Search results for " biosimilars" in Articles / App Notes
Article
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
Lorimer (Patheon Biologics): The greatest regulatory change in recent times is the acceptance and approval of biosimilars.
BioPharm: What business trends have positively or negatively impacted biop…
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Biopharma in 2015: A Year for Approvals and Innovations
The approval came via the new biosimilars pathway established under the Biologics Price Competition and Innovation Act. As of September 2015, FDA received six biosimilar applications to reference prod…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Currently developed biosimilars, such as human growth hormone, insulin, and erythropoietin, are chemically far simpler than mAbs. It is unlikely that blood or plasma-derived products or complex vaccin…
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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…