Search results for " Europe"
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Julie emphasized that 74% of the plasma product related sales comes from Europe and North America but stressed all the unmet needs in the emerging countries. The industry needs to be prepared to also …
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Biosimilars Development and Supply: How Complex Can the Process Be?
A recent report (3) from the European Commission looking at Europe’s strong regulatory and commercial foundation for biosimilars found that biosimilars are improving competition in Europe and increasi…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Early biotechnology products in the US and Europe were characterized by low titers and low cell densities using various cell hosts (1, 2). Most companies had few recombinant products licensed or in de…
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Science Focus Fuels Successful Process Development for Startups
Celyad, a company developing chimeric antigen receptor (CAR)-T cell therapies, built on its previous work with a stem-cell therapy that it took from preclinical development to two Phase II trials in E…
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Drug Quality Key to Innovation and Access
…tion drug shipments, they will face multiple tracking and serialization systems under development in Europe, Asia, and South America. The lack of harmonization in these efforts reflects continued cha…
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Innovation vs. Capacity: How CMOs Compete
…ance (QA) capabilities that support dependable registration and approval of new drugs at FDA and the European Medicines Agency (EMA)
• Capabilities to support clients on a global scale, especiall…
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Aseptic Processing: Keeping it Safe
…ated processes “of the same standard as for products authorized for marketing,” according to the European Commission’s EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and V…
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Setting Standards for Biotech Therapeutics in India
Similar relationships need to be pursued with other global agencies such as National Institute of Biological Standards and Control (NIBSC), and European Directorate for the Quality of Medicines (EDQM)…
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FDA Urged to Preserve Biosimilar Naming Conventions
The practice is already established in Europe and other markets.
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
"But while in Europe more than a dozen products are now commercialized, in the US no company has yet filed for approval of a biosimilar drug since the existence of the FDA's new pathway for biosimilar…