Search results for " biosimilar"
Article
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…
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Implications of Cell Culture Conditions on Protein Glycosylation
Special cell-culture considerations for biosimilars
Biosimilars are “generic” versions of protein pharmaceuticals that must be highly similar to the innovator drug in order to be classified as such…
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Outsourcing Trends in Biopharmaceutical Manufacturing
Trend four: Majority of biosimilars production could be outsourced
One area that might end up being mostly outsourced is biosimilars production. Contract manufacturing organizations (CMOs) are lik…
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Framing Biopharma Success in 2016
Peters
The US biopharmaceutical industry turned a new page in 2015 when FDA approved Zarxio (filgrastim-sndz), the first biosimilar approved for use in US markets, in March 2015. Biotechnology sto…
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Modular Manufacturing Platforms for Biologics
Modularization of biologics and biosimilars
Emerging markets and the increasing demand for biosimilars may prompt pharmaceutical manufacturers to adopt a “local sourcing” attitude that has histori…