National and International Policies on the Use of Biosimilars: An Environmental Scan
Pourquoi ce travail est dans la base
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Notice bibliographique
Résumé
Biosimilars are biologic drugs that are highly similar to their reference biologics that were already authorized for sale. Interchangeability is a term used to describe when 1 drug can be exchanged for another and is expected to have the same clinical effect. Interchangeability may allow 1 medicine to be substituted for another at the time of dispensing (automatic substitution). However, the decision to allow automatic substitution is made by each jurisdiction according to its own regulations. Interchangeability of a reference biologic (the originator product) and a biosimilar is a designation in the US and Finland. The US, France, Germany, Norway, and Australia allow automatic substitution between reference biologics and biosimilars, whereas other countries do not. Interchangeability is limited to select products in the US and Australia. The countries included in this Environmental Scan (N = 13) endorse starting patients who have not yet received treatment on a biosimilar. Switching between reference biologics and biosimilars is generally allowed in all the countries included in this review; however, many jurisdictions prefer switching be clinician led with ongoing clinical monitoring of patients. Practices such as target setting, quotas, and financial incentives, as well as guidelines and recommendations for prescription of biosimilars, can be effective ways to encourage biosimilar use. Mandatory switching is also implemented in 11 Canadian jurisdictions. Extrapolation is the regulatory and scientific process of granting a clinical indication to a medicine without clinical efficacy and safety data to support that indication. Extrapolation of indications for reference biologics to biosimilars is reasonable, provided several factors are comparable: mechanism of action across indications, pharmacokinetics and biodistribution, safety, immunogenicity, and other factors that affect the safety and efficacy for each indication and patient population. Pricing and procurement practices vary internationally. Some countries implement policies controlling the list price of a biosimilar (and its reference drug less commonly) at the time of biosimilar launch. Pricing policies include a free-pricing policy (i.e., manufacturers are free to set the price of biosimilars) and mandatory price reductions. Tendering is the most common practice in procurement to achieve lower prices and to increase biosimilar uptakes in 8 countries reviewed in this Environmental Scan. Biosimilar-related policies and markets are rapidly evolving, so recent changes might have not been fully captured in this Environmental Scan. Therefore, caution is required in interpreting the findings.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle