Generic Medicinal Products and Interchangeability
Questions and answers
What is generic medicinal product?
The generic medicinal product is a medicinal product containing same active substances in the same amount as the original medicinal product and it is presented in the same pharmaceutical form as the original one. Even though the generic medicinal product has a different name from the original one, the safety and efficacy of the generic and original one must be the same.
Is generic medicinal product of quality, safety and efficacy?
Yes. Generic manufacturers submit to the Agency for Medicinal Products and Medical Devices a comprehensive documentation stipulated by legislation, accompanying acts and EU guidelines. This documentation is assessed by the Agency experts in order to confirm the quality, safety and efficacy of generic product.
Are generic medicinal products tested in clinical trials on humans?
Yes. The bioequivalence study with the original medicinal product that must be carried out in order to grant marketing authorisation for generic medicinal product (registration) is a clinical trial on humans that demonstrates the same efficacy and safety of the generic and original medicinal product.
Does the Agency monitor generic medicinal products after granting marketing authorisation as it does for original ones?
Yes. The Agency monitors all adverse reactions and safe use of generic medicines in the same way as for original ones.
Why some generic medicines look different from the original medicinal product?
Except for the active substance which is responsible for the product's efficacy, every medicinal product contains additional ingredients, so called excipients that facilitate the preparation and administration of the medicinal product.
Excipients may be different as compared to the original medicinal product, however they must fulfil the same criteria of quality and safety as the excipients from original medicinal product.
Generic medicinal products may differ also in appearance from the original ones (i.e. different tablet shape or colour) and may be packed in different boxes, bottles and other packaging material from the original medicinal product.
The reason for these differences is due to manufacturing by different producers. Neither of these differences has an impact on the product's efficacy and safety, which is confirmed by the marketing authorisation granted by the Agency.
Are original and generic medicinal products interchangeable during treatment?
When the generic medicinal product demonstrates in a study the same bioequivalence with the original product, the benefits and risks of both medicinal products are considered equal and the generic medicinal product is considered interchangeable with original. (so called generic substitution).
However, there are generic medicinal products that may not be directly interchangeable with original medicinal products during the treatment of an individual patient, which means that they are not subject to classical generic substitution.
Medicinal products belonging to this group are:
- medicinal products of narrow therapeutic area and variable inter-individual absorption (i.e. cyclosporine, tacrolimus, warfarin, digoxin),
- medicinal products with more than two active substances,
- medicinal products with the same active substance administered by medical devices used in different ways.
The aforementioned medicinal products are interchangeable only in exceptional circumstances and exclusively based on recommendation of the doctor responsible for patient's monitoring during the treatment.
What are biological medicinal products and are there generic medicinal products (parallel products) of original biological medicinal products?
Biological medicinal product contains a biological substance as active substance, such as vaccines, medicinal product from human blood or plasma etc.
Biological active substances have a much complex molecular structure from synthetic medicinal products (medicinal products containing a chemical active substance).
Due to the aforementioned, it is not likely that a medicinal product may be produced with exactly same structure, active substances as the original one. However, it is possible to produce a medicinal product with completely identical structure of the active substance as the original one, which needs to be substantiated with additional studies to confirm its efficacy and safety in the marketing authorisation procedure.
These medicinal product are not called generic medicinal products but biosimilar medicinal products.
Due to the aforementioned, even though biosimilar medicinal products basically have the same clinical effect as the original biological medicinal products, these medicinal products are not directly interchangeable.
Active substances for which biosimilar medicinal products are authorised in the EU and HR are epoetin alfa, filgrastim, infliximab, somatropin, folitropin alfa and epoetin zeta.
Where else can I find information about medicinal product interchangeability?
The Agency will publish a list of interchangeable products as set out in the Medicinal Products Act (Official Gazette, No. 76/13) by the 1 January 2015. The list of interchangeable medicinal products will be available at the Agency webpages.