generics resist, biosimilars wait

generics resist, biosimilars wait
generics resist, biosimilars wait

Recurring observation, “year after year, the penetration rate of generic drugs in cities never exceeds 86%, observes David Syr, executive director at Cegedim Pharma and deputy general director of Gers Data. The challenge now is to find the missing 14% to maximize the margin of the pharmacy network”. According to Gers Data, the penetration rate reaches 85.8% in 2024, compared to 83.9% in 2023 and 84.8% in 2022. A slight increase compared to previous years, “very turbulent years due to breakups”recalls the expert. Since 2023, 11 new molecules have entered the public domain, generating an additional 458 million euros on the generic market. If “the penetration rate of newly generic molecules is variableDavid Syr points out, this year, a record 60% reached, from the first month, by rivaroxaban”. According to AdéquA statistics, generics still occupied first place among drugs contributing to the overall gross margin of pharmacies in 2023, generating 29.52% of it. “Additional margins from discounts, rebates and commercial cooperation are obtained mainly through discounts on generics and weigh very significantly on the pharmacy's finances, which makes it very generic-dependent,” admits the KPMG firm. . His colleague CGP & expertise notes, in this respect, “a similar level of commercial conditions on generics, in 2023, whatever the size of the pharmacy, thanks to the help of groups, but also a drop in discounts granted by generic manufacturers, the missing items essentially harming the level of discounts paid by the main generic manufacturer.

Biosimilars: a patient-dependent transition

All biosimilars combined, the penetration rate peaks at 34.1% in 2024, despite a slight continuous increase over the past two years (32.3% in 2023, 29.2% in 2022). As a reminder, three groups of biosimilars are currently interchangeable in pharmacies. Those of filgastrim and pegfilgrastim – substitutable since April 2022 – will hold, in 2024, respectively 97.7% and 89.3% of market shares compared to bioreferents, according to the Iqvia-Pharmastat network. In fact, however, the substitution effort for these two products comes, to a very large extent, from prescribers. Lucentis – whose market represents 246 million euros in turnover over 12 months – was added to the list of substitutable drugs in November. Still according to Iqvia data, biosimilars from the ranibizumab group currently hold 5% of the market share. “The transition to the biosimilar now relies on good support for the patient to ensure continuity of compliance, believes David Syr. Ranibizumab substitution is a first test. “As the presentation of the product is not the same, the gesture differs, as does the comfort of injection, and this problem concerns most biosimilars”, adds the expert. The challenge of substitution with biosimilars is to access Social Security savings while optimizing patients' quality of life.

The weight of uncertainty

Supporting the patient, yes, but with what remuneration? The question still remains unanswered. Certainly, article 54 of the Social Security Financing Bill (PLFSS) for 2025 authorizes the pharmacist to “substitute a reference biological medicine prescribed by a doctor with its biosimilar two years after the marketing of the first biosimilar of the same group , unless otherwise advised by the National Agency for the Safety of Medicines and Health Products (ANSM).” By December 31, the ANSM should publish its opinion on the opening of new biosimilar groups to substitution, and the implementing orders should follow, at the beginning of 2025. Certainly, during the generalization of generic substitution in pharmacies , “we had observed a massive acceleration in penetration rates and the same phenomenon should occur for biosimilars from 2025”declared, last October, in the columns of Pharmacy monitor, Sébastien Trinquard, general director of the union of generics and biosimilar manufacturers (Gemme). The only problem is that nothing has yet been decided regarding pharmacist remuneration. Gold, “lack of time and low pay are the first two factors for non-engagement in new missions mentioned by pharmacists”points out Bertrand Cadillon, accountant in charge of the pharmacy market at Fiducial. Two variables which could well slow down the development of the market.

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