News/Headlines
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Webinar: Perspectives on the Future of Pegfilgrastim Biosimilars
Cinfa Biotech is organizing a webinar on October, 11th, titled “Perspectives on the Future...
Guidelines
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FDA issues draft guidance on statistical approaches to evaluating similarity for biosimilars
US FDA has issued an another guidance on statistical approaches to evaluating similarity for biosimilars...
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EMA published a new guideline on biosimilar medicines for healthcare professionals
The European Medicines Agency (EMA) and the European Commission have published an information guide...
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FDA publishes draft guidance for interchangeability
U.S. FDA has released a draft guidance for industry outlining criteria for demonstrating that...
- FDA releases final guidance on biosimilar naming
- FDA announced the Guidance: ‘Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product’
- Tailored scientific advice to support step-by-step development of new biosimilars in EU
Policies
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EMA published a new guideline on biosimilar medicines for healthcare professionals
The European Medicines Agency (EMA) and the European Commission have published an information guide...
Research/Analysis
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Revising CMS policy on biosimilars could save $11.4 billion over 10 years, says AAM’s Biosimilars Council
The Association for Accessible Medicines (AAM) and its Biosimilars Council released an analysis...
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NOR-SWITCH study: Real world evidence on physician-led switching to biosimilars
The NOR-SWITCH results were presented yesterday at the United Gastro-Enterology week in Vienna,...
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Delivering on the Potential of Biosimilar Medicines
IMS Institute recently issued a white paper evaluating the future and potential of biosimilars...
- Ipsos Healthcare launches biosimilar impact study
- WHO issues draft proposal for biosimilar naming
- 2 patents down, 1 to expire: Herceptin biosimilar coming to EU
Latest Posts on Biosimilar News
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Featured News/Headlines
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Featured News/Headlines
Amgen and Simcere announced collaboration to develop and commercialize biosimilars in China
Amgen and Simcere Pharmaceutical Group announced the execution of an exclusive agreement to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.
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Featured Guidelines News/Headlines
FDA issues draft guidance on statistical approaches to evaluating similarity for biosimilars
US FDA has issued an another guidance on statistical approaches to evaluating similarity for biosimilars this week.
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