Search results for " biosimilars"
Article
Using Multiple Techniques in Biosimilar Analysis
Whether they are called ‘sameness’ for generic drugs, ‘comparability’ for biologics, or ‘analytical similarity’ for biosimilars, these tests are crucial for any regulatory submission, which is vital t…
Resource
EMA scientific guidance documents on biosimilar medicines
This page lists the scientific guidance documents on biosimilar medicines from EMA.
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Now that biosimilars are here to stay, manufacturers are developing processes for cost efficiency and reliability using newer technology to compete with innovator products based on processes 10-15 yea…
Article
EMA Collaborates with HTA Assessment Networks
The Impact of HTAs on Biosimilars
As a result of cuts in healthcare costs due to post-recession austerity programs, favorable HTAs are becoming crucial to the successful market launch of pharmace…
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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
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 …