Tag Archives: biosimilars

Pharma Manufacturing Investments Reflect Key Industry Trends

Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments. Pharmaceutical Technology’s Cynthia Challener offers summary of selected investments in both small- and large-molecule manufacturing facilities during the last year. Numerous trends in the pharmaceutical industry, and particularly in the biopharmaceutical sector, are leading to the need for smaller-capacity production facilities, which in […]
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Biosimilar Development in Europe: Ten Years On

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, […]
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Sandoz Wins Biosimilar Filing Race

 After months of speculation about prospects for biosimilar development in the U.S., Novartis announced July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the […]
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Increase of Biosimilars Will Have “Negative Impact”

A new report from GlobalData states that the increase of biosimilars will have a negative impact on the biologics market after 2019. The report cites patent expirations of branded biologics and regulatory clarification as reasons for the prediction that biosimilars will capture the market share after 2019.
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Eight Ingredients for a Successful Oncology Drug Development Recipe

by Matthew Cook and Sebastien Morisot In light of the risks and challenges inherent in the development of oncologics, some biopharma companies are beginning to question whether oncology remains an attractive therapeutic area in which to invest limited research, development, and commercialization resources.
Posted in Agency Insight, Biotech, Europe, FDA, Gene therapy, Guest Blog, leadership, Market Access, Orphan Drugs, pricing, R&D, Regulatory, Sales | Also tagged , | Leave a comment
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