Médicaments biologiques et biosimilaires : comment aborder l'interchangeabilité ?

Abstract : Biologic drugs are complex molecules produced from a biological source such as bacteria or animal cells in culture. These therapies are expensive and contribute to increase health expenditures. Following the expiry of patent, copies called "biosimilars" can be marketed. In 2017, the global market for biological drugs represented about USD 210 billion, including nearly USD 5.5 billion for the biosimilars market, with a rate of growth of more than 30% expected for biosimilars by 2022. Due to the complexity and the variability of the biological source, the biosimilars are not identical to the reference drug. Any differences are strictly defined within limits to ensure patients quality, efficiency and safety, as for any medication. With the arrival of biosimilars, concerns arise about the interchangeability between the reference drug and its biosimilar(s). The main advantages are: lower costs, increased accessibility of patients to biological molecules and the choice of treatments for health professionals. While most of them do not oppose to prescribe biosimilars when treatment is started, they have more concerns about switching to biosimilar a patient already taking the reference medicine (or another biosimilar), especially because of the risk of immunogenicity. In this context, communication to healthcare professionals and patients plays a key role in ensuring optimal care.
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Master Thesis
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Audrey Denarie. Médicaments biologiques et biosimilaires : comment aborder l'interchangeabilité ?. Sciences pharmaceutiques. 2019. ⟨dumas-02176856⟩

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