Pharmacists in France can now give ‘biosimilar’ medicines to sufferers for some prescriptions after France authorised the follow – however this isn’t the identical as ‘generic’ equivalents. We clarify.
What’s now allowed?
Pharmacists in France at the moment are authorised to present medicines which are thought-about to be ‘biosimilar’ to some particular medicine prescribed, after a decree within the authorities’s legislative publication, the Journal officiel, from April 14.
Biosimilar medicine are successfully the identical medicine (by way of content material and energetic components) as the unique model, however are usually cheaper. There could also be some variations in components however they’re meant for use for the very same remedy because the dearer model.
They don’t seem to be the identical as ‘generic’ medicine, that are non-branded, actual chemical copies of the unique drug. For instance, Doliprane is a paracetamol painkiller model, however generic variations are merely labelled as the primary ingredient, ‘paracetamol’, with no model.
In distinction, biosimilar medicine are copies which are very related, however not at all times an identical, to therapies which are generally known as ‘organic’. They’ve their very own model, and are sometimes prescribed for the remedy of circumstances similar to diabetes, most cancers, infertility, or osteoporosis.
Are there guidelines on which medicine could be thought-about biosimilar?
Sure. For a drug to be thought-about a real substitute, it should have been “authorised in Europe for eight years and its patent should have fallen into the general public area”, says medicine security company l’Agence nationale de sécurité du médicament et des produits de santé (ANSM).
Which medicine at the moment are in a position to get replaced with biosimilar equivalents?
A complete of 16 medicine are included within the new decree. The ANSM web site has an inventory right here, with particulars of that are additionally reimbursed by Assurance maladie.
Not all biosimilar medicine are reimbursed to the identical degree, or in any respect, by Assurance maladie.
Some biosimilar medicine are strictly just for use in a hospital setting, similar to Avastin (and its biosimilar copies), that are used within the case of bronchial most cancers.
To prescribe biosimilar medicine exterior of hospital, docs (and now pharmacists) should respect sure standards. For instance, the medicine have to be featured on the record of acceptable replacements from Assurance maladie.
The record of biosimilar medicines accessible to exchange the reference drug is proscribed and clearly laid out. For instance, they’ll provide biosimilar equivalents to the medicine Neupogen and Neulasta.
Neupogen is prescribed for the remedy of persistent neutropenia (an absence of white blood cells) in sufferers with superior HIV an infection.
Neulasta relieves neutropenia in most cancers sufferers.
These two reference biomedicines could be substituted respectively by 4 and 6 particular biosimilar medicines reimbursed by Assurance maladie: Accofil, Nivestim, Tevagrastim and Zarzio for Neupogen; and Cegfila, Fulphila, Nyvepria, Pelgraz, Pelmeg, and Ziextenzo for Neulasta.
Considering biosimilar medicine that aren’t reimbursed, and people which are solely allowed for use in hospital settings, solely round a dozen medicine are permitted to get replaced by biosimilars in pharmacies.
Some additionally require a prescription from a hospital, reasonably than a GP, to ensure that remedy to start, whereas some could be prescribed by a specialist solely (similar to Gonal-f, which is used to deal with infertility).
Why is that this now allowed?
Biosimilar medicine can save the state important sums of cash, as they are often as much as 30% cheaper than their main branded equivalents.
A July 2021 report from the Caisse nationale d’Assurance maladie (CNAM) highlighted that spending on rheumatoid arthritis (-46%) and ankylosing spondylitis (-56%) had decreased persistently since 2015.
That is as a result of arrival, over the previous seven years, of a number of biosimilar drugs to Remicade, which is the primary reference drug prescribed to sufferers affected by these ailments.
It comes after pharmacists got authorisation, in July final yr (2021), to resume and alter repeat prescriptions with out requiring sufferers to go to the physician once more.
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