What are Biosimilar, alternative to biological drugs | Diseases and conditions.
A biosimilar is a medication that is similar to a biological agent that could replace in the treatment of a disease, even though it is not identical products, which use still generates some doubts.
Some biological drugs patent has already expired (and that of others is about to do so), so it is expected to increase the number of available Biosimilar, drugs developed with the objective of being very similar to their biological reference, in terms of quality, safety and efficacy, and offering a cheaper alternative, fostering competition and providing access to this type of treatment.
Biological drugs are those that are made using one or more active ingredients synthesized or derived from a biological source (microorganisms, such as bacteria, yeast and viruses, woven humans or animals...), as is the case with insulin, the erythropoietin or monoclonal antibodies. And for a biosimilar is considered a valid alternative to its biological medicine reference - or innovative drug - it has to go through a process of comparability, which is a comprehensive comparison between both products.
It is important to note that Biosimilars have the same characteristics as the generic. The latter have simpler chemical structures and are considered identical to their reference medications, although the active principle of a biosimilar and its reference drug is the same biological substance, both are subject to some degree of natural variability due to its complex nature and their production methods.
Safety and efficacy of Biosimilar medicines
Biosimilar medicines have the same quality, safety and efficacy profile that their biological reference
The European Medicines Agency (EMA) required that each drug Biosimilars, which intends to market show that its quality is similar to the reference and that there are no relevant differences between both products. In addition, the biosimilar must undergo clinical trials that allow to detect possible differences with the innovative, and that they will also serve to ensure its effectiveness and safety.
Both the biological drugs and biosimilars can induce an immune response in the patient - what is known as immunogenicity, that could influence both on security and on the efficiency of treatment; Therefore, before you replace a drug by a physician must assess risks and benefits, and the patient must communicate any adverse effect that experience.
However, experts say that Biosimilars presented the same profile of quality, safety and efficacy that their biological reference, have the same opportunities that they cause adverse effects or unwanted immune reactions, and after permission also undergo a process of pharmacovigilance that controls all of these possible effects.
As with the prescription of any medication, the doctor must take into consideration the characteristics of the patient, your medical history, and the stage of the disease, among other factors, to decide whether a biosimilar is most suitable treatment where appropriate.
Published for educational purposes
Some biological drugs patent has already expired (and that of others is about to do so), so it is expected to increase the number of available Biosimilar, drugs developed with the objective of being very similar to their biological reference, in terms of quality, safety and efficacy, and offering a cheaper alternative, fostering competition and providing access to this type of treatment.
Biological drugs are those that are made using one or more active ingredients synthesized or derived from a biological source (microorganisms, such as bacteria, yeast and viruses, woven humans or animals...), as is the case with insulin, the erythropoietin or monoclonal antibodies. And for a biosimilar is considered a valid alternative to its biological medicine reference - or innovative drug - it has to go through a process of comparability, which is a comprehensive comparison between both products.
It is important to note that Biosimilars have the same characteristics as the generic. The latter have simpler chemical structures and are considered identical to their reference medications, although the active principle of a biosimilar and its reference drug is the same biological substance, both are subject to some degree of natural variability due to its complex nature and their production methods.
Safety and efficacy of Biosimilar medicines
Biosimilar medicines have the same quality, safety and efficacy profile that their biological referenceThe European Medicines Agency (EMA) required that each drug Biosimilars, which intends to market show that its quality is similar to the reference and that there are no relevant differences between both products. In addition, the biosimilar must undergo clinical trials that allow to detect possible differences with the innovative, and that they will also serve to ensure its effectiveness and safety.
Both the biological drugs and biosimilars can induce an immune response in the patient - what is known as immunogenicity, that could influence both on security and on the efficiency of treatment; Therefore, before you replace a drug by a physician must assess risks and benefits, and the patient must communicate any adverse effect that experience.
However, experts say that Biosimilars presented the same profile of quality, safety and efficacy that their biological reference, have the same opportunities that they cause adverse effects or unwanted immune reactions, and after permission also undergo a process of pharmacovigilance that controls all of these possible effects.
As with the prescription of any medication, the doctor must take into consideration the characteristics of the patient, your medical history, and the stage of the disease, among other factors, to decide whether a biosimilar is most suitable treatment where appropriate.
Published for educational purposes
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