Sandoz Dumps UK Prescription Medicines Code of Practice Authority

Sandoz is withdrawing from the UK’s Prescription Medicines Code of Practice Authority (PMCPA) after being dinged for promotional wording of its biosimilar natalizumab in official documents presented before the drug received a national marketing authorization.

The PMCPA ruled that three claims in a slide deck presented during an advance budgetary notification (ABN) session and a later summary document “amounted to the promotion of natalizumab before the grant of a marketing authorization,” breaching several clauses in the group’s 2021 Code. But rather than accept the board’s rulings, Sandoz has withdrawn from it.

Sandoz said that neither the slide set nor the summary were intended to be shared outside the select target group. In fact, the company required a signed confirmation from anyone who requested either document, and then assigned a trained staff member to go through the documents to ensure they were read in the intended context.

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