The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs that treat serious and chronic diseases.
In a new draft guidance, the FDA proposes major updates to simplify biosimilarity studies and reduce unnecessary clinical testing. The agency through a separate initiative also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily.
Expensive biologic medications make up only 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024. FDA-approved biosimilars are as safe and effective as the branded drugs, yet their market share remains below 20%. To date, FDA has approved 76 biosimilars, corresponding to a small fraction of approved biologics. By contrast, there are more than 30,000 approved generics, exceeding the number of approved brand drugs. Only about 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development.
Currently, in some circumstances, developers perform “switching studies” for biosimilars licensed as interchangeable – a step not required for generic drugs. These additional studies can slow development and create public confusion about biosimilar safety. The FDA now generally does not recommend switching studies. As industries and authorities adjust to this change, Echa and industry experts will continue to monitor advances in this area.
Reference:
FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs | FDA
Today we announce that Exim is rebranding as ExSyn. We are presenting a new brand identity and website as a reflection of our relentless transformation over the course of 30 years serving the pharma and chemical industries. The new brand builds upon our core strengths as a sourcing company and captures our most essential duty: helping improve people’s health and lives.
Jackpot City : Plongée Dans l’Univers des Casinos en Ligne Jackpot City Online Casino est une destination incontournable pour les amateurs de jeux de casino. Avec des offres de jeux variées, des promotions attractives et une expérience utilisateur exceptionnelle, ce casino en ligne se distingue par ses fonctionnalités et sa convivialité. Dans cet article, nous […]
Aquí tienes lo útil de entrada: si quieres entender cuándo una apuesta de proposición (prop) es razonable y cuándo una acción de una empresa de juego puede ser inversión (o puro ruido), necesito que sigas tres pasos prácticos: 1) define tu bankroll o capital de inversión y un stop claro; 2) mide la volatilidad del […]
bitstarsmexico.com para comparar cómo exponen protocolos y tiempos de retiro en su sección de ayuda. H2: Tokenización aplicada a productos específicos (bonos, fichas, NFTs) – Bonos y wagering: tokenizar el crédito promocional permite trazabilidad de uso y evita manipulación. Calcula el rollover real: si recibes $100 con WR 40× y tienes saldo convertible a token, […]