Search results for " biosimilars"
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Ensuring the Quality of Biologicals
The first biosimilar was approved in Europe in 2006, and there are now 20 biosimilars authorized in Europe. Importantly, the Ph. Eur. provides a framework for the quality requirements for biosimilars …
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Trends in BioPharma Approvals in 2013
This brings the total number of biosimilars approved thus far in Europe to 19. This total, however, represents a comparatively more modest 10 genuinely different products, as several are marketed unde…
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Perfusion in the 21st Century
The biosimilars market is growing at a healthy rate (5), yet it is also extremely competitive.
Many manufacturers of branded biologics are shifting their focus from blockbusters to smaller-volume,…
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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
There are more than 700 biosimilars approved or in the pipeline globally. Analysts expect the worldwide biosimilars market to reach $25 billion to $35 billion by 2020.2 Many experts recall Trump’s cri…
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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
Breakthroughs, biosimilars, and bottlenecks
Many of the new molecular entities—41% of the approvals in 2014 and 47% of the approvals in 2015—were for rare diseases that target smaller patient popu…
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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…