Day 1
15th Biosimilars & Biologics World Congress 2025 Europe
The Evolution of Biologics & Biosimilars: Reducing Costs and Improving Accessibility
Hilton London Kensington, London, United Kingdom
Thursday 4th - Friday 5th September 2025
Andreas Seidl, Chief Scientific Officer, Formycon
LANDSCAPE & CURRENT TRENDS
- Innovation, collaboration, and regulatory agility are key factors in shaping the accessibility, affordability, and quality of biosimilar therapies.
- New development and commercial models that can help offset the impact of price declines and rising competition
- Emerging new ventures who are creating an impact on the global market with their latest innovations and technologies.
- Reducing barriers to market entry and promoting global access to biosimilar therapies.
- Why Post-marketing pharmacovigilance is needed for biosimilars?
Moderator:
Panelist:
- Innovation and Differentiation in the context of Biologics and Biosimilars
- Emerging trends in Discovery and Development
- Promises, pitfalls and potential
Anita Krishnan, AVP, Head of Analytical Sciences, Biosimilars, Biocon Biologics
- Current situation in biosimilar development
- Eligibility – when could a tailored approach be envisaged
- Streamlined approach – what would and would not be asked for
- Current Stakeholder Engagement Initiatives and how you could participate
René Anour, Chair, EMA BMWP & Senior Medical Assessor, AGES, Austria
- The 20-year Biosimilar Journey
- What have we learnt after 2 decades of biosimilar launches?
- Perspectives for the future
Caroline Boulliat, CEO & Founder, Genchrome Limited (Former Biosimilar Country Manager
Amgen– & Global Team Lead Biosimilar –Pfizer)
- An overview on data analytics and digitalization
- Discuss what are the challenges
- User cases that we have implemented
- What we could have inferred all along: taking a Bayesian view
- A more favourable “prior” than generally appreciated
- The power of “indirect evidence” and the confidence it provides
Empirically confirmed (updating the “posterior”): to date no surprises - Improved assay sensitivity and what it tells us looking back
- Where do we go from here: implications for streamlined biosimilar development
Uwe Gudat, Chief Medical Officer, Biocon Biologics Limited
REGULATORY AND CLINICAL DEVELOPMENT
- Poor sensitivity of Phase III endpoints ?: ACR 20/50/70 in the ARMADA trial (Humira®)
- Originator is a moving Target: Originator batches used as template for designing cQAs sometimes do not match with batches, used as reference in biosimilar PhIII trials
- The needle in the haystack – clinical data as surrogate for critical quality attributes, not appropriately tested in the comparability exercise ?
- Comparability for hypothetical modes of action – Limits of operational feasibility ?
- Extrapolation of bioequivalence from healthy volunteers to patients ?: Addressing target mediated/time-dependent clearance ?
- Potential impact of alternative formulations and new materials, encountering drug product, on immunogenicity ?
- Clinician’s perception of biosimilars, approved without PhIII clinical testing: Deja-vu of the experiences made with the extrapolation exercise ?
Dr. Bernd Liedert, BL Consulting, formerly PEI/EMA, Merck KGaA, Boehringer Ingelheim,
Sandoz/Hexal
- Navigating phase 3 development in emerging countries
- Managing speed vs cost
- Some lessons learned
Chris Bell, Executive Director, Worldwide Clinical Trials
- CETs add significant cost and delay to the development of biosimilars, the time is ripe to re-examine their need
- This presentation examines the need for CETs focussing on anti-TNF biosimilars.
- Structural differences between biosimilars and reference products are detectable at levels well below those that could impact clinical outcomes
- In vitro potency testing is fully capable of revealing clinically relevant differences without need for CETs.
- Pharmacokinetic (PK) studies robustly address potential concerns relating to PK and immunogenicity
Cecil Nick, Vice President (Technical), PAREXEL
- For biologics/biosimilars, Analytical Characterization and particularly product-specific Critical Quality Attributes have long been considered as the α and ω of biosimilarity assessment.
- Recent experience (CSPC and others) have showed that some observed differences between reference product and biosimilars on some analytical parameters (e.g. glycosylation) do not have clinical consequences (efficacy, safety,PK).
- Hence, in this context, the notion of “Totality of Evidence “, used by most key-Agencies seems to represent the most relevant approach.
Xavier Frapaise, Principal, F.X. Frapaise Pharma Consulting
- Challenges and obstacles faced by manufacturers in developing biosimilars
- How to overcome challenges, increase development success and optimize result
- Techniques in bringing the next generation of Biosimilars to the market
- Reducing capital investment and creating cost effective and scalable manufacturing operations
Moderator:
Panellist:
