Criteria used in compiling the list

Criteria used in compiling the list

Principles for compiling the list of mutually substitutable medicinal products with marketing authorisation at the Finnish Medicines Agency.

Generic substitution in pharmacies and phases of legislation

Generic substitution is a practice in which a prescribed medicine is substituted by a more affordable interchangeable product at a pharmacy if such a product exists on the market. Generic substitution aims to promote cost-effective pharmacotherapy and reduce both taxpayers' and the state's pharmaceutical expenditure. The purchaser of the medicine does not need to separately request that the medicine be substituted with a more affordable one at the pharmacy. Instead, the pharmacy staff will offer such product on their own initiative to the extent possible.

Generic substitution benefits both the purchaser of the medicine and the society that pays the patient a national sickness insurance benefit for the medicine. Savings are achieved both by product substitution and increased price competition between pharmaceutical companies.

Generic substitution was introduced in Finland in April 2003. The reform of the Medicines Act in November 2005 brought changes to the definition of active substance, in that different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of the active substance can now be considered to be the same active substance unless there are significant differences between them in terms of their safety, efficacy or both. This means that different salts of the same active substance become interchangeable, provided they otherwise meet the criteria for interchangeability.

The legislative amendment of 2023 introduced a wider range of inhaled medicines used to treat asthma and chronic obstructive pulmonary disease within the generic substitution scheme. From the beginning of 2024, biological products – in which biosimilars form a significant and expanding product group – will also be classified as interchangeable products.  

Main principles of interchangeability

Products are grouped into interchangeable groups according to the following principles:

1) the products contain the same amount of the same active substance or different versions of the same active biological substance;

2) if the products are in a solution form, the concentration of the active substance is the same;

3) the pharmaceutical form is the same (see comments on pharmaceutical forms below);

4) the products are biologically and/or therapeutically equivalent and their administration devices, if any, are similar to the extent that, after the pharmaceutical staff at the pharmacy have given the purchaser of the medicine appropriate advice on how to use the device, the substitution can be carried out safely, and

5) the therapeutic width of the products and other safety factors allow the substitution

Exceptions to the guiding principles above are possible. The list of interchangeable products prepared by Fimea is updated quarterly and published on Fimea's website. That list contains reference products, generic products and biosimilar products that meet the criteria and have a marketing authorisation. Parallel import and parallel distribution products are usually interchangeable regardless of their pharmaceutical form or ATC class. All products with marketing authorisation and all package sizes are not available.

Differences in pharmaceutical form or between administration devices might not necessary affect substitutability

As a rule, substitutability is not affected by minor differences in e.g. packaging size or type, package opening or appearance or tablet size, shape or colour.

For products containing an administration device, the main principle is that products can be considered interchangeable if they represent the same pharmaceutical form and method of administration and the differences between the devices are not so major that patient safety would be endangered. For example, a pre-filled syringe and a corresponding pre-filled pen are not interchangeable.

As regards to the form of medicine, certain exceptions apply. For example, a capsule can be substituted with a tablet or vice versa.  If the administration device is a separate one that could use a pharmaceutical ampoule or a similar drug-containing component made by another manufacturer, the assessment of interchangeability will take into account whether the separate parts have been demonstrated to be compatible and whether the prerequisites for safe substitution are met in the pharmacy.

The prescriber of the medicine may forbid substitution for a specific patient on medicinal or therapeutic grounds if they consider that certain product properties (rheumatics-friendly closure, capsule size, excipient, administration device or other factor associated with administration, etc.) will affect either the usability of the medicinal product or patient compliance.

Medicines not suitable for generic substitution

Certain medicinal products are not included in the list of substitutable products, for example due to narrow therapeutic width or other specific reasons.  These medicines include warfarin, most antiarrhythmic medicines, antiserums, vaccines, antiepileptics with certain exceptions and short-acting insulins.  Nicotine products are not classified as interchangeable.

Product information might differ

The summaries of product characteristics (SPCs) and package leaflets for interchangeable products may differ somewhat. This due to the fact that the marketing authorisations for the products may have been granted through different marketing authorisation procedures and at different times, and the harmonisation of texts has not always been carried out. Some products have SPCs that are common to several EU/EEA countries, and such SPCs might contain somewhat more limited indications and more contraindications and warnings than those of older products. This rarely causes problems in actual treatment situations and can be handled when writing the prescription. In conclusion, products classified as interchangeable are equally usable despite the despite the textual differences.

The list is updated quarterly and published on the Fimeas website.