Due to changes in the patent cliff over the next 5 to 6 years, an enormous opportunity to develop “generic” versions of biologics, more commonly known as biosimilars has occurred.
In this white paper we focus on some of the key issues which should be considered when performing pharmacokinetic analyses to prove clinical comparability between innovator biologics and recently developed biosimilars. Topics covered include:
- Study design
- Acceptance limits used to conclude clinical comparability
- Immunogenicity (anti-drug antibodies)
- Elimination characteristics
- Relative protein contents of the test and reference drugs
- Benefits of using multiple region-specific reference drugs
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