Celltrion: representative’s unsubstantiated “cost neutral” NICE/TAG justification and failure to provide substantiation for Remsima SC

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Key facts

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Case number	AUTH/3864/12/23
Company	Celltrion Healthcare UK Ltd
Complainant	Lead pharmacist at a University Hospitals NHS Trust
Product	Remsima (infliximab) subcutaneous (SC)
Allegation	Alleged false claim about NICE approval/TAG status for infliximab SC and failure to provide substantiation
Channel	Virtual MS Teams meeting (not recorded) and follow-up emails
Meeting date	10 October 2023
Substantiation requested	12 October 2023 (email follow-up); chased again 28 November 2023
Applicable Code	2021
Breach clauses	17.2, 18.2
Panel’s key reasoning	TAG applicability likely, but the “cost neutral” justification was not substantiated; substantiation was not provided within 10 working days
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	28 November 2023
Case completed	04 March 2025
Appeal	No appeal

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

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A lead pharmacist at a University Hospitals NHS Trust complained about statements made by a Celltrion representative during an MS Teams meeting on 10 October 2023 (meeting not recorded).
The meeting discussed support for switching patients from infliximab IV to infliximab SC, including local funding/approval variability across ICBs.
The representative stated Celltrion had discussed the topic with NICE and claimed NICE said infliximab SC fell under the Technology Appraisal Guidance (TAG) for infliximab IV, allegedly because pharmacoeconomics were “cost neutral” vs IV.
When asked for this “in writing”, the representative referred the complainant to the BNF and said they would forward communications.
The complainant chased substantiation by email (12 October 2023) and again (28 November 2023) but did not receive it within the required timeframe.
Celltrion later confirmed it had no records of a direct discussion with NICE that could be shared; the statement was based on general NICE biosimilar principles referenced in a NICE Evidence Review.

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