{
"@context": "https://schema.org",
"@graph": [
{
"@type": "MedicalWebPage",
"name": "Produits pharmaceutiques biosimilaires : Questions médicales les plus fréquentes",
"headline": "Produits pharmaceutiques biosimilaires : Comprendre les symptômes, diagnostics et traitements",
"description": "Guide complet et accessible sur les Produits pharmaceutiques biosimilaires : explications, diagnostics, traitements et prévention. Information médicale validée destinée aux patients.",
"datePublished": "2024-05-23",
"dateModified": "2025-11-14",
"inLanguage": "fr",
"medicalAudience": [
{
"@type": "MedicalAudience",
"name": "Grand public",
"audienceType": "Patient",
"healthCondition": {
"@type": "MedicalCondition",
"name": "Produits pharmaceutiques biosimilaires"
},
"suggestedMinAge": 18,
"suggestedGender": "unisex"
},
{
"@type": "MedicalAudience",
"name": "Médecins",
"audienceType": "Physician",
"geographicArea": {
"@type": "AdministrativeArea",
"name": "France"
}
},
{
"@type": "MedicalAudience",
"name": "Chercheurs",
"audienceType": "Researcher",
"geographicArea": {
"@type": "AdministrativeArea",
"name": "International"
}
}
],
"reviewedBy": {
"@type": "Person",
"name": "Dr Olivier Menir",
"jobTitle": "Expert en Médecine",
"description": "Expert en Médecine, Optimisation des Parcours de Soins et Révision Médicale",
"url": "/static/pages/docteur-olivier-menir.html",
"alumniOf": {
"@type": "EducationalOrganization",
"name": "Université Paris Descartes"
}
},
"isPartOf": {
"@type": "MedicalWebPage",
"name": "Produits biologiques",
"url": "https://questionsmedicales.fr/mesh/D001688",
"about": {
"@type": "MedicalCondition",
"name": "Produits biologiques",
"code": {
"@type": "MedicalCode",
"code": "D001688",
"codingSystem": "MeSH"
},
"identifier": {
"@type": "PropertyValue",
"propertyID": "MeSH Tree",
"value": "D20.215"
}
}
},
"about": {
"@type": "MedicalCondition",
"name": "Produits pharmaceutiques biosimilaires",
"alternateName": "Biosimilar Pharmaceuticals",
"code": {
"@type": "MedicalCode",
"code": "D059451",
"codingSystem": "MeSH"
}
},
"author": [
{
"@type": "Person",
"name": "Arnold G Vulto",
"url": "https://questionsmedicales.fr/author/Arnold%20G%20Vulto",
"affiliation": {
"@type": "Organization",
"name": "Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands."
}
},
{
"@type": "Person",
"name": "Liese Barbier",
"url": "https://questionsmedicales.fr/author/Liese%20Barbier",
"affiliation": {
"@type": "Organization",
"name": "Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium. liese.barbier@kuleuven.be."
}
},
{
"@type": "Person",
"name": "Steven Simoens",
"url": "https://questionsmedicales.fr/author/Steven%20Simoens",
"affiliation": {
"@type": "Organization",
"name": "Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium."
}
},
{
"@type": "Person",
"name": "Isabelle Huys",
"url": "https://questionsmedicales.fr/author/Isabelle%20Huys",
"affiliation": {
"@type": "Organization",
"name": "Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium."
}
},
{
"@type": "Person",
"name": "Aaron S Kesselheim",
"url": "https://questionsmedicales.fr/author/Aaron%20S%20Kesselheim",
"affiliation": {
"@type": "Organization",
"name": "Aaron S. Kesselheim is a professor of medicine and the director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School."
}
}
],
"citation": [
{
"@type": "ScholarlyArticle",
"name": "TNFα inhibitor biosimilar associated with polychondritis. A case-based review.",
"datePublished": "2023-06-15",
"url": "https://questionsmedicales.fr/article/37316633",
"identifier": {
"@type": "PropertyValue",
"propertyID": "DOI",
"value": "10.1007/s00296-023-05364-9"
}
},
{
"@type": "ScholarlyArticle",
"name": "Investigation of Immunogenicity Assessment of Biosimilar Monoclonal Antibodies in the United States.",
"datePublished": "2023-09-11",
"url": "https://questionsmedicales.fr/article/37634125",
"identifier": {
"@type": "PropertyValue",
"propertyID": "DOI",
"value": "10.1002/cpt.3033"
}
},
{
"@type": "ScholarlyArticle",
"name": "Assessment of structural and functional similarity of biosimilar products: Bevacizumab as a case study.",
"datePublished": "2023-09-25",
"url": "https://questionsmedicales.fr/article/37776677",
"identifier": {
"@type": "PropertyValue",
"propertyID": "DOI",
"value": "10.1016/j.jchromb.2023.123896"
}
},
{
"@type": "ScholarlyArticle",
"name": "Multi-attribute method (MAM) to assess analytical comparability of adalimumab biosimilars.",
"datePublished": "2023-06-22",
"url": "https://questionsmedicales.fr/article/37385093",
"identifier": {
"@type": "PropertyValue",
"propertyID": "DOI",
"value": "10.1016/j.jpba.2023.115543"
}
},
{
"@type": "ScholarlyArticle",
"name": "Rituximab reference vs biosimilar utilization for oncology vs nononcology indications.",
"datePublished": "2023-11-01",
"url": "https://questionsmedicales.fr/article/37948656",
"identifier": {
"@type": "PropertyValue",
"propertyID": "DOI",
"value": "10.37765/ajmc.2023.89461"
}
}
],
"breadcrumb": {
"@type": "BreadcrumbList",
"itemListElement": [
{
"@type": "ListItem",
"position": 1,
"name": "questionsmedicales.fr",
"item": "https://questionsmedicales.fr"
},
{
"@type": "ListItem",
"position": 2,
"name": "Mélanges complexes",
"item": "https://questionsmedicales.fr/mesh/D045424"
},
{
"@type": "ListItem",
"position": 3,
"name": "Produits biologiques",
"item": "https://questionsmedicales.fr/mesh/D001688"
},
{
"@type": "ListItem",
"position": 4,
"name": "Produits pharmaceutiques biosimilaires",
"item": "https://questionsmedicales.fr/mesh/D059451"
}
]
}
},
{
"@type": "MedicalWebPage",
"name": "Article complet : Produits pharmaceutiques biosimilaires - Questions et réponses",
"headline": "Questions et réponses médicales fréquentes sur Produits pharmaceutiques biosimilaires",
"description": "Une compilation de questions et réponses structurées, validées par des experts médicaux.",
"datePublished": "2026-02-06",
"inLanguage": "fr",
"hasPart": [
{
"@type": "MedicalWebPage",
"name": "Diagnostic",
"headline": "Diagnostic sur Produits pharmaceutiques biosimilaires",
"description": "Comment évaluer l'efficacité d'un biosimilaire ?\nQuels tests sont utilisés pour les biosimilaires ?\nComment confirmer la sécurité d'un biosimilaire ?\nQuels critères pour un biosimilaire ?\nComment distinguer un biosimilaire d'un générique ?",
"url": "https://questionsmedicales.fr/mesh/D059451?page=3#section-diagnostic"
},
{
"@type": "MedicalWebPage",
"name": "Symptômes",
"headline": "Symptômes sur Produits pharmaceutiques biosimilaires",
"description": "Quels effets secondaires des biosimilaires ?\nLes biosimilaires causent-ils des symptômes spécifiques ?\nComment gérer les effets indésirables ?\nLes biosimilaires provoquent-ils des allergies ?\nQuels symptômes d'une réaction allergique ?",
"url": "https://questionsmedicales.fr/mesh/D059451?page=3#section-symptômes"
},
{
"@type": "MedicalWebPage",
"name": "Prévention",
"headline": "Prévention sur Produits pharmaceutiques biosimilaires",
"description": "Comment prévenir les effets indésirables des biosimilaires ?\nDes précautions avant d'utiliser un biosimilaire ?\nComment informer les patients sur les biosimilaires ?\nLes biosimilaires nécessitent-ils un suivi régulier ?\nQuelles sont les recommandations pour les biosimilaires ?",
"url": "https://questionsmedicales.fr/mesh/D059451?page=3#section-prévention"
},
{
"@type": "MedicalWebPage",
"name": "Traitements",
"headline": "Traitements sur Produits pharmaceutiques biosimilaires",
"description": "Comment sont administrés les biosimilaires ?\nPeut-on remplacer un médicament par un biosimilaire ?\nLes biosimilaires nécessitent-ils une surveillance ?\nQuels traitements utilisent des biosimilaires ?\nLes biosimilaires sont-ils moins chers ?",
"url": "https://questionsmedicales.fr/mesh/D059451?page=3#section-traitements"
},
{
"@type": "MedicalWebPage",
"name": "Complications",
"headline": "Complications sur Produits pharmaceutiques biosimilaires",
"description": "Quelles complications peuvent survenir avec les biosimilaires ?\nComment gérer une réaction allergique grave ?\nLes biosimilaires augmentent-ils le risque d'infections ?\nQuelles sont les complications à long terme ?\nComment surveiller les complications des biosimilaires ?",
"url": "https://questionsmedicales.fr/mesh/D059451?page=3#section-complications"
},
{
"@type": "MedicalWebPage",
"name": "Facteurs de risque",
"headline": "Facteurs de risque sur Produits pharmaceutiques biosimilaires",
"description": "Quels facteurs augmentent le risque d'effets indésirables ?\nLes patients âgés sont-ils plus à risque ?\nComment les comorbidités influencent-elles le traitement ?\nLes antécédents d'allergies sont-ils un facteur de risque ?\nLe mode de vie influence-t-il l'efficacité des biosimilaires ?",
"url": "https://questionsmedicales.fr/mesh/D059451?page=3#section-facteurs de risque"
}
]
},
{
"@type": "FAQPage",
"mainEntity": [
{
"@type": "Question",
"name": "Comment évaluer l'efficacité d'un biosimilaire ?",
"position": 1,
"acceptedAnswer": {
"@type": "Answer",
"text": "L'efficacité est évaluée par des études cliniques comparatives avec le produit de référence."
}
},
{
"@type": "Question",
"name": "Quels tests sont utilisés pour les biosimilaires ?",
"position": 2,
"acceptedAnswer": {
"@type": "Answer",
"text": "Des tests de bioéquivalence et des études pharmacocinétiques sont réalisés."
}
},
{
"@type": "Question",
"name": "Comment confirmer la sécurité d'un biosimilaire ?",
"position": 3,
"acceptedAnswer": {
"@type": "Answer",
"text": "La sécurité est confirmée par des essais cliniques et un suivi post-commercialisation."
}
},
{
"@type": "Question",
"name": "Quels critères pour un biosimilaire ?",
"position": 4,
"acceptedAnswer": {
"@type": "Answer",
"text": "Un biosimilaire doit démontrer une similarité en qualité, sécurité et efficacité."
}
},
{
"@type": "Question",
"name": "Comment distinguer un biosimilaire d'un générique ?",
"position": 5,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les biosimilaires sont des copies de médicaments biologiques, tandis que les génériques sont des copies de médicaments chimiques."
}
},
{
"@type": "Question",
"name": "Quels effets secondaires des biosimilaires ?",
"position": 6,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les effets secondaires peuvent inclure des réactions allergiques, des infections et des douleurs au site d'injection."
}
},
{
"@type": "Question",
"name": "Les biosimilaires causent-ils des symptômes spécifiques ?",
"position": 7,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les symptômes dépendent du traitement, mais peuvent inclure fatigue, nausées ou fièvre."
}
},
{
"@type": "Question",
"name": "Comment gérer les effets indésirables ?",
"position": 8,
"acceptedAnswer": {
"@type": "Answer",
"text": "La gestion inclut l'ajustement de la dose, le changement de médicament ou le traitement des symptômes."
}
},
{
"@type": "Question",
"name": "Les biosimilaires provoquent-ils des allergies ?",
"position": 9,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, des réactions allergiques peuvent survenir, nécessitant une surveillance attentive."
}
},
{
"@type": "Question",
"name": "Quels symptômes d'une réaction allergique ?",
"position": 10,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les symptômes incluent éruption cutanée, démangeaisons, gonflement et difficultés respiratoires."
}
},
{
"@type": "Question",
"name": "Comment prévenir les effets indésirables des biosimilaires ?",
"position": 11,
"acceptedAnswer": {
"@type": "Answer",
"text": "La prévention inclut une évaluation préalable, une surveillance et une éducation des patients."
}
},
{
"@type": "Question",
"name": "Des précautions avant d'utiliser un biosimilaire ?",
"position": 12,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, il est important d'évaluer les antécédents médicaux et les allergies du patient."
}
},
{
"@type": "Question",
"name": "Comment informer les patients sur les biosimilaires ?",
"position": 13,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les patients doivent être informés des bénéfices, risques et différences avec le produit de référence."
}
},
{
"@type": "Question",
"name": "Les biosimilaires nécessitent-ils un suivi régulier ?",
"position": 14,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, un suivi régulier est essentiel pour évaluer l'efficacité et la sécurité du traitement."
}
},
{
"@type": "Question",
"name": "Quelles sont les recommandations pour les biosimilaires ?",
"position": 15,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les recommandations incluent une utilisation appropriée, une surveillance et une évaluation continue."
}
},
{
"@type": "Question",
"name": "Comment sont administrés les biosimilaires ?",
"position": 16,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les biosimilaires sont généralement administrés par injection sous-cutanée ou intraveineuse."
}
},
{
"@type": "Question",
"name": "Peut-on remplacer un médicament par un biosimilaire ?",
"position": 17,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, un biosimilaire peut remplacer un médicament de référence après évaluation par un médecin."
}
},
{
"@type": "Question",
"name": "Les biosimilaires nécessitent-ils une surveillance ?",
"position": 18,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, une surveillance est nécessaire pour détecter les effets indésirables et évaluer l'efficacité."
}
},
{
"@type": "Question",
"name": "Quels traitements utilisent des biosimilaires ?",
"position": 19,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les biosimilaires sont utilisés dans le traitement de maladies comme l'arthrite, le cancer et la sclérose en plaques."
}
},
{
"@type": "Question",
"name": "Les biosimilaires sont-ils moins chers ?",
"position": 20,
"acceptedAnswer": {
"@type": "Answer",
"text": "En général, les biosimilaires sont moins chers que les médicaments de référence, mais le coût varie."
}
},
{
"@type": "Question",
"name": "Quelles complications peuvent survenir avec les biosimilaires ?",
"position": 21,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les complications peuvent inclure des infections, des réactions allergiques et des effets indésirables graves."
}
},
{
"@type": "Question",
"name": "Comment gérer une réaction allergique grave ?",
"position": 22,
"acceptedAnswer": {
"@type": "Answer",
"text": "En cas de réaction grave, il faut arrêter le traitement et administrer des antihistaminiques ou des corticostéroïdes."
}
},
{
"@type": "Question",
"name": "Les biosimilaires augmentent-ils le risque d'infections ?",
"position": 23,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, les biosimilaires peuvent augmenter le risque d'infections en raison de l'immunosuppression."
}
},
{
"@type": "Question",
"name": "Quelles sont les complications à long terme ?",
"position": 24,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les complications à long terme peuvent inclure des effets indésirables persistants et des problèmes immunitaires."
}
},
{
"@type": "Question",
"name": "Comment surveiller les complications des biosimilaires ?",
"position": 25,
"acceptedAnswer": {
"@type": "Answer",
"text": "La surveillance inclut des examens réguliers, des analyses de sang et des évaluations cliniques."
}
},
{
"@type": "Question",
"name": "Quels facteurs augmentent le risque d'effets indésirables ?",
"position": 26,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les facteurs incluent des antécédents d'allergies, des comorbidités et des traitements concomitants."
}
},
{
"@type": "Question",
"name": "Les patients âgés sont-ils plus à risque ?",
"position": 27,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, les patients âgés peuvent avoir un risque accru d'effets indésirables et de complications."
}
},
{
"@type": "Question",
"name": "Comment les comorbidités influencent-elles le traitement ?",
"position": 28,
"acceptedAnswer": {
"@type": "Answer",
"text": "Les comorbidités peuvent affecter la tolérance et l'efficacité des biosimilaires, nécessitant des ajustements."
}
},
{
"@type": "Question",
"name": "Les antécédents d'allergies sont-ils un facteur de risque ?",
"position": 29,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, des antécédents d'allergies augmentent le risque de réactions indésirables aux biosimilaires."
}
},
{
"@type": "Question",
"name": "Le mode de vie influence-t-il l'efficacité des biosimilaires ?",
"position": 30,
"acceptedAnswer": {
"@type": "Answer",
"text": "Oui, un mode de vie sain peut améliorer l'efficacité et réduire les risques d'effets indésirables."
}
}
]
}
]
}
Relapsing polychondritis (RP) is a rare autoimmune disease characterized by inflammation of the cartilage structures of the body with typical features of auricular chondritis, nasal and ocular inflamm...
Immunogenicity is critical for biologics. However, reference biologics labeling documents do not necessarily mention immunogenicity impact, rendering the development of biosimilars more challenging. W...
The antiangiogenic drug bevacizumab is a blockbuster therapeutic pharmaceutical product that is used to treat many different types of cancer including kidney, colon, rectum, lung, and breast cancer. A...
Adalimumab drug product (Humira ®), the first fully human monoclonal antibody (mAb) approved by FDA in 2002, led the top ten list of best-selling mAbs in 2018 and has been the most profitable drug in ...
Limited data exist on the adoption of rituximab biosimilars vs the reference product by indication. Available data from real-world studies comparing rituximab biosimilar and reference use have focused...
Comparative analysis....
Deidentified real-world data of rituximab, rituximab-abbs, rituximab-pvvr, and rituximab-arrx dispensations between December 31, 2018, and February 1, 2022, were extracted using Trisus Medication Comp...
A total of 28,025 encounters were captured for rituximab and its biosimilars across 193 facilities (rituximab: n = 23,395; biosimilars, n = 4631 [rituximab-abbs: n = 2550; rituximab-pvvr, n = 2081; ri...
Real-world evidence shows an increase in rituximab biosimilar adoption over time, with higher adoption for oncology vs nononcology indications and in nonacademic settings....
Biosimilars offer increased patient choice and potential cost-savings, compared with originator biologics. We studied 3 years of prescribed biologics among US physician practices to determine the rela...
We acquired biologic utilization data from 38 practices participating in PracticeNET. We focused on six biologics (bevacizumab, epoetin alfa, filgrastim, pegfilgrastim, rituximab, and trastuzumab) for...
Use of biosimilars increased over the 3-year period, reaching between 51% and 80% of administered doses by the fourth quarter of 2021, depending on the biologic. Biosimilar use varied by practice, wit...
Biosimilars have, through increased use, lowered the average cost per dose of the studied biologics. Biosimilar use differed by originator biologic, practice type, and payment source. There remains fu...
Recent literature has found rapid uptake of short-acting filgrastim biosimilars but slower uptake of other biosimilars, such as infliximab, in both Medicare and privately insured enrollees....
To describe patient, provider, and health plan characteristics associated with a switch to biosimilar among existing infliximab patients....
We constructed a retrospective panel dataset of patients undergoing active infliximab treatments and the choice of infliximab drug for each infusion. We used mixed logit regression controlling for pat...
Medicare Advantage and privately insured enrollees with evidence of active infliximab treatments between 2016 and 2020 (n=357,430)....
Our primary outcome of interest was to switch from infliximab originator to one of the infliximab biosimilars. Exposure variables of interest variables such as out-of-pocket, site of care, and in-netw...
Our study found nominally low switching among existing infliximab originator users (3.4%). We found that patients who previously received 1 infliximab originator infusion were 63.7% more likely to swi...
To encourage uptake and switch to biosimilar, policymakers should consider targeted policies that include leveraging health plan tools such as placement of biosimilar as preferred drug and aim to educ...
The Chinese biosimilar industry has demonstrated rapid growth in recent years. Limited evidence is available about biosimilar uptake at the national level. This study aimed to assess biosimilar uptake...
This study employed an interrupted time series analysis to assess the level and trend changes of national trastuzumab originator consumption and the overall trastuzumab consumption after the price red...
After rapid growth, the penetration of biosimilars demonstrated a moderate ascending trend at the national level, reaching 27% in February 2023. Following the introduction of the first biosimilar in J...
The uptake of trastuzumab biosimilars in China was lower compared with major European countries. The introduction of trastuzumab biosimilars presented a substitutional effect. Perceptions of physician...
There is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval of more complex biosimilar substances such as monoclonal antibodies (mAbs)....
The aim of this paper is to further analyse the role of quality/chemistry, manufacturing and controls (CMC) and clinical data for the conclusion on biosimilarity and the decision on marketing authoris...
In the present study, we analysed the MA applications (MAAs) of all 33 mAbs and three fusion proteins evaluated by the European Medicines Agency (EMA) between July 2012 and November 2022 with special ...
In 67% of cases, the outcome of the quality and clinical assessment was the same, i.e. both the quality and clinical assessments either supported approval or did not support approval. In 11% of cases,...
The results further support the argument that sufficient evidence for biosimilarity can be obtained from a combination of analytical and functional testing and pharmacokinetic studies which may also g...
This project aimed to produce a biosimilar version of aflibercept (AFL) and evaluate the effect of the co-treatment of AFL with other vascular endothelial growth factor (VEGF) blocker drugs. For this ...