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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
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A Comprehensive Overview on Biosimilars.
Vishruti Kadam1, Shapali Bagde, Manisha Karpe
1University of Mumbai, Bharati Vidyapeeth's College of Pharmacy, Department of Pharmaceutics, C.B.D. Belapur, Sector 8,Navi Mumbai- 400614, India. vishrutikadam91@gmail.com.
Current Protein & Peptide Science
|February 27, 2016
Summary
Biosimilars offer cost savings but require rigorous regulatory oversight due to complex manufacturing and potential immunogenicity. Their development and approval processes are more extensive than for generic drugs.
Area of Science:
- Biopharmaceutical manufacturing
- Drug development
- Regulatory science
Background:
- Biosimilars are similar, not identical, versions of originator biopharmaceuticals.
- Their market entry coincides with patent expiry of reference products.
- Complex manufacturing and inherent variability pose unique challenges.
Purpose of the Study:
- To discuss key aspects of biosimilars.
- To highlight regulatory considerations for biosimilars.
- To explore the potential of biosimilars in healthcare.
Main Methods:
- Review of regulatory guidelines for biosimilars.
- Analysis of manufacturing complexities.
- Discussion of immunogenicity and risk management.
Main Results:
- Biosimilar approval requires extensive data compared to generics.
- Immunogenicity and pharmacovigilance are critical safety aspects.
- Regulatory pathways for indication extrapolation, substitution, and interchangeability are stringent.
Conclusions:
- Biosimilars present significant research opportunities.
- Effective risk management plans and pharmacovigilance are essential.
- Biosimilars hold potential for substantial healthcare cost savings.
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