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What are biosimilars?

More and more patients are receiving an offer from their doctor to use a "biosimilar" instead of their usual drug. However, the doctor does not always explain exactly what a biosimilar is and what the advantages and disadvantages are. Pharmacists also often don't know exactly how to explain to a customer what a biosimilar is.

As a rule, a drug is covered by a patent that has a certain term. Once this patent period has expired, other pharmaceutical companies can copy the active ingredient of the drug without fear of legal consequences. If the drug is a biopharmaceutical, this copycat product is called a "biosimilar." A biosimilar is a copycat drug that has been produced biotechnologically and - unlike other drugs, not biological drugs - is protein-based. Unlike generics, for example, which must match the original active ingredient, modest chemical differences are permitted for biosimilars as long as efficacy is proven. In this case, the approval regulations are not as strict as for chemical drugs or the original active ingredient.

Of course, biosimilars must also undergo series of clinical trials that demonstrate their efficacy and tolerability. In addition, biosimilars must also be officially approved. In the EU, this is done by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Patients to whom a biosimilar is proposed can therefore rest assured that only biosimilars officially approved in the EU are available on the market. Currently, about 20 biosimilars have received approval. Since biosimilars undergo rigorous testing in the areas of efficacy, quality and tolerability, more and more physicians are using this group of drugs at the start of a therapy. This is mainly because many patients report that the side effects are rather minor.

In practice, biosimilars are used, for example, to support cancer therapy and for kidney diseases (such as renal anemia). Another argument in favor of the use of biosimilars is that they are usually much less expensive than drugs with the original active ingredient. So although the medical efficacy has been proven and the financial advantage is also known, there are still few opportunities to use biosimilars. On the one hand, too few specialists are aware of the advantages of biosimilars, and on the other hand, there are few political incentives for health insurers and physicians to increase the use of this group of drugs, if possible and medically appropriate. However, there are signs of a clear improvement here, especially on the part of the health insurance funds.

Author: Niccolina. Translation. Image: stevepb / pixabay.