Biosimilars & Biologics 2018


On 22 & 23 March 2018, Porto will host the 2nd BioTech Pharma Summit: Biosimilars & Biologics 2018. 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 2018


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 2018 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
  • Biosimilar development in emerging markets
  • 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
  • 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
  • Injection Devices for Biosimilars: Advantages of Platform Products



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 group registrations or sponsorship enquires, please contact

President at the National Authority of Medicines and Health Products (INFARMED), PT
Medical Director at Norwegian Medicines Agency, NO
Vice President at PAREXEL
Erin Federman Mylan BioTech
Head of Biologics, Europe at Mylan
Head of Commercial Operations, Biotechnology at Gedeon Richter
Bryan Kim Samsung Bioepis
Vice President of Business Development at Samsung Bioepis
Omar Ali
Visiting lecturer at University of Porstmouth
Hazel Gorham
Clinical Pharmacology and Biosimilars Development at PRA Health Sciences
Former Vice-President INFARMED (National Authority of Medicines and Health Products)
Transformational Health Partner and Senior Vice President at Frost & Sullivan
Andreu Soldevila
Founder at LeanBio
Head of Global Tech RA at Boehringer Ingelheim
Founder at Integrated Biopharma & Pharma Solution
Director at Challand Biosimilar Consulting Ltd., UK
Account Director at Ypsomed AG
Owner & Principal at BioPhama Law Group, PLLC
Dairine Dempsey
CEO & co-founder at Open Orphan DAC
Uwe Gudat
Head of Safety, Biosimilars at Fresenius Kabi SwissBioSim GmbH
Life Sciences Global Director, Biopharma Services Development at SGS
Michael Muenzberg
Former Medical Director at Amgen Europe and member of the Comparative Outcomes Group
Document Package
Buy Ticket

Access to all event presentations

*Subject to speaker's approval for distribution



Special offer: Discounted travel with Lufthansa Group Partner Airlines

Lufthansa Group Partner Airlines offer a comprehensive global route network linking major cities around the world. We offer special prices and conditions to participants, visitors, exhibitors, invited guests as well as employees of the Contracting partner and their travel companions.

To make a reservation, please click on and enter the access code BEZJEPQ in the "Offer for discounted flights" area. This will open an online booking platform that will automatically calculate the discount offered or provide you with an even better offer if another promotional fare is available.

NOTE: Pop-ups must be enabled otherwise the booking platform window will not open.

These promotional fares are also available through your IATA / ARC travel agent. Travel agents can obtain ticketing instructions by sending an email to and providing the access code.

Event Details
  • FairJourney Biologics Logo