Search results for " interchangeability"
Article
Biosimilar Quality Requirements
…ssment and Other Quality-Related Considerations (1) and the guidance Considerations in Demonstrating Interchangeability with a Reference Product Guidance for Industry (2).
Congress created an app…
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Driving Improved Access to Biosimilars
Establishing interchangeability has required additional clinical studies. So far, Boehringer-Ingelheim has been the only company to have pursued a US strategy that combines basic biosimilar approval a…
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Moving Biosimilars Forward in a Hesitant Market
Interchangeability
Another point that a biosimilar developer must contend with is interchangeability, Bukhari also points out. For example, with a small-molecule drug, it is simple to replace that d…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Biosimilars and the impact of FDA guidance
BioPharm: Regarding biosimilars, there have been some changes in the US, with FDA setting requirements for analytics and for interchangeability…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Levine whether he thought the new FDA guidelines presented challenges for interchangeability. “First of all, other than saying that FDA will consider interchangeability after one has demonstrated bios…
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FDA Approves First Biosimilar
Biosimilar, but not interchangeable
While the approval is based on strong evidence, says FDA, the agency is careful to state that the biosimilarity designation does not imply interchangeability. A…
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Prescribing Caution for Biosimilars
In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicin…
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Biosimilars to Drive Modern Manufacturing Approaches
And new guidance documents are scheduled on standards for achieving product interchangeability, statistical analytical approaches for documenting product similarity, and managing post-approval manufac…
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The Bullish Outlook for Biosimilars
In the dynamic biosimilar business segment, however, such an understanding is crucial for optimal market access because regulatory pathways and policies around interchangeability and automatic substit…
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An Analytical Approach to Biosimilar Drug Development
In fact, all of the biosimilars approved in the United States are considered by current legislation to be new biological products without official interchangeability with the reference product. FDA ha…