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


Individual Registration

Ticket FeesSuper Early Bird*Early Bird*Discounted TicketNormal Ticket
Due DateUntil December 14Until February 15Until March 8After March 8
Industry Fee1495 Euros1695 Euros1795 Euros1995 Euros
Academic/Investor/NPO500 Euros600 Euros650 Euros850 Euros
Premium Package2800 Euros3000 Euros3250 Euros3550 Euros

*The 3rd Annual Biosimilars & Biologics 2019 is an exclusive limited seat event. Super Early-Bird/Early bird tickets are non-refundable and subject to availability.

Group Registration:

Team DiscountsUntil December 14Until February 15Until March 8After March 8
2 Delegates10%5%----
3 Delegates15%10%5%--
4+ Delegates20%15%10%5%

Coupon Codes: (Use the coupon code below while doing the online registration)

Coupon CodesAcademic/NPO/InvestorIndustry FeePremium Package
Super Early BirdRFSW19RKRE19JKREA19
Early BirdNot AvailableNot AvailableNot Available
Discounted TicketNot AvailableNot AvailableNot Available

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

Senior Vice President at Avalere Health, US
Founder at Karyo Biologics, Adello Biologics and Pharmaceutical Scientist, LLC, US
Senior Director International at Biosimilar Medicines Group, Sector group of Medicines for Europe, BE
Chief Medical Officer. Director of Division at Danish Medicines Agency, DK
Founder and President, Arthritis Consumer Experts, CA
Vice President R & D, Global Head, Biologics Safety Assessment, MedImmune, US
Group Leader/Principal Investigator at iMed-The Research Institute for Medicines, PT
Patent Examiner at European Patent Office, DE
Director of the Brazilian National Health Regulatory Agency (ANVISA), BR
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
President at the National Authority of Medicines and Health Products (INFARMED), PT
Chief Scientific Officer at Bioceros, NL
Chief Medical Officer Fresenius-Kabi SwissBioSim, CH
Associate Professor of Rheumatology & Head of the Rheematology Unit at the Federal University of Paraná, BR
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
Risk Management expert for Biosimilars at Boehringer Ingelheim, DE
Vice President and Head, Business Development & Licensing at Cipla Limited, IN
Industry Package
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One-on-One Meetings

Business Lunches

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VIP Airport Pick-Up

Pre-Conf. Workshop

Accommodation in Superior Room

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3m2 Exhibition Space

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Book Bag Inserts

Gala Dinner

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Challenges in designing and developing innovative Business models for Biosimilar and Biobetter industry

Value-cocreation with Biobetters

Biosimilars and Biobetters in social media, the attractivity challenge

*Workshop is just valid if you purchase a package (Industry/Academic)