In the battle between biosimilars and biomedicines, the Ministry of Health seeks a consensus

It is a hushed war that has agitated the pharmaceutical industry for more than a decade. Fifteen years after their arrival in France, biosimilars – these almost identical copies of biological drugs whose patent has fallen into the public domain – continue to be the subject of a tense showdown between Big Pharma and the laboratories that market these “almost” generics.

Anxious to preserve the comfortable market shares of their biomedicines, the former are trying to curb any government measure likely to threaten their precinct, while the latter are actively campaigning to accelerate the use of biosimilars.

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At the heart of the battle, the Ministry of Health, which took up the subject, is seeking a consensus. He should make his arbitrations in the coming weeks. Objective: to include future measures in the Social Security financing bill (PLFSS), which will be voted in the autumn by Parliament

With selling prices in the order of 20% to 40% cheaper than the reference biological drugs, biosimilars represent a source of significant potential savings for the State. In 2017, the Court of Auditors calculated that a substitution of 80% of the eight biomedicines – having lost, or on the point of losing their patent, at the time – by biosimilars would allow Medicare to save 680 million euros per year.

Booming market

A tidy estimate, which should increase further in the years to come, with many patents for biological drugs due to expire by 2030. Especially since the market for these drugs, whose molecules are produced from organisms living – unlike “classic” drugs, obtained by chemical synthesis – is booming.

“These are the products of tomorrow. They are used for the treatment of certain cancers, inflammatory or chronic diseases such as rheumatoid arthritis and diabetes, or even orphan diseases. The majority of therapeutic innovations marketed in recent years are biological drugs ”, observes Catherine Bourrienne-Bautista, general delegate of Gemme, the lobby of manufacturers of generics and biosimilars, who insists on the interest of a wider offer to guarantee the security of supplies in the event of a shortage of a drug.

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Economic arguments that do not leave the executive indifferent, while the crisis linked to Covid-19 has widened the Social Security deficit in 2020.

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