Conference Agenda

14th Biosimilars Global Congress 2022 Europe

Day 2: Tuesday 8th November 2022

Current Regulatory Landscape

  • Critical aspects of the global Biosimilar market such as vendor landscape, competitive strategies, market drivers and challenges
  • Changing market dynamics within the Biosimilars market
  • The (relatively) welcoming EU environment vs. the US quagmire
  • The patent dance - or the last waltz for US biosimilars?

Peter Wittner, Senior Consultant, Interpharm Consultancy

  • EU law supporting biosimilars in the EU, and the basis for EU approvals.
  • The main EU guidelines.
  • Biosimilars post-Brexit.

Ray Cresswell, Pharmaceuticals and Biotech Lawyer

  • Do they add to our knowledge about the safety and efficacy of biosimilars?
  • Phase 3 Studies in Biosimilars: Statistically Speaking
  • More Pressure on Postmarketing Surveillance

Cecil Nick, Vice President (Technical) PAREXEL

10:40 am - Morning Networking & Refreshment Break

Access, Collaborations and Commercial Strategies

  • The ways to a high uptake: Five essentials
    • Belief in Science
    • Health Authorities
    • Procurement, Tenders and Pricing
    • Stakeholder participation
    • Information to patients
    • A miracle - or just common sense and cooperation?

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

  • Current Environment is constantly changing
  • Health systems are seeing the benefits
  • Patient impact should be a major consideration
  • How do we keep competition in the market

Dr. Steinar Madsen, Medical Director, Norwegian Medicines Agency*

  • Significantly invest in the training of medical professionals, including nurses
  • Develop patient information/assistance programs
  • Partner with patients’ organizations and regulators
  • Economically incentivize patients to accept a biosimilars prescription
  • Consider patients as partners, and no longer as “subjects”

Xavier Fraise, Principal, F.-X. Frapaise Pharma Consulting, Former VP. Clin Dev. Merck

12:50 pm - Networking Lunch

  • Contracting and rebates practices by reference products manufacturer
  • High manufacturing complexities, development costs and market uncertainties
  • Delay in regulatory pathway and rigorous regulatory requirements
  • Lack of information and experience among healthcare professionals and patients


Yariv Hefez, VP, Global Head Oncology Marketed Products, Merck Group

  • What are the trends driving adoption, pricing and reimbursement?
  • Evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access
  • Current climate for price discounting, is a uniform price possible
  • Increasing role of patient group whose voices are to be heard

  • What are the trends driving adoption, pricing and reimbursement?
  • Evolving methods for managing specialty product utilization and reimbursement toward ensuring appropriate access
  • Current climate for price discounting, is a uniform price possible
  • Increasing role of patient group whose voices are to be heard

3:20 pm - Afternoon Networking & Refreshment Break

  • Regulatory and clinical considerations in emerging markets
  • Operational issues in emerging markets
  • Biosimilar trends in Emerging market
  • Challenges and opportunities in emerging market countries

  • Strategies for overcoming barriers to biosimilar adoption
  • How can biosimilar developers, patients, healthcare proffesionals and payers conspire to establish a sustainable biosimilar 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

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)