Featuring

15th Biosimilars & Biologics Global Congress 2025 Europe

Strategies, Innovations and Collaborations for Sustainable Biosimilars

Days
Hours
Minutes
Seconds

19th - 20th May 2025
Hilton London Olympia, London, UK

Venue

Hilton London Olympia

Address

380 Kensington High St, London W14 8NL

Phone

020 7603 3333

15th Biosimilars & Biologics Global Congress 2025 Europe

Biosimilars market in Europe, having reached the most advance stage in the process globally is still continuously gathering strength. In the recent year alone, 19 biosimilar therapeutic medicines had been granted marketing authorization, which brings over 40 EC-approved biosimilar products in the current market. Europe is bound to have another remarkable year of biosimilar approvals and launches in this coming year with EMA’s pipeline of biosimilar candidate reviews rapidly increasing.

The 15th Biosimilars & Biologics Global Congress, will cover a diverse range of topics that addresses the Strategies, Innovations and Collaborations for Sustainable Biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more. 

Read Full Introduction
Insights & Attendees
Past Attendees

Featuring Key Industry Experts

Burkhard Pieper

Global Scientific Officer, Biogen Biosimilars Unit (BBU)

Mark Samuels

Chief Executive, British Biosimilars Association

Cecil Nick

Vice President (Technical) PAREXEL

Dr. Steinar Madsen

Medical Director, Norwegian Medicines Agency

All Expert Speakers

Testimonials

I was really impressed with the congress organization and the audience who represented top biosimilars experts worldwide. I believe the event offered an excellent platform for sharing insights and points of views of the different stake holders from both the industry and the regulators’ sides. Would certainly want to participate next year
Dr Mourad FaroukMedical Director @ International Development
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 MartinAssociate 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. ManziPhD, Managing Director, Atheln, Inc
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 BerriosERP/ CRM / Product Configurator Manage
The 2014 Biosimilars Global Congress stimulated collaborative discussion to facilitate advancing the science and medicine for biosimilar product access for patients
Dr. Nancy MartinVP, Clinical Development, Hospira
It was a pleasure presenting at this year’s conference and thank you very much for the excellent organization.
Rovert FriesenVP and Head, Biologics Research @ Janssen
Many thanks for your support at the Congress last week, I found the meeting extremely informative and the Paradigm team absolutely fantastic!
Costantino CongiatuPhD, Senior Specialist, Regulatory Affairs
PGE organizes an International, high quality conference packed with highly relevant presentations by EMA biosimilar assessors, biosimilar developers and originators with a high degree of delegate interaction
Richard Di CiccoCEO @ Harvest Moon
Great conference, varied and very relevant material. Great speakers and organizers. Was worth attending. Looking forward to next year’s event
Dr. Hanane CherifQuality and Compliance Director
A very interesting conference. Comprehensive programme. Highly qualified speakers
Dr. David UguenExec. Director, Voisin Consulting Life Sciences
Very useful knowledge exchange
Marcus MreyenDirector @ Protagen Protein Services
Fantastic speakers, very informative event
Agnieszka KulescaClinical Operations Manager @ Biovirtus Research Site
Very informative Conference
Dr. Adrian HainesSenior Principal senior Scientist @ Lonza Biologics
Great interactive discussion with experts in their field.
Dr. Fiona GreerGlobal Director, SGS M-SCAN
The program is very informative, far more comprehensive than others of this type
Renita RathinamLawyer, Sughrue Mion PLLC, Litigation
The event provided a lot of different point of views about the same topic (Biosimilars)
Gabriela ScarpaProduct Manager, Marketing, Janssen
Paradigm organizes a packed high quality agenda with high quality industry and EMA assessor speakers
Richard DiCiccoChairman, Harvest Moon Pharmaceuticals USA
Previous
Next
View Conference Agenda

Global Talent Partner:

Biosimilars market in Europe, having reached the most advance stage in the process globally is still continuously gathering strength. In the recent year alone, 19 biosimilar therapeutic medicines had been granted marketing authorization, which brings over 40 EC-approved biosimilar products in the current market. Europe is bound to have another remarkable year of biosimilar approvals and launches in this coming year with EMA’s pipeline of biosimilar candidate reviews rapidly increasing.

The increasing pressure to decrease healthcare expenditures, growing demand due to its cost-effectiveness, expanding occurrence of different diseases, increasing numbers of biologics losing their market exclusivity, positive outcomes in ongoing clinical trials and rising demand in various therapeutic applications are all contributing factors for growth of the biosimilars market. Other factors increasing the demand for biosimilar drugs include rising disease incidences across the globe and better access to healthcare for all nations.

However, circumstance such as high manufacturing complexities and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.

The 14th Biosimilars Global Congress, will cover a diverse range of topics that addresses the Strategies, Innovations and Collaborations for Sustainable Biosimilars. This will also offer and provide a unique platform for knowledge sharing and convergence from Pharmaceuticals, Biotechnology, Regulatory and many more.

We are honoured to welcome you to London in November!

Jocelyn Raguindin
Jocelyn Raguindin

Jocelyn is Conference Director at Paradigm Global Events (PGE). She has over 17+ years experience in organizing pharma-industry conferences and has been at the helm of every PGE conference since 2013. Jocelyn is based in London, UK.

Gain Latest Insights on:

  • Learn the current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to themarket
  • Know the strategies in place in developing and manufacturing biosimilars
  • Establishing and integration of biosimilarity and comparability into developing Biosimilars
  • Identify challenges encountered with Extrapolations and interchangeability, assessing immunogenicity and Pharmacovigilance
  • Study the pre-clinical and clinical challenges associated with the development of biosimilars
  • The importance of establishing partnerships and successful collaboration for Biosimilars business
  • Learn the latest updates, trends and current Biosimilars market situations in different regions
  • What does the future hold for Biosimilars and Biologics
  • Network with experts and leading drug developers, regulators and investors in the industry

TARGET AUDIENCE:

  • Pharmaceutical and Biotech Companies
  • Pharma Associations & Societies
  • Biotechnology Experts/Business Entrepreneurs
  • Research and Development Scientists
  • Intellectual Property Attorneys
  • Ph.D. and Post Doctorate Scholars

Who Should Attend:

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

¨ Follow on Biologics/Biosimilars

¨ Biologics/Biotechnology/ Biogenerics

¨ Biopharmaceuticals/ Biotherapeutics

¨ Legal Affairs

¨ Pricing and Reimbursement

¨ Clinical Immunology

¨ Regulatory Compliance

¨ Research & Development

¨ Preclinical and Clinical Development

¨ New Product Development

¨ Quality Affairs/ Quality Control

¨ Principal Scientist

¨ Pharmacovigilance

¨ Chief Scientific Officer

¨ Drug Safety & Risk Management

​

Who Attends

The 14th Biosimilars Global Congress 2022 Europe, will provides a unique platform for the convergence of stakeholders in the biosimilars industry to discuss and network with top tier government, hospitals, pharmaceuticals, biopharmaceuticals, non-profit organizations, biosimilar developers as well as regional and local manufacturers. Our event delegates include Chief Executives, Executive Directors, Vice Presidents, Heads, Team Leaders & Managers from a range of organisations including..

AbbVie Canada – Abbvie – Abzena – AGES MEA – Alliance for Safe Biologics – Amgen Inc – Applied Photophysics Ltd – Arecor – Avalere Health – AstraZeneca – Barclays – Bates White – Baxalta Inc – Baxalta US Inc – Baxter Healthcare – Benchworks Inc – Biocad Brazil – Biocad Russia – Bioeq – BioFactura Inc – Biogen Idec – Biogen International GmbH – Biogen – Biologics Consulting Group Inc – BIOMEDICA – BioPharm Insight – Biopharmaspec Inc – BioVirtus – BioWorld Today – Bird and Bird – Boehringer Ingelheim – Bristol Myers Squibb – Caprion – Cardinal Health – Charles River Laboratories – Chatfield Pharmaceuticals Ltd – CIMA Industries SA – Cipla Ltd – Clearside Biomedical – Clinigen CTS – CMC Biologics A/S – COFEPRIS – Consumer Health Forum of Australia – Cook Pharmica LLC – Deutsche Bank – Dr. Reddy’s Laboratories – Drinker Biddle & Reath – Durbin Global – Dyadic International (USA) Inc – EMD Millipore – EMD Serono – ENCB-IPN – Epirus Biopharmaceuticals – Eurofins Lancaster Laboratories – FirstWord – Fresenius Kabi – Fujifilm Diosynth Biotech – Fujifilm Kyowa Kirin Biologics Co. Ltd – GE Healthcare Life Sciences – Genentech – Geolab Pharmaceutical Industry – Glyconex – Granzer Regulatory Consulting & Services – Grupo Farmaceutico Somar – GSK – Hanwha Biologics – Hanwha Chemicals – Harvest Moon Pharmaceuticals – Hospira Inc – IMS Health – Innovent Biologics Inc – Intra – Cellular Therapies Inc – inVentiv Health Clinical – Janssen Inc – JHL Biotech Inc Taiwan – KLJ Associates – Lake Partners – Libbs Farmaceutica – Lifescience Dynamics – Lonza Biologics PLC – Lupin Pharmaceuticals India – mAbXience – Medimmune – Merck & Co – Merck Biosimilars – Merck Millipore – Merck Serono – Merck Sharp & Dome Ltd – Merck – Merckle GmbH – Milliman – MITSUBISHI GAS CHEMICAL COMPANY INC – Momenta Pharmaceuticals Inc – Multipharma – Mylan – Myoderm – Napp Pharmaceuticals – Nippon Kayaku Co Ltd – NIPTE – Norwegian Medicines Agency – Novo Nordisk – Omnicare Pharma GmbH – Orygen Biotechnologica – PARAXEL International – Patheon – PCI Pharma Services – Pfizer Inc – Plexus Ventures Limited – PPD – PRA Health Sciences – PRA International – Probiomed S.A de C.V – Protagen Protein Services GmbH – Qually Corporacion S.A de C.V – Queens University – Ratiopharm – Roche Farmaceutica – Sanape LLC – S &Oz Inc. (a Novartis Company) – Sciex Separations – SciMentum – SGS Group Ltd (USA) – SGS Life Sciences Services – SGS M-Scan Ltd – Shanghai CP Guojian Pharmaceutical Co Ltd – Spectrum Paharmaceuticals – SPL – Stefantech Systems Inc – Sterne Kessler Goldstein & Fox P.L.L.C – Sughrue Mion PLLC USA – Sun Pharmaceuticals Industry Ltd – Taylor Wessing LLP – Teva Pharmaceuticals – Texcell – Therapeutic Proteins International LLC – Toxikon Europe – Transformity – University Alkharh EDU – Virdispharma – Voisin Consulting Life Sciences – West Pharmaceutical Services Inc – Woodley Bio Reg Ltd – Wyatt Health Management – YAKUMED – Ypsomed AG – ZOTEK King Lai Co. Ltd (KunShan)

Burkhard Pieper

Global Scientific Officer, Biogen Biosimilars Unit (BBU)

As Scientific Officer of the BBU Global Headquarter in Baar, Switzerland, Dr. Burkhard Pieper is responsible to advance the scientific understanding of biosimilars across stakeholders and to support early accessibility of biosimilars to patients eligible for the treatment with biologics. In his role he is collaborating with key medical experts, scientific societies and organizations, and patient advocacy groups across several therapeutic areas and geographies.  
Since 2015 he was heading up the BBU Global Scientific Affairs team, leading the medical and scientific launch readiness for our anti-TNF and anti-VEGF portfolios.  

Mark Samuels

Chief Executive, British Biosimilars Association

Mark Samuels is the Chief Executive of the British Biosimilars Association and its sister body, the British Generic Manufacturers Association, representing the companies that supply four out of five medicines used by the NHS.

Mark’s career has spanned diverse experiences across the life sciences sector. He is a former executive at Roche and co-founded the Medicines Discovery Catapult Ltd. He was the founding Managing Director of the government’s Office for Clinical Research Infrastructure – instrumental in managing the Department of Health’s £0.6 billion/year investment in research centres across the NHS. Mark served for seven years on the Chief Medical Officer for England’s strategy board for health research, and he has worked with Number 10 to contribute to the Prime Minister’s strategy for life sciences.

Mark is a graduate of QMUL and Oxford’s Saïd Business School. He has also held a Policy Fellowship at Cambridge University.

Cecil Nick

Vice President (Technical) PAREXEL

Gained BSc (Hons) in Biochemistry from University of Cape Town and has been working in regulatory affairs and clinical development for over 30 years; for the last 25 years focused on biological medicines. Particular expertise in monoclonals and biosimilars, having worked on over ten such programs and participated extensively in Industry and International meetings on the subject.

 

Joined PAREXEL in February 2001 and has been involved with issues relating to clinical development, regulatory submissions, biosimilars, orphan drugs and training. In the last five years alone has worked on scores of clinical development plans connecting the input from pharmacologists, statisticians, therapeutic experts, and feasibility analyses to craft development plans which are effective, highly efficient and achievable with extensive experience in the field of inflammatory disease.

 

Cecil has particular expertise in regulatory, biotechnology and clinical development and is a well-known expert on biosimilarity and comparability. Most recently Cecil has been extensively involved in the development of monoclonal biosimilars and has supported a number of global marketing applications. He has been a frequent international speaker and author on the topic of biosimilars and comparability.

Dr. Steinar Madsen

Medical Director, Norwegian Medicines Agency

Dr. Steinar Madsen, is medical director at the Norwegian Medicines Agency.

He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology. He has been working with generic substitution since it was introduced in Norway in 2001. He is member of a working group at the Agency that is looking into several aspects on the regulation of generic substitution in Norway, including biosimilar drugs, with the aim of a better legal framework. Dr. Madsen is also engaged in the Agency’s drug information service, with a special interest in the safe use of drugs.