Dutch Project To Monitor Safety Of Biosimilar Switching
This article was originally published in The Pink Sheet Daily
Executive Summary
National pharmacovigilance center will pilot a national system for monitoring switches among innovator drugs and biosimilars.
The Dutch government has taken another step in its efforts to promote the uptake of biosimilar medicines by asking the national pharmacovigilance center Lareb to pilot a national system for monitoring switches among originator drugs and biosimilars.
Health Minister Edith Schippers said that some €300,000 ($334,000) has been put aside for the project, whose aim is to monitor the safety of all biological medicines, including biosimilars.
"The new monitoring system should contribute to the responsible use of these cheaper alternatives," the minister declared. "We must keep an eye on how this is done in large groups of patients."
The Dutch have been backing the switch strategy for some time as a way of keeping down the costs of biological drug treatment. Last year the regulator, the Medicines Evaluation Board, became the first EU agency to formally clarify its position on biosimilar switching, saying that it was permissible provided it was done with the involvement of a health professional and that the patient was informed. It had previously held that patients should be kept on the same biological medicine as far as possible if they responded well to it clinically.
Lareb Director Agnes Kant said the project would begin in the autumn in five Dutch hospitals and all patients prescribed a biological medicine (originator or biosimilar) would be monitored. "Based on these experiences, we will work out a proposal for a national system whereby switching between biological products will be followed and confidence in biological products will be strengthened," Kant said.
According to Schippers it will be important to keep a close eye on any adverse events occurring with switching of patients, and "we intervene where necessary. This will contribute to better patient care, higher quality of life and affordability of healthcare," she said.
Law firm Hogan Lovells in the Netherlands said the move was in line with the health ministry's "vision" for improving access to medicines, which was published in February this year. The vision, Hogan Lovells said, was based around six themes: new business models, tackling high drug prices, appropriate use of biosimilars, creating a balance in pharmaceutical market structures, access to innovative drugs, and better information provision.
This vision contained a warning on the need to curb spending on biologicals. In the section on biosimilars, the ministry said that it "further intends to stimulate the use of biosimilars. If stimulating measures prove to be insufficient to increase the use of biosimilars, the MoH will consider limiting reimbursement of biological medicinal products."
Since the Dutch Medicines Evaluation Board issued its revised position statement on biosimilar switching in April last year, other agencies have followed suit, notably Finland and France. Earlier this month, the French regulatory agency ANSM said that while for reasons of safety and traceability it was "not desirable" to modify the initial prescription, growing evidence and experience meant that a position that "formally excludes all interchangeability during a course of treatment no longer seems justified" (Also see "France Relaxes Stance On Biosimilar Switching" - Pink Sheet, 6 May, 2016.).
[Editor's note: This article also appears in Scrip Regulatory Affairs. Pink Sheet DAILY brings selected complementary coverage from affiliated publications to our readers.]