This is a simple way to make significant savings. At a time when hospitals need resources and when health spending exploded with Covid-19bet on biosimilars is an interesting track. But these complex and recent drugs remain unknown to the general public. And can arouse the mistrust of patients. 20 minutes answers five questions to better understand the issues surrounding these drugs.
What is a biosimilar?
It’s a life-derived medicine (protein, human or animal cell), hence the term “organic” (not to be confused with organic food!), and not chemicals like most of the tablets we swallow. It is called “similar” because it is clinically equivalent to a biologic drug whose patent has fallen into the public domain, but not identical. The principle is therefore similar to generics compared to chemical drugs: a biomedicine (princeps) can be replaced at any time. treatment with its biosimilarwhich will have the same efficacy and the same adverse effects.
“We can never have a perfect equivalence with a drug derived from living organisms, nuance Corinne Blachier-Poisson, president ofAmgen France, a company specializing in medical biotechnology. When we redo a cake with the same recipe, we never have exactly the same result” “We are not on copies, but the minimal variabilities have no impact in terms of efficacy and tolerance” , reassures Jean-Christophe Réglier, medical director of Amgen France. Each biosimilar is unique. »
Today in France, 16 biosimilars are prescribed, including 9 mainly in town. They concern diseases such as diabetes, cancers, autoimmune diseases (multiple sclerosis, rheumatoid arthritis, Crohn’s disease, ulcerative colitis, etc.).
What are the benefits of biosimilars?
Obvious advantage: promoting these biosimilars saves money. Indeed, the development of a biosimilar costs between 100 and 200 million dollars, while that of a biomedicine can reach 2 billion dollars. Its downstream price is therefore lower. “If it is complicated to have a precise figure, the savings would be around 6 billion euros per year in Europe”, advances François Bocquet, pharmacist economist at the Institute of Cancerology of the West. “We are for health savings, for the sustainability of our healthcare system, for innovation and better patient follow-up, assures Alain Olympie, director of the Francois Aupetit Association (AFA) Crohn’s ulcerative colitis (UCH). The success of biosimilars is somewhat everyone’s responsibility”.
There is a second bonus that is less thought of. Having a wider range of treatments available helps to limit supply tensions and prevent stockouts. However, we know that in the face of cancer, access for patients who are highly dependent on treatment is a real problem.
And the obstacles to its development?
Important clarification: it is always the patient who accepts (or refuses!) the modification of his treatment. However, it is not obvious, for a patient suffering from a chronic pathology or cancer, to modify an already restrictive treatment. And this for many reasons.
As you understood above, explaining what a biosimilar is is not easy. It therefore takes time to ensure that the patient has understood the issues and his interest. “Biomedicines have revolutionized patients’ lives, that’s a given,” explains Alain Olympie. But to “switch” to a biosimilar, you have to convince. This is a moment that should not be overlooked because the whole sequence is at stake: the patient’s adherence, his compliance… When your disease has stabilized, you have been taking treatment for several years and you suggest modifying it with an economic argument, I’m not sure that argument works. Hence a collective educational work to be carried out with the general public, and listening in the intimacy of the practice between the doctor and his patient.
Second complication: these are complex treatments, no biosimilar is taken orally. It is therefore often necessary to go through an injection, sometimes in the hospital, sometimes in town. “The presentation of the biosimilar may vary from the originator. It will be necessary for example, with an insulin pen, to wait two clicks and instead of one, which can be a source of error, ”specifies the medical director of Amgen France. “There may be a ‘nocebo effect’ or the injection may be more painful,” warns Alain Olympie.
Are biosimilars developing in France?
Not fast enough, judge Amgen (who has every interest in the pace being even more sustained). But the figures are clear: 15% of biomedicines sold in 2019 were biosimilars, compared to 34% in 2021. “Development has been rapid in hospitals, less in the city and more heterogeneously depending on the molecules”, specifies François Bocquet. . According to a March 2022 report of the GÉnérique Same MEdicament association (Gemme), their penetration rate exceeds 70% in hospitals but only reaches 25% in the city, far from the 80% objective defined within the framework of the National Health Strategy 2018-2022 by Agnès Buzyn.
However, two novelties should change the game. Since January 2022, liberals receive financial incentive to prescribe these biosimilars. “It caused debate, recognizes the pharmacist. But the financial incentive already exists for generics. And that seems to be bearing fruit: we would have gone from 34% of sales in 2021 to 40% in 2022.
Second acceleration factor: since April 2022, pharmacists can offer the substitution directly in pharmacies. But the experiment only targets a single biosimilar drug (rather than two as planned)… which, moreover, is already very often prescribed instead of the biodrug. “We are asking that this substitution in pharmacies be carried out on the basis of clear criteria and with rigorous monitoring in terms of benefits”, notes the president of Amgen. What grieves Alain Olympie and his patient association more is the lack of training for pharmacists. However, as we have seen, pedagogy is essential. “The key word is trust”.