Biosimilar Development
 
Featured Editorial
EPIRUS Biopharmaceuticals: What Biosimilars Can Learn From The Generics Market
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
Though differentiating large molecule biosimilars from small molecule generics is a staple in biosimilar education, Amit Munshi, CEO of pure-play biosimilar company EPIRUS Biopharmaceuticals, argues the history of the generics market could hold valuable clues as to how the biosimilar market will evolve.
Regulatory Concerns For Facilities Of The Future: Does Flexibility Come With A Cost?
By Eric Langer, President and Managing Partner, BioPlan Associates   By Eric Langer, President and Managing Partner, BioPlan Associates
Trends in biomanufacturing follow a slow cycle, partly due to the regulated nature of the industry and the substantial costs and risks that introducing a change in the process can bring. But that ignores the benefits that changes in bioprocessing over the past 10 years have brought, from better expression systems to new modular and flexible facilities, sensors, and control systems for downstream operations
How Califf As FDA Commissioner Could Benefit Biosimilar Market
By Anna Rose Welch, Editor, Biosimilar Development   By Anna Rose Welch, Editor, Biosimilar Development
There are still many key decisions that the FDA needs to make when it comes to biosimilars. Why should we feel optimistic that Califf is the man to make them?
News Headlines
Sandoz Receives Positive CHMP Opinion For S.C. Route Of Administration In Biosimilar Binocrit's Nephrology Indication
Formycon Discloses Details On Second Pipeline Product: FYB203 Is A Biosimilar For Eylea (Aflibercept)
Fitch: Biologic Patent “Slope” Supports Innovative Drug Manufacturers
Biosimilars Blog
 
  Read this week’s blog posts on:
• CVS: Doctors Increasingly Prescribing New Brand Diabetes Meds
• Biosimilar Switching Studies On The Rise
• Value-Based Payment: Threat To Biosimilars?

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