Biosimilar Registration Requirements & Process

Duration: 4 weeks (Course: 8 hours, Assessment: 2 hours)

Can be taken individually: Yes

Learning Objectives

By the end of the course, learners will be able to:

• Understand the CTD structure of a biosimilar dossier.

• Write and review key CMC sections.

• Present analytical similarity data clearly and scientifically.

• Write clinical overview and clinical summary sections.

• Justify extrapolation of indications.

• Prepare comparator bridging justifications.

• Identify common deficiencies in biosimilar dossiers.

• Draft responses to regulatory questions.

Weekly Topics

Week 1: Structure of the Biosimilar Dossier

• CTD and eCTD structure

• Module 1: country-specific administrative requirements

• Module 2: summaries and overviews

• Module 3: quality documentation

• Module 4: non-clinical documentation

• Module 5: clinical documentation

• Differences between biosimilar and innovative biologic dossiers

• Key writing principles for biosimilar submissions

• Consistency between modules

Week 2: CMC and Analytical Similarity Writing

• Writing the Quality Overall Summary

• Describing the manufacturing process

• Presenting process development data

• Writing the control strategy

• Presenting analytical similarity data

• Preparing CQA tables

• Justifying acceptance criteria

• Summarizing analytical method validation

• Writing stability summaries

• Presenting forced degradation data

• Common CMC writing gaps

Week 3: Clinical and Non-Clinical Writing

• Writing the clinical overview

• Presenting the clinical development rationale

• Explaining residual uncertainty

• Writing PK/PD study summaries

• Presenting comparative efficacy data

• Presenting safety data

• Writing immunogenicity sections

• Justifying reduced clinical data packages

• Writing non-clinical waiver justifications

• Linking clinical conclusions to analytical similarity

Week 4: Integrated Regulatory Argumentation

• Writing the biosimilarity conclusion

• Justifying extrapolation of indications

• Writing comparator bridging justifications

• Explaining minor differences versus the reference product

• Addressing uncertainty in the dossier

• Preparing responses to regulatory questions

• Writing concise deficiency responses

• Final dossier review checklist

• Submission-readiness assessment

Assessment

• Quiz and Q&A