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

Key Practical Points

  • 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

Key Speakers

Suzette Kox

Secretary General at Int. Generic and Biosimilar medicines Association)

Nikolai C Brun

Chief Medical Officer at Danish Medicines Agency

Gillian Woollett

Senior Vice President at Avalere Health

Roman Ivanov

Vice President, Research & Development at BIOCAD

Thanks to our Sponsors

Hotel Venue

Porto Palácio Congress*****

Porto, Portugal


The Palácio is located in Porto’s upmarket area of Boavista, around two miles (three kilometres) from the city’s main square, Aliados. Therefore, accessing Porto’s key attractions requires a bit of legwork or transportation by taxi or public transport. The Casa da Música metro stop is a 12-minute walk away, however and buses to the city centre stop outside the building. Many cafés and shops can be found in the area, including the trendy indoor market Mercado Bom Sucesso.

The 251-room Palácio is first and foremost a business hotel and thus lacks the historic charisma of some of Porto’s other accommodation options. Nevertheless, it has a sleek and sophisticated feel that will appeal to those who enjoy travelling in style. Porters in chauffeur hats wait at the hotel entrance to whisk luggage through the revolving glass doors, and inside, mirrored lifts and gold chandeliers decorate the expansive lobby.