Search results for "biosimilar"
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.
Article
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…
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…
Article
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…
Article
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…
Article
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…