Biosimilars on the substitution list?

The Norwegian Ministry of Health and Care Services (“the Ministry”) has presented a proposal for amendments to the Norwegian Pharmacy Act section 6-6, suggesting that biosimilars (a biologic medicinal product similar to another already approved biological medicine) may be included on the substitution list. By this, biosimilars will be subject to automatic substitution in pharmacies in the same way as generic medicines. This will increase competition in the Norwegian market between the original biological medicine and the biosimilar medicine.

The proposed amendment is on public consultation ending September 30, 2020.

Current arrangement

At present, automatic substitution in pharmacies of biological or biosimilar products is not allowed. The current substitution list is reserved for generic and parallel imported medicines, and the common understanding in this respect is that biosimilars are not considered to be a generic to a biological medicine. This was confirmed in a first instance decision in 2011 regarding filgrastim (TOSLO-2010-128688), where the decision from the Norwegian Medicines Agency to include filgrastim on the substitution list was ruled to be invalid.

When the regulation came into force back in 2001, biosimilars did not exist. The first biosimilar medicine was granted marketing authorisation in 2006. The Ministry is of the opinion that there is no professional basis for maintaining such a limitation in the substitution list.

The proposal

The Ministry proposes to amend the regulation so that generic, parallel imported and biosimilar medicines can be included in the substitution list when these are considered bioequivalent. The Ministry assumes that when a biosimilar medicine is granted a marketing authorisation, it is a result of it having the same effect and safety profile as the original biological medicine.

When included in the substitution list, the Norwegian Medicines Agency can also decide that the biosimilar shall be subject to the stepped price model (“trinnpris”). This means that the price that will be reimbursed by the National Insurance Scheme will be gradually lowered in two or three steps. The pharmacies will be obliged to offer the patients at least one product at a price equal to the stepped price. This will lead to a substantial price reduction for medicines where there are biosimilar alternatives, leading to savings for both the National Insurance Scheme and the patients.

According to the Ministry, the purpose of the proposal is to facilitate that the substitution system can be managed in accordance with actual medical and regulatory developments, so that the potential for competition and lower prices on medicines can be realized to a better extent than today.