update - Hospira regrets non-compliance

Pfizer unit Hospira and Napp broke APBI code during Remsima push

By Gareth Macdonald contact

- Last updated on GMT

iStock/alice-photo
iStock/alice-photo

Related tags: Monoclonal antibodies, Pharmacology

Pfizer’s Hospira unit and Napp Pharmaceuticals broke ABPI rules covering the promotion of biosimilar medicines according to the UK industry group.

The Prescription Medicines Code of Practice Authority (PMCPA) announced the transgressions today, explaining that Hospira and Napp will be named in adverts over the next few weeks.

According to the PMCPA, Napp​ made “unacceptable payments​” to doctors who attended a meeting at which Remsima (infliximab) – a Remicade biosimilar Hospira licenses from Celltrion – which meant the event was “was not a genuine advisory board​.”

Napp – an associate of Mundipharma International - launched Remsima in the UK on February 25​, 2015, just a day after Remicade's patent expired.

Remsima is a biosimilar version of Remicade (infliximab) which is sold by Janssen in the US, Merck & Co in Europe and Mitsubishi Tanabe Pharma in Japan.

The monoclonal antibody (mAb) – which is used to treat autoimmune disorders - was one of several biosimilars licensed by Hospira in 2009.

Overseas meetings

Hospira​ broke Association of the British Pharmaceutical Industry (ABPI) rules by “holding a meeting outside the UK for UK health professionals which was not a genuine advisory board, where its biosimilar medicines were promoted​” according to the PMCPA.

PMCPA director, Heather Simmonds, told us both Hospira and Napp had signed undertakings not to repeat breaches of the ABPI code.

The organisation will name both organisations in adverts in the Pharmaceutical Journal on August 27, the British Medical Journal (BMJ) on September 3 and the Nursing Standard on September 7.

Response

Napp told us it takes its responsibilities under the ABPI Code of Practice very seriously and respects the findings of the PMCPA Panel and the Appeal Board.

"Napp has cooperated fully and constructively with the PMCPA and the MHRA following the ruling, including issuing a corrective statement to all UK healthcare professionals who attended the November 2015 meeting in London to inform them to the findings of PMCPA case."

The firm added that: "Working in healthcare carries a great deal of responsibility. Ensuring that we work ethically and with integrity is incredibly important to us and we endeavour to follow the ABPI Code of Practice in all our activities.”

Pfizer told us "Hospira respects the decision of the PMCPA concerning activities organised at its European manufacturing facilities in July 2015.

"The Company regrets that certain elements of these activities were not Code compliant, however, at no time did the Company intend for this to be the case. Hospira is committed to becoming a full member of the ABPI and to continue enhancing its processes and procedures to meet the highest standards of conduct, as outlined by the ABPI code​."

Related topics: Markets & Regulations

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