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Authorised medicinal product – biosimilar product

These instructions apply when the marketing authorisation holder is applying for the following for a biosimilar product:

  • reimbursement status and a reasonable wholesale price for the first time, and the reimbursement status is sought for the original product to the extent authorised for the original product
  • extension of the reimbursement status to the extent approved for the original product
  • renewal of reimbursement status and wholesale price

If you are applying for different reimbursement statuses for different packages of the same medicinal product and/or their therapeutic indications differ from each other, the indications and the reimbursement status you are applying for must be separately detailed for each package.

See also the general instructions for the application at applying for reimbursement status and reasonable wholesale price.

Application documents

  • Attach the following documents to your application:
    • valid summary of product characteristics
    • valid marketing authorisation decision (if the marketing authorisation was granted in a centralised authorisation procedure, also attach the information published by the European Medicines Agency on the different product packages and their marketing authorisation numbers)
    • sales volumes and number of patients
    • information on prices and reimbursement statuses in EEA states
    • clinical assessment by a marketing authorisation authority if you are seeking reimbursement status for a product for the first time or extension of the reimbursement status to the extent approved for the original product
    • any other specifications
  • Name the files as follows:
    • Summary of product characteristics
    • Marketing authorisation decision
    • Sales data and number of patients
    • Prices in EEA states
    • Clinical assessment
    • Name other attachments appropriately, for example: Source_Lastname_Year

The application must present grounds for the proposed wholesale price if the price proposed for the first biosimilar product exceeds the wholesale price approved for the original product by more than 70%.

Sales and number of patients

  • Estimate the future sales of the product at the proposed wholesale price and retail price including VAT per package and as total sales. Estimate the number of patients using the product. The estimate must be based on sales reimbursed under the Health Insurance Act and cover the current year and the four years following it.
  • In a renewal and extension application, include the sales estimates given in the previous applications as well as the actual sales during the period of validity of the decision and in the current year per package and as total sales of the product.
  • If the actual sales volumes differ significantly from the estimate given in the previous application, state the reasons for this difference and refer to a notification of exceeding sales submitted to the Pharmaceuticals Pricing Board.
  • Report the sales volume and patient numbers using the pre-formatted tables available on the website of the Pharmaceuticals Pricing Board.

Prices and reimbursement statuses in other EEA states

  • List any other trade names of the medicinal product used in other EEA states.
  • State the existing wholesale prices in euros, using the exchange rates valid at the time of submitting the application. If no wholesale prices are available, give the ex factory prices of the packages. Also provide this information on packages that are not sold in the Finnish market.
  • State if the product is reimbursed in other EEA states and if the reimbursement status is general or patient specific. Also give any restrictions and conditions for reimbursement.
  • Report the prices and reimbursement statuses in EEA states using the pre-formatted tables available on the website of the Pharmaceuticals Pricing Board.

This page was updated on 25 March 2026.