One of the first biologics is the hormone insulin. Since the 1980s, human insulin can be produced using living organisms. Today, more than 230 biologics are licensed in Germany alone. In addition to hormones such as insulin, these include, for example, vaccines, antibodies, anti-inflammatories or blood products such as coagulation factors. They play an essential role in the treatment of autoimmune diseases such as rheumatoid arthritis or cancer therapy. Common to these medicines is that their active ingredients are derived from biological substances. They contain, for example, cell components, proteins or genetically modified organisms.
The production of medicinal products from biological substances needs to be monitored more closely than that of chemical drugs because it always involves natural fluctuations. Therefore, biologics must ensure that each new unit of production (batch) of the drug is as capable as the one approved initially. Producers of biologics must, therefore, test each new installment, whether the drug still acts as it should.
What are biosimilars?
For some biologics now copycat preparations are available, called biosimilars. These are equivalent copies of an active substance. They are manufactured by other companies and are often much cheaper than the original.
Copycat drugs have long been standard in medicine. Until a few years ago, however, it was mostly identical copies of active substances in chemically produced pharmaceuticals, so-called generics. An example of this are the copies of the original drug “Aspirin”: Its active ingredient acetylsalicylic acid (ASA) distribute various drug manufacturers for a lower price under other trade names. A generic drug may not usually be marketed until patent protection of the original medicinal product has expired.
Biosimilars: similar, but not identical
Some manufacturers of biologics claim that it is unclear whether the copies are as effective and safe as their original. But this is not true: tests must ensure that there are no significant differences between biosimilars and the first medicines. They can almost always be exchanged without hesitation.
However, a completely identical copy of an active substance is only possible with chemicals, not with biological drugs. Biological materials are complex and can not be replicated 1: 1. However, the differences between the approved original and the copy must always be so small that they do not jeopardize the efficacy and safety of the medicinal product.
The manufacturer of a biosimilar must, therefore, prove that his product is sufficiently similar to the authorized original organic medicine: it must not differ more than any new batch of the innovative medicinal product.
How is it tested to see if biosimilars are the same as the original?
Authorization of medicinal products is regulated centrally in Europe by the European Medicines Agency (EMA). In addition to its effectiveness, the EMA assesses the safety and quality of a biosimilar before it is approved. She makes sure that there are no significant differences between the original drug and the biosimilar. Also, the dosage and application must be the same.
Part of the safety testing of a biosimilar is, for example, antibody tests. They are intended to guarantee that patients do not produce antibodies against the biological agent, because these can change its effect. Even after approval, the manufacturer must monitor the safety of the biosimilar.
Why are there biosimilars?
For new medicines, patent protection guarantees a manufacturer for a limited time that he can market his product without competition. At this stage, antibiotics are often costly.
The manufacturers of biosimilars do not have to repeat all studies for the approval of their funds. This lowers the development costs. Also, they are offered cheaper to compete with the originals. In this way, they help to reduce spending in the healthcare system without causing any disadvantages for patients.
What should be considered when changing to a biosimilar?
It is possible that the doctor may suggest switching from an original medicine to a biosimilar. You then have to inform extensively about biosimilars. At this doctor’s talk also possible fears or concerns can be addressed.
Before the change, it is clarified whether allergies or intolerances speak against the use of a biosimilar. The reason: Copycat drugs may contain excipients that are different from those of the original medicines.