Pharmacists in France can now give ‘biosimilar’ drugs to patients for certain prescriptions after France allowed the practice – but this is not the same as ‘generic’ equivalents. We explain.
What is now allowed?
Pharmacists in France are now allowed to give drugs considered “biosimilar” to certain specific prescribed drugs, after a decree published in the government’s legislative publication, the Official Journal, on April 14.
Biosimilar medicines are effectively the same medicines (in terms of content and active ingredients) as the original brand, but are usually less expensive. There may be some differences in the ingredients, but they are intended to be used for the same treatment as the more expensive brand.
They are not the same as “generic” drugs, which are exact, unbranded chemical copies of the original drug. For example, Doliprane is a brand of paracetamol painkiller, but generic versions are simply labeled as the main ingredient, “paracetamol”, without a brand name.
On the other hand, biosimilar drugs are very close, but not always identical, copies of so-called “biological” treatments. They have their own brand and are often prescribed for the treatment of diseases such as diabetes, cancer, infertility or osteoporosis.
Are there rules on which drugs can be considered biosimilars?
Yes. For a drug to be considered a real substitute, it must be “authorized in Europe for eight years and that its patent has fallen into the public domain”, specifies the National Agency for the Safety of Medicines and Health Products. health. (ANSM).
Which drugs can now be replaced by biosimilar equivalents?
A total of 16 drugs are included in the new decree. The ANSM website has a list herethe details of which are also reimbursed by the Health Insurance.
Not all biosimilar drugs are reimbursed at the same level, or even at all, by National Health Insurance.
Some biosimilars are strictly for hospital use, such as Avastin (and its biosimilars), which are used for lung cancer.
To prescribe biosimilars outside the hospital, physicians (and now pharmacists) must meet certain criteria. For example, drugs must be on the Health Insurance list of acceptable substitutes.
The list of biosimilar medicines available to replace the reference medicine is limited and clearly presented. For example, they may offer biosimilar equivalents to the drugs Neupogen and Neulasta.
Neupogen is prescribed for the treatment of persistent neutropenia (a lack of white blood cells) in patients with advanced HIV infection.
Neulasta relieves neutropenia in cancer patients.
These two reference biomedicines can be replaced respectively by four and six specific biosimilar medicines reimbursed by National Health Insurance: Accofil, Nivestim, Tevagrastim and Zarzio for Neupogen; and Cegfila, Fulphila, Nyvepria, Pelgraz, Pelmeg and Ziextenzo for Neulasta.
Taking into account non-reimbursed biosimilar drugs and those whose use is only authorized in hospitals, only about ten drugs are authorized to be replaced by biosimilars in pharmacies.
Some also require a prescription from a hospital, rather than a GP, for treatment to begin, while others can only be prescribed by a specialist (such as Gonal-f, which is used to treat infertility).
Why is it now allowed?
Biosimilar drugs can save the state significant amounts of money, as they can be up to 30% cheaper than their leading brand name counterparts.
A July 2021 report from the National Health Insurance Fund (CNAM) pointed out that spending on rheumatoid arthritis (-46%) and ankylosing spondylitis (-56%) had fallen steadily since 2015.
This is due to the arrival, over the past seven years, of several biosimilar drugs to Remicade, which is the main reference drug prescribed to patients with these diseases.
It comes after pharmacists were given permission last July (2021) to renew and adjust repeat prescriptions without requiring patients to see the doctor again.
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