Biosimilars

Regulatory requirements for approval of a conventional biologic and a biosimilar are different. The biosimilar approval pathway has a more extensive analytical development phase compared to a biologic, whereas the pre-clinical/clinical pharmacology/clinical studies efforts are more extensive during the development of a biologic.

IBR Inc. has longstanding experience in development of biosimilars including Head-to-Head Comparability studies under GLP and GCP quality standards in accordance with regulations (EMA, FDA, ICH).

Our Biosimilar Services

IBR Inc. is capable to support your biosimilar project from Quality Target Product Profile, QTPP to Head-to-Head Comparability studies (quality, non-clinical and clinical studies) including equivalence testing and lot to lot consistency.

Within the Quality Target Product Profile, QTPP phase, IBR Inc. can support:

  • Method development and validation
  • Analysis of stress and non-stress samples of Originator
  • Evaluation of critical quality attributes, CQAs
  • Risk assessment and design development

Method validation is performed according to ICH Q2 (R1) guidelines and bioassays are evaluated according to statistical and tiered approaches (e.g. EU/EMA: min-max approach and USA/FDA: 95% confidence interval approach for biologics; 90% CI for biosimilars). Tiered approaches are based on the classification of critical quality attributes and risk ranking relevant to clinical outcome, that determine what type of testing is required for comparison.

IBR Inc. also supports Head-to-Head Comparability of Originator and Biosimilar with:

1. Comparative quality studies

    Functional: biological/pharmacological activity

    Analytical: physical/chemical properties (e.g. long term stability)

2. Comparative non-clinical studies

    Pharmacodynamic, Toxicology

3. Comparative clinical studies

    Pharmacokinetic/pharmacodynamics and Efficacy/Safety/Immunogenicity

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