Your doctor has prescribed a biosimilar drug:
> What are its special features?
> Is it as effective and as well tolerated as other drugs?
> What are the advantages of using this type of drug?
What is a biosimilar?
A biosimilar drug is part of the family of drugs more broadly known as "biological drugs."
The French National Authority for Health (HAS) defines biosimilars as follows:
"A biosimilar drug is a drug which, like any biological drug, is produced from a cell, a living organism or derived from them."
Biologics and biosimilars: what are they?
A biological drug is "a substance that is produced from or derived from a living cell or organism". Examples include vaccines, growth factors and blood-derived drugs.
Biological drugs have revolutionized the treatment of many diseases, including diabetes, cancer, autoimmune diseases (such as multiple sclerosis, rheumatoid arthritis, etc.) and congenital diseases.
A biosimilar drug is similar to a biological drug already in use and authorized in Europe. The principle of biosimilarity applies to any biological drug whose patent has fallen into the public domain*. The physico-chemical and biological properties, pharmaceutical form, efficacy and safety are therefore identical to the original biological drug.
*As with any new drug, a patent protects new biologics from copying for a certain number of years. When their patent expires, they can be copied. These are known as biosimilar drugs.
Are they as effective and well tolerated as other drugs?
Before a biosimilar drug can be marketed, it undergoes a verification and marketing authorization process in Europe, and then in France. The list of authorized biosimilar drugs is available on the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) website. Verification of similarity is based on new preclinical and clinical trials, to ensure efficacy and tolerability, as well as the absence of serious adverse effects.
Once on the market (when they have obtained a Marketing Authorization or MA), a monitoring system is set up.
Can I prescribe either a biologic or its biosimilar?
Yes!
At the start of treatment, the doctor can choose either one or the other, with the same assurance of efficacy and safety. The doctor enters on the prescription the common name (INN) and brand name of the reference drug or the brand name of the biosimilar. In the event of supply difficulties, for example, the pharmacist can substitute an equivalent biological or biosimilar drug.
To continue treatment: it is advisable (but not compulsory) to prescribe the same drug. Physicians may, at any time, replace a biologic drug with a biosimilar from the list drawn up by the ANSM.
What are the advantages of using this type of medication?
According to the HAS, the use of biosimilar drugs allows :
- to "increase the number of biological drugs available by limiting supply tensions and preventing stock-outs and/or production accidents. This ensures that patients continue to have access to their treatments. There is therefore a direct, individual interest for the patient and, more broadly, a public health interest in facilitating access to care for all.
- to "stimulate competition and drive down the price of biological drugs, while guaranteeing the safety and quality of treatments". This is of considerable economic benefit to our healthcare system.
Further information
HAS_Bon usage du médicament_les médicaments biosimilaires. 2017.
Website: www. ansm.santé.fr
Video from the EMA (Eurpean Medicine Agency): https://www.youtube.com/watch?v=70sVGNVG7Jk