Biologics and biosimilars

Biologics are medicines that are made using biological substances. For example, they may contain cell parts, proteins or genetically engineered organisms. Biological medicines have a much more complex structure than chemical medicines do.

The hormone insulin was one of the first biologics to be developed. Since the 1980s, human insulin has been produced with the help of living organisms. There are now about 300 approved biologics in Germany alone. In addition to such as insulin, these include vaccines, antibodies, and blood products like coagulation factors (clotting factors). Biologics play an important role in the treatment of autoimmune diseases such as rheumatoid arthritis, as well as in the treatment of cancer.

The production of medicines made from biological substances must be more closely monitored than that of chemical medicines because there may be natural fluctuations. So each new production unit (batch) of biologics must be proven to be just as effective as the one that was originally approved. This means that manufacturers of biologics must test samples of each new batch to find out whether they are effective.

What are biosimilars?

Some biologics are now also available as “imitation medicines” called biosimilars. These are highly similar copies of the original active ingredient – a bit like generic medicines. They are produced by other companies and are often much cheaper than the original biologic.

Biosimilars are just as effective and safe as the original medications are. Extensive testing is done to ensure that there are no significant differences between the two products. They can almost always be exchanged without any concerns.

Although it is possible to make completely identical copies of medicines that are produced chemically, that is not possible with biological medicines. The differences between the original and the copy always need to be so small that they don’t reduce the effectiveness or the safety of the medicine.

Because of this, the manufacturers of biosimilars must prove that their product is similar enough to the original approved biologic drug: It must not be any more different than each new batch of the original medicine.

Who monitors whether biosimilars are as effective as the original?

The European Medicines Agency (EMA) centrally governs the admission of pharmaceutical products in Europe. They assess the effectiveness, safety and quality of each biosimilar before it is approved. They also check for any significant differences between the original product and the biosimilar. The dose and way the medicine is applied must be the same, too.

Tests to check the safety of a biosimilar include antibody tests. This is supposed to ensure that patients don’t build up any antibodies to the biological substance because that could alter its effect. The manufacturer must also continue to monitor the safety of the biosimilar after it has been approved.

Why do biosimilars exist?

When manufacturers develop new medicines, the patent protection guarantees that they can market their product for a limited amount of time without any competition. Medicines are often very expensive during this phase.

Manufacturers of biosimilars don’t have to repeat all of the studies that are needed for the approval of new medicines. This lowers the cost of development. Another reason why biosimilars are sold at a cheaper price is so that they can compete with the original medicines. In this way, they help to lower health care system expenses without creating any disadvantages for patients.

What should you take into consideration when switching to a biosimilar?

Your doctor may suggest using a biosimilar drug or switching from an original medicine to a biosimilar. They should then explain to you in depth what biosimilars are. When you talk with the doctor, you can also bring up any worries or concerns that you might have.

Before switching medicines, the doctor will determine whether you have any allergies or intolerances that would be reasons not to use the biosimilar. That is because generics may contain additives that differ from those in the original products. These additives are used to increase the shelf life and stability of the medicine, for instance, but don’t influence its effectiveness.

To be absolutely sure that a biosimilar has the same effect as the original medicine, patients who switch from a biologic to a biosimilar are monitored for a while at first, as they would be if they started using a biologic drug. So far, there are no known problems caused by switching to biosimilars, though.

And what are bioidenticals?

Bioidenticals (bio-identicals) are biological medicines that are made using the same production processes that are used for the original biologic drug. So they aren’t just similar – like biosimilars – but contain the exact same active ingredients and additives as the original products do. Original medicines and the corresponding bioidentical medicines are made by different companies and have different names, though. This is meant to ensure that the biological medicine is always readily available.

Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ). Empfehlungen der AkdÄ zur Behandlung mit Biosimilars. 2021.

Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ). Leitfaden: Biosimilars. 2021.

Bundesministerium der Justiz und für Verbraucherschutz (BMJV). Gesetz über den Verkehr mit Arzneimitteln (Arzneimittelgesetz - AMG). 2021.

Europäische Kommission. Was ich wissen sollte über Biosimilars. Informationen für Patienten. Konsensinformationsdokument. 2016.

Gemeinsamer Bundesauschuss (G-BA). Richtlinie über die Verordnung von Arzneimitteln in der vertragsärztlichen Versorgung (Arzneimittel-Richtlinie / AM-RL). 2022.

Von Schwerin A, Stoff H, Wahrig B. Biologics. A History of Agents Made From Living Organisms in the Twentieth Century. New York: Routledge; 2013.

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Updated on February 8, 2023

Next planned update: 2026


Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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