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Norway to facilitate switch to biosimilars with $3m Remicade study

By Dan Stanton , 06-Dec-2013
Last updated on 30-Mar-2016 at 13:14 GMT2016-03-30T13:14:39Z

Norway to facilitate biosimilar uptake with Remicade/Inflectra study
Norway to facilitate biosimilar uptake with Remicade/Inflectra study

The Norwegian Health Department has committed 20m NOK ($3.3m) to a study in order to facilitate the use of biosimilars.

Sixteen biosimilar products are currently authorized by the Europeans Medicines Agency (EMA) but now a Norwegian comparison study of monoclonal antibody drug Remicade and its recently approved biosimilar Inflectra will focus on switching from originator to biosimilar to increase the uptake of these drugs.

Switching from the branded drug to its biosimilar is “not a part of the European approval,” Steinar Madsen, Medical Director of the Norwegian Medicines Agency told, and therefore “it is important to collect more scientific knowledge in this matter.”

This will “increase physician and patient confidence,” he said, and “eventually facilitate switching.”

The study will be carried out by Norwegian regional health trusts with 20m NOK worth of funding. “This is entirely a Norwegian initiative,” Madsen added, “but I think that the results will be of great general interest.”

However, the study is still in its early planning phase and Madsen was unable to provide further details but he told us “the uptake of biosimilars in patient groups with long lasting treatments will be limited to new patients unless there is a switch.

“The Norwegian national hospital tender for TNF-inhibitors will be made public January 21th 2014. If the price is considerably lower than the originator, savings for the health care system will increase dramatically with switching.”

US Biosimilar Battles

Biosimilars may have entered markets such as Europe and India though studies such as this one show there is still some hesitation as to clinician and patient uptake.

In the US - where currently no biosimilars have been approved - debate has been raging over future approvals with proposed laws restricting their use and questions regarding nomenclature.

Furthermore, the hostile climate is likely to continue as the US begins coming aboard in the next couple of years, according to Foley & Lardner lawyer Dave Rosen at this year’s AAPS in San Antonio, Texas.

“There is not a lot of guidance on what is ‘highly similar,’ what constitutes minor differences and what are not clinically meaningful difference,” he said. “Those are inexact terms and so the onus is going to be on the companies that are going in to demonstrate that their product does not have any clinically meaningful differences.”

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