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Sep 19, 2017 · Nonclinical in vivo studies are conducted after analytical characterization of the biosimilar, and are designed to address any specific residual analytical uncertainty and, in some jurisdictions, ensure safe use in humans.
- Carol F. Kirchhoff, Xiao-Zhuo Michelle Wang, Hugh D. Conlon, Scott Anderson, Anne M. Ryan, Arindam B...
- 10.1002/bit.26438
- 2017
- 2017/12
Feb 11, 2024 · The FDA states that a comparative clinical study is necessary “if there is residual uncertainty about whether there are clinically meaningful differences” between the proposed biosimilar and the RP, “based on structural and functional characterization, animal testing, human PK and PD data, and clinical immunogenicity assessment” . The ...
- 10.3390/ph17020235
- 2024/02
Oct 3, 2018 · If any residual uncertainty over biosimilarity remains thereafter, an additional comparative clinical study (or studies) of efficacy and safety may be required to further evaluate whether there are any clinically meaningful differences between the biosimilar candidate and the reference product. 17 It is likely that studies of human safety and ...
- Michael Epstein
- 10.1177/1756284818799600
- 2018
- 2018
- Entering The Next Wave of Growth
- Transform R&D Processes Through Digital Technologies
- Monitor The Industry Landscape and Prepare For Change
- Strengthen The Foundations by Enhancing The R&D Operating Model
In an earlier article, we examined the impressive growth in biosimilars from 2015 to 2020 and outlined the key strategic considerations for the next wave of growth.1Ying Chen, Alex Monnard, and Jorge Santos da Silva, “An inflection point for biosimilars,” June 7, 2021.McKinsey’s market forecast model for biosimilars indicates that double-digit glob...
Companies have scope to pursue digital innovation at several points (such as the expression system) in drug development, if the need for similarity can be met and the new processes produce a molecule that can interact with the desired receptors. Digitization is still in its early stages in the biosimilar industry. But some companies have already im...
As more biosimilars were launched over the past decade, regulatory guidelines have evolved. Different regulatory agencies take slightly different approaches. Looking forward, we expect to see changes in two major areas—Phase III trials and interchangeability studies—that could have a profound impact on industry dynamics.
Biosimilar companies can enhance their R&D operating model in three main areas: processes, outsourcing, and talent allocation. Let’s look at each. Process optimizationcan help companies not only to accelerate time lines and cut costs but also to promote collaboration, increase the focus on key processes and bottlenecks, and improve ways of working ...
relevant PD biomarker to demonstrate PD similarity can reduce residual uncertainty. • At least 1 clinical study that includes a comparison of the immunogenicity
Sep 21, 2019 · Residual Risks: To estimate the residual uncertainty about similarity and assess robustness of the chemistry, manufacturing, and controls (CMC) filing package, several lots of both products (reference and similar) are compared.
People also ask
What is the clinical assessment of a biosimilar to a reference product?
How are biosimilars developed & evaluated?
How is the purity of a biosimilar determined?
How is a biosimilar compared with a reference product?
The residual uncertainty of safety, immunogenicity, and efficacy of biosimilars that has shaped the current regulatory guidelines is now substantially reduced. This will allow the re-evaluation of the non-clinical and clinical requirements of the current WHO main guideline.
