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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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[Biosimilars versus original biologics. Similarities and differences from development to approval].
1Sandoz Biopharmaceuticals (a Novartis company), Biochemiestr. 10, 6250, Kundl, Österreich. joerg.windisch@sandoz.com.
Zeitschrift Fur Rheumatologie
|September 2, 2015
Summary
Biosimilars offer significant healthcare savings and expanded patient access to biological medicines. Strict European Medicines Agency (EMA) approval ensures their safety, quality, and effectiveness are comparable to original biologics.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Biotechnology
- Regulatory Science
Background:
- Patent expiries for biological pharmaceuticals are increasing biosimilar approvals.
- Biosimilars are projected to generate substantial savings in the European Union, estimated between €11.8-33.4 billion in 2020.
- The rise of biosimilars signifies a major shift in pharmaceutical markets and healthcare economics.
Purpose of the Study:
- To understand the inherent variability of biological substances and the clinical significance of product attributes.
- To establish proof of comparability as a core concept in biosimilar development and approval.
- To evaluate the importance of extrapolating data to other indications once comparability is established through comprehensive studies.
Main Methods:
- Assessment of European Medicines Agency (EMA) regulations for biosimilar approval.
- Evaluation of analytical, physicochemical, and biological methods for determining comparability.
- Analysis of permissible deviations from reference products in biosimilar development.
Main Results:
- Biological pharmaceuticals exhibit natural variability (e.g., glycosylation) and manufacturing processes can lead to batch or process differences.
- Biosimilars must meet stringent approval criteria, ensuring their attributes fall within the variability range of original biologics.
- Biosimilars demonstrate proven safety, quality, and effectiveness comparable to reference products, with minimal deviations.
Conclusions:
- The biosimilar development and approval framework has been validated over nearly a decade.
- Stringent EMA requirements ensure high-quality biosimilars.
- Biosimilars have led to significant healthcare cost savings and improved patient access to biological medicines globally.
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