Denmark addresses patients' qualms over biosimilars

16 June 2017
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Authorities in Denmark have put together a program designed to allay patient’s concerns over switching to biosimilars, in collaboration with the Danish Rheumatism Association.

The scheme, details of which were presented at the Annual European Congress of Rheumatology, or EULAR, in Madrid, may help to address concerns over a potential ‘nocebo’ effect, whereby negative expectations affect patient outcomes.

After the first biosimilar approval was granted in Denmark in 2015, 97% of new patients or those taking the reference product, Remicade, were switched to biosimilar infliximab.

A study revealed that although most patients were told about the change in their treatment, they received a lack of information from their doctors about the new biosimilars.

"In order to change this situation, we started a dialogue with politicians and the authorities on a national level and hospital administrations on a regional level," said Lene Mandrup Thomsen from the Danish Rheumatism Association.

"The purpose was threefold: to improve the registration of biologics and biosimilars on a batch-level, the provision of more independent patient information and the involvement of patients in the decision-making process," she explained.

The new national plan, launched in August 2015 and implemented throughout 2016, consisted of four parts:

  • Monitoring efficacy and safety of biologics and biosimilars on a batch level. 
  • Information campaign targeting both doctors and patients. 
  • Digital solutions to aid easy reporting of side effects.
  • Focus on monitoring patient safety.

US biotech major Biogen (Nasdaq: BIIB), which offers biosimilar infliximab under the trade name Flixabi, spoke with The Pharma Letter about the problem of patient adoption ahead of the EULAR conference.

Alpna Seth, head of biosimilars, said: “Different countries in Europe are in different stages of adoption, so it's important to share best practices.”

“There are lots of learnings from doctors and hospitals who have recognized this as a potential issue and have been able to provide guidance to patients and to educate them about biosimilars, about the fact that they are efficacious and just as safe as the bio-original, and that can have a tremendous impact.”

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