurologist complained about Sandoz advance budgetary notification (ABN) materials (a full slide deck and a 2-page summary) for a natalizumab biosimilar for multiple sclerosis, before UK marketing authorisation.
The complainant alleged the materials were effectively selling the product to clinicians/pharmacists and included: biosimilar “state-of-the-art”/cost/expertise messaging; Phase III data with strong headings; claims about affordability/reinvestment; and package elements (JCV testing).
Sandoz said the materials were non-promotional ABN content aimed only at budget holders, supported by training, an “advanced notification confirmation form”, and that pricing was presented as a corridor (30/40/50%) because list price was not set.
The Panel assessed both the full deck (13 content slides) and the summary document, noting the complainant appeared to have access to both.
The Panel accepted ABNs for biosimilars can be appropriate in principle, but found parts of these materials went beyond what is permitted for ABN and amounted to promotion prior to marketing authorisation.
After the complaint was received, Sandoz confirmed it would no longer accept PMCPA jurisdiction; it did not accept the Panel’s breach rulings but did not appeal. The complainant and MHRA were informed.

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Breach found: ABN materials (in parts) did not meet ABN requirements and amounted to promotion prior to marketing authorisation.
Breach found: an “affordable… expand patient access and enable reinvestment opportunities” statement was ruled incapable of substantiation.
No breach found for: mention of similarity to reference product; Phase III content in the summary document (as presented); inclusion of JCV testing; timing of ABN; use of pricing corridors; omission of administration-method cost information; and Clause 2.
No appeal.

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Breach of Clause 3.1 (x3) Promotion of a medicine prior to the grant of its marketing authorisation
Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 6.2 Making an unsubstantiated claim
No Breach of Clause 2 Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 3.1 (x4) Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation
No Breach of Clause 6.1 Requirement that information/claims/comparisons must not be misleading
No Breach of Clause 6.3 Requirement that all artwork must conform to the letter and spirit of the Code
No Breach of Clause 11.1 (x5) Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation
No Breach of Clause 14.1 Requirement that comparisons must not be misleading
No Breach of Clause 14.4 Requirement that exaggerated or all-embracing claims must not be made

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