Assess analytical and functional similarity data against a reference product's critical quality attributes.
Healthcare & Pharmaceutical Management
Biosimilar Development and Market Access Strategy
Equip biopharmaceutical and market access teams to plan a biosimilar's analytical, clinical and commercial pathway from similarity assessment through to payer negotiation and post-launch uptake.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
A biosimilar succeeds only when analytical evidence, clinical data and commercial strategy are built as one continuous case rather than three separate workstreams that meet for the first time at launch. This course follows that case from the laboratory bench to the formulary decision. Participants examine how analytical and functional similarity to a reference product is established, how regulators weigh a totality-of-evidence package under EMA and FDA biosimilar frameworks, and when comparative clinical and pharmacokinetic studies add meaningful evidence rather than duplicate it. The programme then moves into extrapolation of indications, interchangeability determinations and the naming and traceability rules that follow a biosimilar after approval. On the commercial side, participants build a payer engagement plan, model tendering and contracting scenarios, and design physician and patient communication that supports switching without undermining confidence. The result is a single, defensible development and access strategy rather than a set of disconnected regulatory and commercial documents.
Expected Learning Outcomes
Evaluate when comparative clinical or pharmacokinetic studies are needed to complete a totality-of-evidence package.
Determine which indications can be supported by extrapolation rather than dedicated clinical trials.
Build a payer engagement plan that addresses health technology assessment requirements for biosimilars.
Design a pricing and tendering approach that reflects multi-stakeholder contracting in biosimilar markets.
Plan physician and patient communication that supports switching decisions without eroding confidence.
Set up post-approval pharmacovigilance and traceability processes specific to biosimilar products.
Who Should Attend
Biopharmaceutical regulatory affairs professionals leading biosimilar submissions.
Market access and pricing managers building biosimilar launch strategies.
Medical affairs staff preparing physician and patient switching communications.
Health system and payer representatives evaluating biosimilar formulary decisions.
Pharmacovigilance officers responsible for biosimilar traceability reporting.
Commercial and portfolio strategists assessing biosimilar investment opportunities.
Course Modules
Select any module to see its sessions and points.
01Biosimilar Science and Regulatory Pathways
2 sessions · 8 points
Session 1Analytical and Functional Similarity Assessment
- Compare a candidate molecule's structural and functional attributes against the reference product's specifications.
- Interpret orthogonal analytical methods used to demonstrate similarity in structure and biological activity.
- Identify quality attributes most likely to affect clinical performance and prioritise them in a comparability plan.
- Build a stepwise data package that moves from analytical to nonclinical evidence of similarity.
Session 2Regulatory Pathways and the Totality-of-Evidence Approach
- Compare the EMA biosimilar guideline framework with the FDA 351(k) abbreviated licensure pathway.
- Assess how much clinical evidence a totality-of-evidence package still requires after strong analytical similarity.
- Plan a scientific advice meeting that tests the proposed development pathway with regulators early.
- Map regional differences in reference product sourcing rules across major biosimilar markets.
02Clinical Development and Interchangeability Evidence
2 sessions · 8 points
Session 1Designing Comparative Clinical and PK/PD Studies
- Design a pharmacokinetic and pharmacodynamic study capable of detecting clinically meaningful differences.
- Select a sensitive patient population and endpoint for a comparative efficacy and safety study.
- Justify statistical equivalence margins that regulators will accept for a biosimilar comparison.
- Plan immunogenicity assessment appropriate to the reference product's known immunogenic risk.
Session 2Extrapolation of Indications and Interchangeability Determinations
- Build the scientific justification needed to extrapolate data to indications not directly studied.
- Assess mechanism-of-action and pharmacokinetic similarity across patient populations for extrapolation.
- Determine the additional switching study evidence required for an interchangeability designation.
- Prepare a briefing document that presents the interchangeability case to a regulatory review team.
03Market Access and Commercial Strategy
2 sessions · 8 points
Session 1Payer Engagement and Health Technology Assessment for Biosimilars
- Prepare a health technology assessment submission that positions a biosimilar's value against the reference product.
- Address payer questions about clinical equivalence, safety monitoring and real-world evidence expectations.
- Map the formulary decision process across hospital, insurer and national payer stakeholders.
- Build a value dossier that communicates cost and outcome trade-offs to non-specialist decision-makers.
Session 2Pricing, Tendering and Multi-Stakeholder Contracting
- Model pricing scenarios that account for reference product discounting and multiple biosimilar entrants.
- Structure a tender response that balances volume commitments against supply continuity risk.
- Negotiate contracting terms with hospital groups, insurers and group purchasing organisations.
- Assess the commercial impact of gain-share or outcomes-based agreements on biosimilar uptake.
04Uptake, Pharmacovigilance and Lifecycle Management
2 sessions · 8 points
Session 1Physician and Patient Education to Support Switching
- Design physician education materials that explain the comparability evidence behind a switching recommendation.
- Prepare patient communication that addresses common concerns about switching to a biosimilar.
- Plan a phased switching programme that monitors clinical response during the transition period.
- Coordinate nursing and pharmacy teams on administration differences between reference and biosimilar products.
Session 2Post-Approval Pharmacovigilance and Traceability Management
- Apply naming and batch-traceability conventions that let adverse events be attributed to the correct product.
- Design a post-authorisation safety study appropriate to a biosimilar's residual uncertainty.
- Build a signal detection process that distinguishes class effects from product-specific safety signals.
- Report switching and interchangeability outcomes back into the product's ongoing risk management plan.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
Complete your registration
We will contact you within one business day to confirm.
Ready to start?
Reserve your seat and start building the skill.