Questions and answers (BS)

A video

EMA’s video

  • What is a biological medicine?

Biological medicine is a medicine whose active substance is made by a living organism. Biological medicines have become important treatment for many diseases such as cancers, diabetes, multiple sclerosis, heart attacks, stroke and autoimmune diseases such as rheumatoid arthritis. These medicines contribute significantly to successful treatment and improvement in patient`s quality of life.

Here are some biological medicines that you probably have heard of:

  • insulin, which is used to treat diabetes;
  • monoclonal antibodies, that are used to treat conditions such as cancer or arthritis;
  • vaccines.

  • What is a biosimilar medicine?

A biosimilar medicine is a biological medicine that is developed to be highly similar and clinically equivalent to an original biological product. It is not possible to produce an exact copy of an original biological medicine, because the active substance in a biological medicine is complex molecule and varies naturally.

Similarity to the reference medicine must be established based on a comprehensive biosimilar comparability exercise, such that they do not have any clinically meaningful differences from the reference medicine in terms of quality, biological activity, safety, efficacy and immunogenicity.

Normally, you will take or be given a biosimilar medicine in the same way as its reference medicine. The dose of the biosimilar medicine will also be the same as the dose of its reference medicine.

  • What is a reference biological medicine?

A reference biological medicine is biological medicine approved in the EU, which is chosen by a company developing a biosimilar as a reference for the head-to-head comparison of quality, safety and efficacy.

  • Are biosimilar medicines the same as generic medicines?

No. Biosimilar medicines are not the same as generic medicines, which contain active ingredients derived from chemical synthesis and are identical to the originator medicine. Biological medicines are derived from living cells or organisms and consist of large, highly complex molecular entities. Due to the variability of the biological system and the manufacturing process, biological medicines may show a certain degree of variation, even between different batches of the same biological medicine, be it originator or biosimilar. Hence, biosimilars are similar and not identical to the reference medicinal product. However, for biosimilars registered in the EU it is demonstrated, that such differences do not change the safety and efficacy of the medicine.

  • Do biosimilars have a quality, efficacy and safety profile similar to the reference medicinal product.

Yes, they do. A biosimilar medicine must meet the same quality standards as the reference medicine. In addition, biosimilar is approved to be therapeutic equivalent to the reference medicine, as it has to be established that it is just as safe and effective as the reference medicine.

  • Is it possible to switch from a biological medicine to a biosimilar?

Yes, it is. The doctor may decide to initiate a new treatment directly with a biosimilar or to replace the biological medicine in use with its biosimilar (and vice versa), always providing the patient with the necessary information. The available switching data showed that single or multiple switches between the originator and its biosimilar versions had no negative impact on efficacy, safety and immunogenicity.

  • Does the interchangeability of biosimilars also cover situations where multiple switches are taking place – independent on frequency of switches and number of products involved?

Yes, if all switches are taking place within the group of products that has the same reference product, or between the reference product and its biosimilars. The comprehensive comparability exercise required for establishing biosimilarity makes negative consequences of switching highly unlikely. Such practice is already taking place in some EU member states without any signs of change in efficacy or safety for the patients. The interchangeability statement relates to the active substance and the formulated product and does not include potential issues related to handling of different devices (needed for administration) or physician or patient perception (of biosimilars). As for any biological, traceability should also be ensured for biosimilars to allow proper root cause analysis in case ADRs occur.

  • Does interchangeability – including the possibility for multiple switches apply to all kind of biosimilars, e.g., also those with a more complex molecular structure?

Yes, the EU regulatory and scientific requirements for establishing biosimilarity are tailored to meet the challenges posed by differences in molecular complexities thereby allowing for interchangeability of all EU approved biosimilars.

  • Does the joint HMA-EMA statement on interchangeability of biosimilars mean that switching to or between biosimilars are allowed in my country?

 No, EMA does not regulate prescribing practices or issues clinical guidance; these matters fall under national remit and are issued by the relevant bodies in each Member States. The statement on interchangeability of biosimilars is a general statement on the scientific principle highlighting that biosimilars can be used interchangeably and detailing the scientific references supporting this position. The statement is meant to advice those member states that want to allow for biosimilar prescribing, including any national decision on switching and/or (automatic) substitution. However, each Member State will decide on how this is applied in their territories, e. g. which biological medicines are available for prescribing in their country and whether automatic substitution with biosimilars is allowed at pharmacy.

  • Is interchangeability of biosimilars allowed in Slovenia?

Yes. In Slovenia, as in several other European countries, the interchangeability between authorized versions of a given biologic medicine at the treatment initiation or during ongoing treatment is possible if it takes place under the supervision of physician. However, JAZMP does not include biologicals and biosimilars on the list of interchangeable medicinal products, as it classifies certain generic medicinal products, therefore, biological medicines are not allowed to be substituted at the pharmacy level without consulting a doctor.

  • How do I know if I have been prescribed a biosimilar medicine?

A list of biosimilar medicines approved by the European Commission are available at the tab: BIOSIMILAR APPROVED IN EU AND MARKETED IN SI. Click on the name of each biosimilar medicine to learn more about it. If you have any questions, talk to your doctor or pharmacist.

  • What should you do if you experience side effects?

If you think you have a side effect from your medicine, report it to your doctor, pharmacist or nurse.
You can also report side effects directly to JAZMP – LINK
When you report a side effect, please include the brand name and serial number of the medicine, if you know them. The serial number will be on the medicines box. This helps match the report to the correct medicine.

  • Are there benefits to being prescribed a biosimilar medicine?

Yes. Using biosimilars allows a larger number of patients to benefit from treatments based on biological medicines by using the same amount of resources.

Biological medicines have changed and improved the treatment of many serious diseases. But biological medicines are usually very expensive.

Biosimilar medicines encourage competition and may reduce the cost of biological medicines. This means that healthcare systems such can save money and be more efficient. Reducing the cost of biological medicines can help increase the access to innovative treatments to several patients.

The decision to prescribe a biological medicine for an individual patient, whether a reference or biosimilar medicine (or to change between the two), rests with the responsible prescriber in consultation with the patient. This should be in accordance with the approved indications on the summary of product characteristics (SmPC).

  • What do I need to know about the biological medicine I take?

You need to know the brand name of your medicine. This is very important! Knowing the brand name means that you can report side effects for the correct medicine. Your medicine comes with a patient information leaflet. You should read this leaflet. It contains important information for you. If you have any questions, talk to your doctor or pharmacist.

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