Welcome to the 2nd Annual Biosimilars Summit

With patents for dozens of biologic drugs expected to expire within the next five years, the value of bringing biosimilar alternatives to the market has never been clearer for drug manufacturers. In the United States, the FDA has created an abbreviated licensure pathway for biosimilars, but many pharmaceutical companies and biotech firms struggle in understanding how-to:

  • Provide the pre-clinical and clinical data needed to demonstrate similarity
  • The speed and complexity of advancing a biosimilar drug development project
  • Design comprehensive clinical trials needed to prove safety and efficacy in humans

It’s because of this that we’re bringing you the 2nd Annual Biosimilars Summit. This upcoming February, we’ll be discussing some key insights from thought leaders into the biggest challenges in the analytical and clinical phases of biosimilar drug development, from addressing current regulatory struggles, demonstrating the quality attributes needed to prove interchangeability, and successfully entering the market. 

Download Agenda

Featured Speakers

View All Speakers

Is your company looking to streamline the processes for:

Engineering quality attributes in your biosimilar to demonstrate chemical characterization.

Engineering quality attributes in your biosimilar to demonstrate chemical characterization.

Proving product comparability at the In Vivo and In Vitro testing stages

Proving product comparability at the In Vivo and In Vitro testing stages.

Managing the additional bioanalytical data required by the FDA in the pre-clinical phase

Managing the additional bioanalytical data required by the FDA in the pre-clinical phase.

Designing effective clinical trial protocols that move your product from Phase I to Phase III

Designing effective clinical trial protocols that move your product from Phase I to Phase III.

Optimizing your operations for managing different clinical trial sites

Optimizing your operations for managing different clinical trial sites.

Demonstrating effective parameters for safety, purity, effectiveness and potency to the FDA

Demonstrating effective parameters for safety, purity, effectiveness and potency to the FDA.

The summit’s key presentations include such sessions as:

Pre-Clinical/Analytical

 

Testing the Molecule to Ensure Compatibility of Immunogenicity in the Human Body and the Drug

 

Preparing For the BsUFA: US Regulatory Landscape for Approving Biosimilars

 

Characterizing the Critical Quality Attributes of the Protein to Understand which Traits Are Imperative for the New Molecule

Clinical Study

 

Determining the Right Partnerships: Working Cohesively to Assess the Structure, Function and Bioanalytical Development to Prove an Accurate, Clean and Stable Molecule

 

Populating Your Clinical Trial: Determining Patient Interaction, Physician Input and Branding Practices to Market the Trial

 

Patient Selection: Picking the Right Patients for the Most Effective Clinical Trial

Market entry

 

Commercializing a New Product in an Emerging and Existing Market: What to Expect and How to Overcome the Regulatory Barricades

 

Addressing the After Effect: Policy, Payers and Pharmacy – Ensuring a Sustainable Biosimilar Market in the US Market

 

Educating the Market: Where do physicians fall and what are their concerns?

Testimonials

Sponsors & Exhibitors
Media Partners