BioTech Pharma Summit: Biosimilars & Biologics 2019

21-21 March 2019 ∣ Porto Portugal

 

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 LEARNING 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

 

*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.

 

Contact us:

 

Diogo Lino Ribeiro

Tel: +351 915 239 640

Email: diogo.ribeiro@epmgroup.org