Samsung Bioepis: UK senior leader’s LinkedIn ‘like’ treated as promotion of unlicensed biosimilar (AUTH/3761/4/23)

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Key facts

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Case	AUTH/3761/4/23
Parties	Complainant v Samsung Bioepis
Issue	Alleged promotion of an unlicensed medicine on LinkedIn via a UK senior employee’s ‘like’ of a corporate post linking to product milestone news
Channel	LinkedIn post and linked corporate website “News Releases” webpage
Complainant	Concerned health professional
Applicable Code year	2021
Complaint received	05 April 2023
Completed	08 May 2024
Appeal	No appeal
Breach clauses	3.1, 5.1, 8.1
No breach clauses	16.1, 26.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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A concerned health professional complained about a Samsung Bioepis senior UK employee reposting and ‘liking’ a corporate LinkedIn post.
The post announced a positive CHMP opinion for a Samsung Bioepis haematology biosimilar (not named in the post) and linked to the company’s corporate “News Releases” webpage.
The linked webpage (as seen by the complainant) showed six news tiles; three were product milestone items for Samsung Bioepis biosimilars and included originator product names (generic and/or brand name).
The Panel considered that ‘liking’ content on LinkedIn can amount to proactive dissemination to the employee’s connections (822 connections, including likely members of the public), bringing the material within scope of the UK Code.
At the time of the ‘like’, Samsung Bioepis did not hold UK marketing authorisations for its biosimilars referenced on the linked webpage.
The Panel was concerned the senior UK employee had not received social media-specific training and that there did not appear to be a Code-related governance framework in place for the UK.

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Breach found for promoting an unlicensed medicine.
Breach found for failing to maintain high standards.
Breach found for failing to certify promotional material.
No breach found for requirements relating to internet promotion of prescription-only medicines to a UK audience (technical applicability point).
No breach found for advertising prescription-only medicines to the public (medicines were unlicensed at the relevant time).

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Breach of Clause 3.1 Promoting an unlicensed medicine
Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 8.1 Failing to certify promotional material
No Breach of Clause 16.1 Requirement that promotional material about prescription only medicines directed to a UK audience which is provided on the internet must comply with all relevant requirements of the Code
No Breach of Clause 26.1 Requirement not to advertise prescription only medicines to the public.

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