MHRA Raises Concerns Over Improper Biosimilar Marketing

Regulatory NewsRegulatory News | 02 August 2016 |  By 

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway.

The meeting, entitled “Norway inflammatory bowel disease [IBD] exchange,” was intended by the privately held, UK-based Napp Pharmaceuticals to promote Remsima from 11-13 October 2015 for UK healthcare professionals. The meeting was ruled in breach of the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice following an anonymous complaint to the Prescription Medicines Code of Practice Authority (PMCPA).

“The meeting was found to be an inducement to prescribe or recommend Remsima because it was held outside the UK without a clear and cogent reason and was therefore found in breach of the Code by the Panel and the ABPI Appeal Board,” MHRA said.

Also at issue for the PMCPA was a Remsima marketing material calling for a switch from Remicade to the biosimilar Remsima. 


The UK prohibits the advertising of prescription-only medicines. Furthermore, all ABPI members are required to comply with the ABPI code as a condition of membership, and approximately 60 companies that are not members of the ABPI also have agreed to abide by the code.

The code is administered by the PMCPA, which operates independently of the ABPI, and adjudicates matters that are alleged to amount to a breach of the code. PMCPA also has the power to impose fines and a range of other sanctions in relation to breaches of the ABPI code, according to the UK law firm TaylorWessing.

MHRA and PMCPA Concerns

Following its reading of the ABPI report on the Norwegian meeting, MHRA says it “was concerned that healthcare professionals have been put in a position where their actions were potentially in breach of medicines advertising legislation.”

Napp, meanwhile, voluntarily agreed to issue a corrective statement to all UK healthcare professionals who attended the meeting, informing them of PMCPA's findings.

PMCPA also noted that the agenda for the meeting stated that the focus of the event was to share best practices on IBD treatments in both the UK and Norway, particularly as the cheaper Remsima had been available in Norway since January 2014 but not launched in the UK until February 2015.

“The meeting had been developed in response to feed-back from pre-launch advisory boards that real world evidence and experience from clinicians who had used Remsima was important. Biosimilar infliximab in Norway had a 63% market share. One of the stated aims of the meeting was to allow key opinion leaders to share real world experience with Norwegian clinicians who used Remsima in IBD given that clinical data in IBD patients and practical experience in the UK of using biosimilar infliximab was very limited. In the Panel’s view the meeting was organised specifically with a focus on Remsima and to promote switching from Remicade to Remsima in IBD,” PMCPA said.

The primary objective of the meeting, according to PMCPA, appeared to be an interest in allaying UK doctors’ concerns about switching IBD patients from Remicade to Remsima. The average total cost, including air fare, for those attending the two-day meeting was £799.73 per person.

PMCPA added: “When Remsima was launched in the UK (February 2015), clinical data in IBD and practical clinical experience with biosimilar infliximab was extremely limited. The Appeal Board further noted Napp’s submission that Norwegian clinics, however, had used Remsima since early 2014; the position by June 2015 was that Remsima was used for all new IBD patients nationally and several IBD centres had switched to 100% Remsima.”

The appeal board, however, said that because of the brevity of the tours of the two Norwegian hospitals (lasting in total 3.5 hours), and because there was already some UK experience of switching IBD patients from Remicade to the biosimilar infliximab, “there was no clear and cogent reason for the UK delegates to travel to Norway for the meeting.”

In June, Napp issued the following corrective statement to attendees of the Norwegian meeting:

“Dear HCP

Re: Remsima (infliximab): Two day Promotional Meeting for UK healthcare professionals held in Norway – PMCPA CASE AUTH/2795/9/15 & Potential breach of medicines advertising legislation

I am writing to you on behalf of Napp Pharmaceuticals Limited (Napp) as you were a delegate to the meeting held on 11-13th October 2015 in Oslo.

An anonymous complaint from a UK healthcare professional about the meeting was made to the Association of the British Pharmaceutical Industry (ABPI) Prescription Medicines Code of Practice Authority (PMCPA).

The complaint was investigated by the PMCPA and Napp was held to have breached the PMCPA Code of Practice (Code). In particular the PMCPA and the subsequent Appeal Board ruled that there was no clear and cogent reason for UK delegates to travel to Norway for the meeting, and that an alternative way could have been found to incorporate the Norwegian learning in to a meeting held in the UK. The Appeal Board considered that whilst the location of the meeting was unacceptable, the aim of the meeting was not unreasonable.

Whilst the PMCPA did not hold that the level of subsistence was excessive, it nevertheless found that holding a two day promotional meeting in Norway without a clear and cogent reason constituted an inducement to prescribe or recommend Remsima, in breach of the Code. The Appeal Board further upheld the ruling by the PMCPA Panel that high standards had not been maintained by Napp.

Napp have been asked to bring this case to your attention by the Medicines & Healthcare products Regulatory Agency. Acceptance of any prohibited benefit or hospitality would be a breach of Regulation 300(4) of the Human Medicines Regulations 2012.

Napp takes its responsibilities under the Code and Regulations very seriously. We recognise the finding of the PMCPA Panel and the Appeal Board that the location of the meeting was not acceptable. Nevertheless we believe Napp acted entirely in good faith and as a respected healthcare professional we sincerely regret having involved you in this matter.”

MHRA Decision



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