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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Epoetin biosimilars in Europe: five years on
Ashraf Mikhail1, Mourad Farouk
1Morriston Hospital, Morriston, Swansea, West Glamorgan, UK. Ashraf.Mikhail@wales.nhs.uk
Advances in Therapy
|December 18, 2012
Summary
Biosimilar epoetins (HX575 and SB309) approved by EMA require careful consideration due to potential molecular differences. Healthcare providers must evaluate post-authorization data for long-term safety and efficacy when switching treatments.
Area of Science:
- Pharmacology
- Biotechnology
- Drug Development
Background:
- Biosimilars, including erythropoiesis-stimulating agents (ESAs), are not identical to reference products.
- Regulatory standards for biosimilar approval differ from generic drugs.
Purpose of the Study:
- To review published data on two epoetin biosimilars (HX575 and SB309).
- To highlight considerations for healthcare providers assessing epoetin biosimilars.
Main Methods:
- Analysis of pharmacokinetic and pharmacodynamic equivalence studies.
- Review of phase 3 clinical comparability evaluations.
- Examination of post-authorization studies and quality comparisons.
Main Results:
- Two epoetin biosimilars, HX575 and SB309, were approved by the European Medicines Agency (EMA) by late 2007.
- Reported differences in glycosylation profiles exist between biosimilars and reference products.
- Limited long-term safety and efficacy data are available.
Conclusions:
- Potential molecular and formulation differences necessitate comprehensive data analysis.
- Switching between ESAs and biosimilars should be managed carefully with clinician involvement.
- Prescribing by brand name is recommended for pharmacovigilance.
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