AUTH/2337/7/10: Merck Serono v Sandoz — Omnitrope press release and draft patient newsletter article | PMCPA Case

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Key facts

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Case number	AUTH/2337/7/10
Parties	Merck Serono v Sandoz
Product	Omnitrope (somatropin) (biosimilar); comparator context: Saizen (somatropin)
Materials	Global press release issued in Germany; draft article for a UK patient support group newsletter
Main issue upheld	Misleading statement implying NICE found “no differences in terms of safety or efficacy between the products”
Applicable Code year	2008
Complaint received	28 July 2010
Case completed	25 October 2010
Appeal	No appeal
Breach clause(s)	Clause 7.2
Sanction(s)	Undertaking received

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

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Merck Serono complained about a global Sandoz press release (issued from Germany) about Omnitrope (somatropin), a biosimilar growth hormone, referencing UK NICE guidance and NHS cost savings.
Merck Serono also complained about an article allegedly published in a UK patient support group newsletter (“Biosimilars, NICE and Omnitrope”).
The Panel decided the press release was subject to the UK Code because it discussed UK NICE guidance and referred to cost savings to the NHS; Sandoz was responsible under the Code.
Most allegations about “cost-benefit” wording, “least costly option” wording, clinician quote, and cost savings were not upheld.
One key claim in the press release stating NICE found “no differences in terms of safety or efficacy between the products” was found to misrepresent NICE’s position and was ruled misleading.
The patient newsletter article was found not to have been published or used; a draft had been circulated for comment and then withdrawn, so no breach was ruled for that material.

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Breach found: Clause 7.2 (misleading claim about “no differences in terms of safety or efficacy”).
No breach found for other challenged press release statements under Clause 7.2.
No breach found for the draft patient newsletter article (Clauses 2, 7.2, 9.10, 22.1) because it was not published/used and was in draft form.
Undertaking received.
No appeal.

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