Netherlands-based biopharmaceutical company Synthon announced on 18 July 2012 that it has entered into a global licensing agreement with Amgen and Watson Pharmaceuticals for the clinical development and testing of biosimilar trastuzumab as an alternative to Roche’s blockbuster anticancer agent Herceptin. The deal follows the results of a phase I trial reported on 22 March 2012 showing bioequivalence between Synthon’s trastuzumab and Herceptin [1].
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Genéricos
Novedades
- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
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Investigación
- Japan’s drug shortage crisis: challenges and policy solutions
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General
- Crecimiento de medicamentos genéricos en Brasil y Venezuela
- EMA launches European shortages monitoring platform to tackle persistent medicine shortages
- Penetración de los medicamentos genéricos en México y Brasil
- FDA releases one-year progress report for the Generic Drug Cluster
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Biosimilares
Novedades
- EMA recommends approval for three biosimilars: Jubereq, Osvyrti, and Qoyvolma
- FDA biosimilar approvals in March 2025: Bomyntra, Conexxence, and Omlyclo
- Canada approves pegfilgrastim biosimilar Pexegra
- Insulin aspart and denosumab biosimilars approved in US
Investigación
- How the WHO is expanding access to biosimilars
- Optimización de costes con biosimilares: El caso de Brasil
- Biosimilares en países de ingresos bajos y medios
- Resultados positivos del criterio principal de seguridad y eficacia de AVT05 (biosimilar propuesto de golimumab)
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