15th Biosimilars & Biologics World Congress 2025 Europe

The Evolution of Biologics & Biosimilars: Reducing Costs and Improving Accessibility

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15TH BIOSIMILARS & BIOLOGICSCONGRESS 2025 EUROPE

The Evolution of Biologics & Biosimilars: Reducing Costs and Improving Accessibility

We are delighted to invite you to our 15th Biosimilars & Biologics Global Congress 2025. This annual event serves as a premier forum, bringing together influential individuals and pioneering thinkers from the biosimilar and pharmaceutical sectors. Our attendees include industry leaders, policy makers, regulatory experts, patient advocates, and healthcare professionals, all dedicated to expanding patient access and promoting the progress of biosimilar & biologic medicines within the wider healthcare frame work.

The growing importance of biological therapies is clear, offering significant health benefits while also posing considerable challenges related to healthcare funding, organizational frameworks, infrastructure, and global supply networks. Recognizing these evolving dynamics, effective biosimilar policies have become essential, delivering substantial value to the entire healthcare community by enabling broader access to these critical treatments.

This year’s Congress is structured as an engaging platform for comprehensive discussions on the most significant issues influencing the future of biosimilars. We will explore vital topics such as improving patient access to biotherapies, encouraging robust market competition, understanding the newest developments in regulatory science, and examining the transformative impact of biosimilar medicines on healthcare systems and the supporting industrial landscape.

We believe that the 15th Biosimilars and Biologics Global Congress 2025 will offer a valuable opportunity for knowledge acquisition, professional networking, and collaborative solutions. We eagerly anticipate your active participation in these crucial discussions, which will undoubtedly contribute to the ongoing advancement of biosimilar & biologic medicines and better outcomes for patients.

We look forward to meeting you at the Congress!

Sincerely yours,

Jocelyn Raguindin
Conference Director
Facilitate Live

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This Conference is designed for Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers working within:

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Key Industry Expert Speakers

Peter Jørgensen

CEO

The Danish Generic and Biosimilar Medicines Association

Xavier Fraise

Principal, F.-X. Frapaise Pharma Consulting

Former VP. Clin Dev. Merck

Cecil Nick

Vice President Vice President (Technical)

PAREXEL

Chris Bell

Executive Director

Worldwide Clinical Trials

Caroline Boulliat

CEO & Founder

Genchrome Limited

Dr. Bernd Liedert

BL Consulting

formerly PEI/EMA, Merck KGaA, BoehringerIngelheim, Sandoz/Hexal

Dr. Mourad F. Rezk

VP, Global Head, Medical Affairs & Development

Biogen

Dr Jeremy Morais

Medical Director UK, Ireland & Nordics

Fresenius Kabi Ltd

Anita Krishnan

AVP, Head of Analytical Sciences, Biosimilars

Biocon Biologics

Bobby George

VP, Group Head Regulatory Affairs

Reliance Life Sciences

Kalveer Flora

Pharmacy Lead, Rheumatology

London North West Healthcare NHS Trust

Mark Samuels

CEO

Medicines UK, British Biosimilars Association

Schedule

Content Rich Program Agenda!  Featuring Keynote Presentations, Stream Sessions, Panel, and Round Table Discussions.

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:

  • Innovations
  • Various potentials of biologics
  • Challenges in Biologics Production and Delivery
  • Promises and potentials
  • 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)

  • How Analytics and Mass spec became the driving force behind biotherapeutic drug development
  • Addressing key challenges, such as structural complexity, quality control, and regulatory demands
  • Potential to be realized for the implementation of mass spectrometry in biopharmaceutical development and manufacturing
  • An overview on data analytics and digitalization
  • Discuss what are the challenges
  • User cases that we have implemented
  • Foundation and impact
  • Steps in manufacturing process
  • Types of biologics
  • Role of biologics in Diseases treatment

REGULATORY AND CLINICAL DEVELOPMENT

  • Introduction
  • Biosimilar testing requirements
  • Evidence required to support indication extrapolation
  • Addressing data exclusivities and market exclusivities
  • Biosimilar substitution
  • 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:

PATIENT ACCESS AND AFFORDABILITY

  • Understanding biologics and their market potential
  • Developing a comprehensive go-to-market strategy
  • Regulatory considerations for biologics
  • Pricing and reimbursement strategies

Moderator:

Panelist:

  • Opportunities, threats and policy changes that impact the UK market
  • Moving from transactional to strategic approach is needed
  • Dedicated Biosimilar strategy required
  • Scaling up the relationship between Government And Industry

Mark Samuels, CEO, Medicines UK, CEO, British Biosimilars Association

  • Biologics had contributed to improving clinical outcomes across wide range of disease
  • Access to Biologics is still suboptimal in terms of overall access % and time of initiation
  • Biosimilars should be further leveraged to address these major access gaps and not just to help saving health care spending
  • Treatment guidelines should further emphasise the role of biosimilars and position them as first line Biologics to help maximising treatment outcomes.

Dr. Mourad F. Rezk, VP, Global Head, Medical & Development, Biogen

  • The role of health insurance plans in driving biosimilar adoption
  • Adoption and formulary challenges
  • Building data solutions for classifying and working with biosimilar drugs
  • Shifting reimbursement policies
  • Cross-functional strategy incorporating policy adjustments
  • Reducing coverage restrictions on biosimilars to improve accessibility and drive wider adoption, particularly for conditions with high treatment costs.
  • Education for healthcare providers and patients is also crucial
  • Fostering collaboration among key stakeholders
  • Overview of challenges faced by Biosimilars developer
  • Some factors that affect the sustainability of biosimilar policies
  • Elements that should underpin sustainable biosimilar policy development
  • Strategies to ensure optimal market sustainability and patient-focus.
  • Easy market access. All biosimilars enters the hospital market Day One after patent expiryHigh uptake. Within a few weeks they have a market share of 90+%
  • Increased patient care. Many more patients are now treated with biologic medicine – often 200+%
  • Sustainable health care budgets. Hugh savings – close to 10% of the total medicines budget for just a few products

Peter Jørgensen, CEO, The Danish Generic & Biosimilar Medicines Association

  • Considering internal requirements
  • Sharing decisions with patients and prescribers
  • Ensuring adequate supply
  • Patient and medical staff education
  • Other strategies and considerations
  • Biosimilars have the potential to significantly reduce the cost of biologic medications, improving affordability and accessibility for patients.
  • Increased competition in the biologics market, facilitated by biosimilars, can lead to greater access to essential medications for a wider range of patients.
  • Biosimilars can contribute to improved health outcomes for individuals with chronic and life- threatening diseases.
  • Strategies for overcoming barriers to biosimilar adoption
  • How can biosimilar developers, patients, healthcare professionals and payers conspire to establish a sustainable market
  • Importance of Physician and Patients input in shaping international standards for biosimilars
  • Policies in place to encourage physicians / pharmacist collaboration
  • Commercial potential and best ways on how to gauge such an opportunity in biosimilar

Moderator:


Panelist:

Register To Attend Now!

Take Advantage of the Super Early Bird Discount. Group Discounts Also Available. 

Testimonials

what people say

Thank you for a good experience with the PARADIGM Global Events… very high level, very good Organization, we overpassed our expectatives, we will be pending for another congress related to pharmaceutical and biotech… we learned a lot, and i think that the content of agenda was state of the art, thank you again.
Salvador Berrios
ERP/ CRM / Product Configurator Manager
The consistently high quality of international faculty was most impressive. It was also obvious that they were carefully chosen not only for their particular expertise but also for their ability to communicate the subject matter to clinical and non-clinical participants alike. As market access consultant for pharma clients of various sizes, I now feel much better prepared to explain the nuances & dynamics involved in bringing their products to market. In addition, I am in a much better position to intelligently advice my clients & help them set realistic expectations
Thomas Martin
Associate Vice President, VCGA - Quintiles
I was impressed with the organization of this event. I attend many conferences per year and find the organizers on site to be detached and not focus on good service to the delegates. This team was even providing weather forecast warning to ensure everyone was aware and made appropriate plans. Well Done.
Adriana E. Manzi
PhD, Managing Director, Atheln, Inc

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