Finnish Biosimilar Substitution Proposals Get Pushback From Industry
Local Association Urges Government To Take A More Gradual Approach
Executive Summary
Finnish government proposals to introduce pharmacy-level substitution for biosimilars have been criticized by the country’s generics and biosimilars industry association.
Proposals set out by Finland’s government aimed at introducing pharmacy-level substitution for biosimilars have received a cool reception from the country’s off-patent industry.
According to the proposals set out by Finland’s ministry of social affairs and health as part of the country’s 2023 budget proposal, from 1 January 2024 the country will introduce “the generic substitution of biological medicines by pharmacies,” accompanied by the country’s reference-price system introducing reference price groups for original biologics and biosimilars.
The proposals form part of Finnish budgetary measures to improve the cost-effectiveness of pharmaceutical services and unlock savings that can be directed to other parts of the country’s health and care framework.
“Finland introduced generic substitution by pharmacies in 2003. The reference price system was introduced in 2009. The proposed amendments to the Medicines Act would make it possible to include biological medicines and biosimilars in the generic substitution scheme,” the government said, suggesting that brand biologics should replaced by eligible biosimilar equivalents within six months.
Addressing potential concerns over safety, the government notes that “pharmacies are already obliged to provide customers with information on medicines and prices when dispensing medicines to them. To ensure patient safety, pharmacies’ obligation to provide information would be supplemented so that pharmacies would be required to provide the buyer with information on medicines and medical devices when they replace a biological medicine or biosimilar.”
Additionally, the substitution of insulin products by pharmacies would be “introduced in stages over the course of two years to ensure medication safety,” the government proposes.
Meanwhile, Finland’s Health Insurance Act would be amended so that the reference price system would include reference price groups with original biologics and their biosimilar counterparts, with the reimbursement received by the medicine user paid “on the basis of the price charged for the medicinal product if the biological medicine or biosimilar was included in the reference price group and dispensed in accordance with the proposed regulation on generic substitution.”
Summarizing the goal of the proposals as being “to reduce the pharmaceutical costs incurred by medicine users and to cut central government expenditure on medicine reimbursements,” the Finnish government said that “by reducing central government expenditure on medicine reimbursements, it is possible to direct funding to wellbeing services counties and contribute to enabling central government funding for the minimum staffing level for care personnel.”
“The draft proposal was already widely criticized by most stakeholders and patient organizations, so we are quite surprised that the government is still pushing this forward without necessary changes.”
But responding to the biosimilar substitution proposals, Heikki Bothas, CEO of Finnish generics and biosimilars industry association Rinnakkaislääke, told Pink Sheet's sister publication Generics Bulletin that the industry group “supports rejecting or changing the proposal.”
“The draft proposal was already widely criticized by most stakeholders and patient organizations, so we are quite surprised that the government is still pushing this forward without necessary changes,” Bothas observed.
Noting that the Finnish Medicines Agency had previously defined seven preconditions to pharmacy substitution, Bothas said the current proposal “does not meet these conditions.”
“Substitution has to be implemented in stages,” Bothas cautioned. “We should start with one or two substances and the substitution interval should be one year instead of six months.”
Moreover, Bothas suggested, “all biological medicines are not necessarily suitable for pharmacy substitution. Patient safety should be the number one priority and concerns raised by patient organizations must be resolved.”
“The government has already failed to build trust,” Bothas concluded. “Biological medicines are used to treat serious diseases, so ensuring continuity of treatment and compliance with treatment is extremely important.”
While biosimilars are deemed therapeutically interchangeable in Europe – a position reinforced by a recent statement from the European Medicines Agency and Heads of Medicines Agencies (Also see "R&D Industry Finds Biosimilar Interchangeability Statement By EU Regulators ‘Concerning’" - Pink Sheet, 22 Sep, 2022.) – formal substitution mechanisms fall within the purview of national European authorities and remain relatively rare.
French efforts to introduce substitution for certain molecules have been in place since early this year, albeit for only a limited selection of molecules. (Also see "Stakeholders Surprised As French Biosimilar Substitution Changes Tack" - Generics Bulletin, 21 Apr, 2022.)