3rd Annual Biosimilars & Biologics 2019


On 21 & 22 March 2019, Porto will host the 3rd BioTech Pharma Summit: Biosimilars & Biologics 2019. This year’s flagship event will gather top EU, US, Asia and global regulators, officials, healthcare actors as well as industry leaders, to foster open exchange and debate on the role of the biosimilars & biologics medicines sector.

Over 200+ proteins, peptides and biosimilars delegates representing leading biotech companies, global pharmaceutical organisations and internationally renowned academic institutions at the Biosimilars & Biologics 2019


With more U.S., Europe biosimilars continuing to receive FDA/EMA approval, it is critical that bio/pharmaceutical companies develop strategies to comply with evolving regulations, mitigate risk and execute long-term decisions to prepare for success.


Over 20 presentations and case studies focusing on the key areas of the biosimilars industry including market access strategies, clinical development, commercialisation, manufacturing and bio-analytics


Biosimilars will lead to $54 billion less in direct spending on biologics (or about 3% of total spending on biologics) over the next decade. The range of the new savings estimate given reasonable ranges of key assumptions, such as the price of biosimilars versus reference biologics and biosimilar market share, varied from $24 billion to $150 billion from 2018 through 2027.


The BioTech Pharma Summit: Biosimilars & Biologics 2019 is the leading event to continually stay on the pulse of the biosimilars’ ever-changing market and convenes key stakeholders including biosimilar and innovator pharmaceutical manufacturers, payers, providers and patient advocates addressing timely challenges and best practices for biosimilar product success


  • Interchangeability strategy in Biosimilar clinical trial
  • Biosimilars Market Access in the EU
  • Biosimilar development in emerging markets
  • Regional updates from the US, Middle East and Africa
  • Overview of FDA Guidance on Biosimilars
  • CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
  • Prognosis for the Global Biologics market in an era of transformative new technologies
  • Innovative clinical approach in biosimilars
  • Critical Analytical Characterization Steps for Biosimilarity Assessment
  • Process Development for Biosimilars – Industry challenges
  • Biosimilars development and impact on clinical practice
  • Analytical Biosimilarity and Data Quality for Manufacturers of Biosimilar for the US Market
  • Biosimilars: Challenges in Safety and Risk Management
  • Impact that biosimilars make on availability of biologicals on ROW markets
  • Biosimilar approval to biogenerics in clinical practice
  • Pricing and reimbursement considerations for Biosimilars
  • Commercial challenges and opportunities – strategies to develop Biosimilars & Biologics
  • Developing successful business models in Biosimilar product development
  • Understanding the current regulatory approval standards for Biosimilars in Europe, US and ROI including for monoclonal antibodies



The BioTech Pharma Summit (EPM Group) are exclusive events designed for senior level attendees from leading pharmaceutical, biopharmaceutical, biotechnology, diagnostics, CRO and solution provider companies, along with highly esteemed members of academic and government institutions. Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers including:

  • Biologics/Biotechnology/ Biogenerics
  • Biopharmaceuticals
  • Business Development
  • Chief Scientific Officer
  • Clinical Immunology
  • Commercial Affairs
  • Drug and Safety Assessment
  • Drug Safety & Risk Management
  • Intellectual property
  • Legislation and Policy Advice
  • Manufacturing Market
  • Strategy Marketing & sales
  • New Product Development
  • Pharmacovigilance
  • Preclinical and Clinical Development
  • Pricing and Reimbursement
  • Health Economics
  • Principal Scientist
  • Process Control and Analytical Technologies
  • Quality Affairs/ Quality Control
  • Regulatory Affairs
  • Regulatory Compliance
  • Legal Affairs
  • R & D

*For Sponsorship/Exhibition enquires, please use the contact form below.

Head of Information and Strategic Planning Office at INFARMED, PT
Chief Development Officer at Bioceros, NL
Health Surveillance and Regulation Specialist at ANVISA, BR
Director, Policy & Market Access at Mylan, PT
Senior Vice President at Avalere Health, US
Secretary General of IGBA (International Generic and Biosimilar medicines Association), BE
Chief Medical Officer. Director of Division at Danish Medicines Agency, DK
Group Leader/Principal Investigator at iMed-The Research Institute for Medicines, PT
Professor of Cancer Medicine and Oncology at Imperial College London, UK
Program Director at Biologics and Biosimilars Collective Intelligence Consortium, US
Leader, Pharmacy & Health Provider Relations at Green Shield Canada, CA
Chief Medical Officer Fresenius-Kabi SwissBioSim, CH
Commercial Research Initiative Manager at NIHR Clinical Research Network Coordinating Centre, UK
Vice President, Research & Development at BIOCAD, RU
Medical Director at Norwegian Medicines Agency, NO
Chief editor at Biosimilar Development, US
Resident of Rheumatology at Centro Hospitalar de Lisboa Ocidental, EPE PT
Vice President and Head, Business Development & Licensing at Cipla Limited, IN
Francois-Xavier Frapaise
Former Vice President Clinical Development, Drug Safety and Medical Affairs at Merck, FR
Director at Challand Biosimilar Consulting Ltd., UK
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