Information on biosimilar medicines for patients 2016

 

 

This article has been written for patients who want information about biosimilar medicines(1). Its purpose is to answer some of the questions that patients may have about these medicines. If you want more information on this topic, you will find references at the end of the article for further reading.

 

What is meant by biological medicine?

 

In general, we think that medicines are made with chemicals. However, biological medicines, including biosimilars, come from living organisms, such as living cells modified through biotechnology. This allows these cells or living organisms to produce the active ingredient of the biological medicine. This active ingredient is then extracted from the cells. These active ingredients (for example, proteins) are usually larger and more complex than those of non-biological drugs.

 

Biological medicines have been in development since the XNUMXs to treat a wide range of diseases. Available biological medicines include hormones, such as insulin and growth hormone, as well as monoclonal antibodies for the treatment of autoimmune diseases and cancer.

 

What is meant by biosimilar medicine?

 

A biosimilar medicine is one that has been developed to be very similar to an existing biological medicine. This existing biological medicine, called a reference medicine, is a medicine that has already been authorized and is used in the European Union (EU). Once the patent of the reference drug has expired and its exclusivity period has elapsed, it is allowed to market the biosimilar drug.

 

That they are very similar implies that the biosimilar medicine and its reference medicine are essentially the same, although there may be small differences in their active ingredients. These small differences are due to the fact that these active ingredients are normally large and complex molecules and that they have been obtained from living cells.

 

All biologics inherently carry some degree of variability, and small differences may exist between batches of the same biologic. Differences may also be seen when changes are made to the manufacturing process of a biological medicine. These changes are closely controlled by the European Medicines Agency. Any differences between the biosimilar medicine and its reference medicine have to be kept within strict limits to ensure that both medicines work in the same way.

 

The biosimilar medicine and its reference medicine can be compared to the leaves of a tree: they look the same and their purpose is the same, but if we look at them under a microscope there will be a very small degree of variation due to the fact that they depend on processes biological. However, biosimilar medicines undergo intensive scientific evaluation before they are placed on the market to ensure that, despite these small differences, the expected safety and efficacy are the same as those of the reference medicine.

 

Can biosimilars be considered as generics of biological medicines?

 

A biosimilar drug is not the same as a generic drug (a drug that contains exactly the same molecule as an existing non-biologic drug, such as aspirin). This is because, unlike non-biological medicines, biological medicines cannot be exactly copied (see explanation above).

 

Similarly, biosimilar medicines have no relationship with natural or complementary medicines, nor with medicinal plant medicines.

 

Why have biosimilar medicines been developed and approved?

 

Biologic medicines are treatments that can help patients with serious diseases such as cancer and inflammatory diseases. However, they are complex and can be very expensive and time consuming to develop. This can limit patients' access to this type of medication and make it difficult for healthcare systems to afford them. Biosimilar medicines can improve patient access to this type of treatment and are expected to be less costly for healthcare systems in the European Union mainly for two reasons:

 

• The development of biosimilar medicines is based on the scientific knowledge obtained with the reference medicine, so it is not necessary to repeat all the clinical studies carried out with the reference medicine.
• When they are introduced on the market, they must compete with the reference medicine. Typically, this means that biosimilar medicines will be offered at a lower price.

 

However, biosimilars are not simply "low-cost copies" of reference medicines. Biosimilar medicines are manufactured following strict quality requirements, using the most up-to-date methods and manufacturing plants that are inspected just like other medicines. Biosimilar medicines have been safely used in the EU as an alternative to reference medicines since 2006.

 

How are biosimilar medicines developed and approved in the European Union?

 

The European Medicines Agency (EMA) evaluates biological medicines produced through biotechnology, including biosimilar medicines, before they can be approved and marketed in the EU.

 

The authorization of biosimilar medicines in the European Union requires a different series of data than that of other biological medicines. However, the same strict standards of quality, safety and efficacy apply.

 

As with any other medicine, the benefits of a biosimilar medicine must be shown to outweigh its risks before it is approved for marketing.

 

This requires a large amount of data, including data on its purity and manufacture, on the correct performance of the biosimilar medicine and an extensive comparison with the reference medicine. Comparisons are made in stages, beginning with detailed laboratory studies comparing structure with function of drugs, followed by comparative clinical studies (human studies) as necessary. After the positive evaluation of the EMA, the European Commission approves the use of biosimilar medicines in patients in the European Union.

 

Why are not all the studies of the reference medicine repeated with the biosimilar medicine?

 

Since the safety and efficacy of the reference medicine are already well known, if the structure of the biosimilar medicine is very similar and its biological activity is the same, it is not necessary to repeat all the clinical studies. Instead, the purpose of the studies is to demonstrate that there are no clinically significant differences between the biosimilar medicine and the reference medicine (ie to demonstrate its biosimilarity).

 

Why is it possible to approve biosimilar medicines for indications for which clinical studies have not been carried out? What is “read-across”?

 

Given the way biosimilar medicines are developed (see above), it is not always necessary to conduct clinical studies with the biosimilar medicine in all indications for which the reference medicine has been shown to be effective. Instead, it is possible to extend the safety and efficacy data from studies from one indication to another. This is what is known as extrapolation. The European Medicines Agency (EMA) is the one that, on the basis of scientific evidence, decides in each case if new clinical studies are necessary to treat the rest of the indications.

 

Who decides if biosimilar medicines are available in specific countries?

 

Once the EMA has carried out a thorough scientific assessment of the quality, efficacy and safety of biosimilar medicines, the European Commission can authorize their marketing throughout the EU. From then on, availability depends on the company deciding to introduce the drugs to the market. The availability also depends on the joint decision with the national authorities on medicines and their respective Health Services of each country of the European Union.

 

I and my healthcare professional are considering choosing a biosimilar medicine for my treatment: will it be safe and effective?

 

Like any medicine approved in the EU, biosimilar medicines can be expected to be safe and effective therapeutic options as long as they are used appropriately in the approved indications. Instructions for use are provided both in the technical data sheet (for doctors and other health professionals) and in the patient information leaflet.

 

As with any treatment, it is important to have an in-depth discussion with the prescribing physician about the available therapeutic options, their safety, risks and benefits, as well as the differences between medications, before making a decision.

 

If I am already being treated with a biological (reference) medicine, can I be switched to the corresponding biosimilar?

 

It is possible to switch from a reference biological medicine to a biosimilar medicine, and this is an increasing practice in certain member states. Any therapeutic interchange decision (switching from one drug to another) must be made by your doctor in consultation with you and taking into account any possible established practices on the use of biological drugs in your country.

 

For any questions regarding switching from one biological medicine to another, patients should consult their doctor, pharmacist or specialist nurse.

 

Obtain information on the treatment and use of biosimilar medicines

 

As a patient who is going to be treated with a biological medicine, it is important that:

 

• Be fully informed of what to expect when starting treatment with a biological medicine or when switching from one biological medicine to another, which could be a biosimilar medicine;
• Get all the information you need about the medicine from your doctor or pharmacist. As with all biologic medications, a record must be kept of which medication has been administered to you.
• Participate in the decision about your treatment plan.

 

Like any medicine, biological medicines, including biosimilars, must be used appropriately. Patients may have a variety of questions about the way the medicine is given to them, and whether they should be aware of any precautions or restrictions during treatment.

 

The answers to these questions will depend on the specific medication prescribed for you and your health and medical condition.

 

Before starting your treatment with a biosimilar medicine, please read the patient information leaflet provided with the medicine. This leaflet contains important information on how you should use the medicine. To ensure that patients understand which medicine they are being prescribed, especially if they are switching from a reference medicine to a biosimilar, it is important that patients understand that all regulatory bodies have recommended that all biological medicines, including biosimilars, are prescribed by trademark and not by active ingredient. This recommendation is supported by patient organizations and healthcare professionals across Europe. If you still have questions or concerns about your treatment, talk to your doctor or pharmacist to make sure you have all the information you need.

 

What should I do if I suspect that I am experiencing a side effect?

 

As with all medicines, if you suspect you are having side effects, you and your doctor or pharmacist should notify you. This allows authorities to continuously monitor drug safety among the general population. You can obtain more information on the website of the European Medicines Agency or the Spanish Agency for Medicines and Health Products (AEMPS).

 

At the time of writing this document, no specific safety concerns have been identified for currently approved biosimilar medicines.

 

Your role as a patient

 

It is important that you report any suspected medication side effect to your prescribing physician, just as you would with any other medication. Also, you should tell your doctor if you think the medicine is not working. Sometimes side effects develop after a person has been taking a medication for a long time, or even when they stop using it. Reporting your symptoms to your doctor will not only help you feel better sooner, but also contribute to the ongoing evaluation of medication quality and safety.

 

You can also report your symptoms directly to the drug authorization authority in your country. Your doctor or pharmacist will be able to give you information on how to do this. If not, you can refer to the reference at the end of this document, “More information about reporting side effects”.

 

The role of your doctor or pharmacist

 

To report suspected side effects, your healthcare professional must correctly identify the medication and document the brand name of the medication prescribed in your patient file. You should then report the case to the relevant authorities, who will use the data to check whether the effects are due to the medicine and what measures should be taken. It is important for the healthcare professional to report side effects of biosimilar medicines, even if they are the same effects as those seen with the reference medicine.

 

For more information about your biosimilar medicine

 

If you have been prescribed a biosimilar medicine and would like more specific information about that particular medicine, you can go to the EMA website. You will be brought to a page where you can see information such as the SmPC and Patient Information Leaflet (in the 'Product Information' tab) or a summary of why this medicine has been authorized (in the 'About' tab). »).

 

What biosimilar medicines are approved in the European Union?

 

This link lists all the biosimilar medicines that are currently approved in the European Union. This information will be updated as new biosimilar medicines are approved.

 

Additional sources of information

 

The information contained in this brochure is based on a consensus document agreed by the multilateral working group on Market Access and Penetration of Biosimilar Products, and adopted by the steering group of the Process on Corporate Responsibility in the field of pharmaceutical products. The full version of the consensus briefing document is available here.

 

European Medicines Agency on:

 

Biosimilars
Drug safety control
Side effect notification

 

For more information see the websites of these patient organisations:

 

European Patients Forum
International Alliance of Patient Organizations
National Rheumatoid Arthritis Society (UK)
Danish Organization for Crohn's Disease and Colitis
Crohns and Colitis (UK)
Deutsche Morbus Crohn / Ulcerative Colitis Vereinigung
EULAR Directory of Organizations of People with Rheumatoid Arthritis in Europe (PARE)

 

(1) This brochure is an update of the "Questions and answers for patients" document that was published in 2013 as part of the consensus information document "What you should know about biosimilar medicines" (http://ec.europa.eu /DocsRoom/documents/8242/attachments/1/translations).

Disclaimer Clause

 

This document must be understood without prejudice to any existing or future national, European or international laws.

 

The informative consensus document on biosimilar medicines is written by and for patients in collaboration with the European Medicines Agency, the European Commission and its main stakeholders (European Patients Forum (EPF), the European Federation of Crohn's and Ulcerative Colitis Associations ( EFCCA), Committee of European Physicians (CPME), European Federation of Innovative Pharmaceutical Industry (EFPIA), European Association of Bio-industries (EuropaBio) and Medicines for Europe The European Commission would like to thank Emma Woodford (independent consultant) for her collaboration in editorial and coordination of the document.