AI Article Synopsis
- Biosimilars in rheumatology are now established and require thorough clinical trials to ensure efficacy and safety.
- The trials must use specific statistical methods, like equivalence and non-inferiority, to demonstrate similarity.
- The text also compares recent approvals of biosimilars with biomimics, which are non-innovator biologics lacking the same regulatory scrutiny.
Article Abstract
Biosimilars are now a reality in rheumatology. Although analytical and non-clinical procedures to establish similarity have evolved significantly, clinical trials demonstrating equivalent efficacy and safety are absolutely required for all biosimilars. The design of such trials, including equivalence and non-inferiority statistical approaches, are discussed. Clinical evidence on biosimilars that have been approved recently or are presently being developed for use in rheumatology is also reviewed and contrasted with that available for biomimics (or intended copies), which are non-innovator biologics that are marketed in several countries but have not undergone review according to a regulatory pathway for biosimilars.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4613175 | PMC |
| http://dx.doi.org/10.1136/rmdopen-2014-000010 | DOI Listing |
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