Search results for "biosimilar" in Articles / App Notes
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
New developments were seen in the area of biosimilars and biobetters in the United States, the UK, and the Netherlands. Sharing insights into intellectual property (IP) protection challenges on both s…
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Biopharma Advances Demand Specialized Expertise
The approval of the first biosimilar in the United States, as well as continuing consolidation in the biopharma and contract development and manufacturing markets, are just two indicators of the ongoi…
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Biopharma in 2015: A Year for Approvals and Innovations
One of the most groundbreaking approvals occurred in March, when the FDA approved the first biosimilar in the US (years after the first such approval in Europe), Sandoz’s Zarxio (filgrastim-sndz). The…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
In the future, mAbs may represent a smaller percentage of the pipeline as portfolios concentrate more on development of antibody fragments, nanobodies, biosimilar protein therapeutics, conjugated prot…
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Ensuring the Quality of Biologicals
moved into the 21st Century, it increased its activity in the biological field to address increasing numbers of biologicals and challenges driven by development of biosimilar products.
Pharmacopei…
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Trends in BioPharma Approvals in 2013
Biosimilars
While the advent of approved biosimilar products remains a future prospect in the US, European regulators…
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Perfusion in the 21st Century
Now, improved continuous culture technologies such as perfusion are on the rise, as biosimilar manufacturers look for new ways to cut costs while increasing quality and productivity.
With perfusio…
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Managing Biomanufacturing Capacity Expectations
These findings could have implications for future demand calculations for biologics, as well as biosimilars with numerous market competitors—especially if the Centers for Medicare and Medicaid Service…
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New Era for Generic Drugs
Generic drugs now account for more than 85% of US prescription drug use, and the development of biosimilars promises to extend this trend to large molecules. Such transformation was unanticipated back…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
One possibility is in the development of biosimilar products. President Trump has promised to repeal and replace the Affordable Care Act (ACA), but what impact might this have on biosimilar developmen…