An amendment is being debated on whether pharmacies can substitute approved replacements for biological medicines, but patient organisations have raised concerns.
ADVERTISEMENTFrench MPs are debating an amendment to a 2024 health insurance budget law that would allow pharmacists to replace all biological drugs, like insulin or vaccines, with alternatives akin to generics two years after they become available.
The amendment would allow them to make the change unless the French medicines regulator objects to it.
Yet some organisations representing patients have expressed concerns about the proposal.
What are biomedicines and biosimilars?
Biosimilars are replicas of biological drugs, treatments derived not from chemical synthesis but from living organisms, such as insulin, vaccines, monoclonal antibodies, and growth hormones, whose patents have expired.
While sometimes simplistically presented as the biological equivalent of generic drugs, biosimilars, like generics, come with a lower price tag than the reference medicine.
However, unlike generics, biosimilars are not entirely identical to their reference product due to their biological nature, complicating the production processes.
Currently, for biomedicines to be used as substitutes, they must be named on an official list and based on the advice of France's National Agency for the Safety of Medicines and Health Products (ANSM).
In hospitals, substitution programs are well-established, but currently, only two substitutable biological molecules (pegfilgrastim and filgrastim) exist in community pharmacies.
The government aims to expand these efforts, as stated in the amendment to be debated this week in the Senate.
"Given the potential for significant savings for health insurance represented by biosimilar drugs (...), new measures to accelerate the use of these products should be considered," the amendment reads.
The expected savings have not been disclosed.
This proposal aligns with the European Medicines Agency (EMA)'s April 2023 opinion that biosimilars approved in the EU are interchangeable.
'Risk of misuse'
However, a collective of organisations representing patients said on Tuesday they were "unfavourable" towards substituting biomedicines "in community pharmacies for chronic diseases".
They requested to be "included, along with learned societies, alongside the ANSM for any prior and systematic consultation before the substitution decision."
The ANSM is expected to decide on substitutions by the end of 2024.
"The manufacturers need visibility on these substitutable molecules," said Gemme, a lobby representing generic and biosimilar manufacturers, pointing out that the "prices are 40 per cent cheaper than the bioreferences."
Patients' groups, meanwhile, say that despite being aware of the economic argument, they point out that biosimilars, especially for patients with often progressive and debilitating chronic diseases such as Crohn's disease, multiple sclerosis, and rheumatoid arthritis, are all injectable.
They say that the injection device may require one or more clicks, turning or pressing a button and the needle size may also vary.
ADVERTISEMENTGiven "the complex relationship patients have with these drugs," they say that patients may fear that the product is not as effective and there could be a "risk of misuse".
Fréderic Bizard, a professor of economics at ESCP Europe, said patient organisations were wrong and that the drugs are reliable.
"If we do not develop the market for biosimilars and generics sufficiently,” he said, the financing of the health system in France will "not be sustainable".
