Short Abstract

The seminar will provide essential scientific, regulatory and business perspectives of a complex field for executives. Medium to advanced level.

Past experiences of FDA regarding 10-20 year biologics approvals has paved the way to entry of biosimilars – therefore, a new paradigm is emerging, not only with an emerging new class of products but also a fresh Pharma and Regulator awareness of novel recombinant therapeutic proteins including monoclonal antibodies. Development strategies of a new generation of selective biologics including Biobetters are emerging. Also, Regulators worldwide now demand a higher quality standard of biologics.

What EU lessons learnt can be useful for the USA? How are Biosimilars and Biobetters doing in Europe? Are they gaining acceptance? What are pricing and market penetration strategies? In spite of the rich and varied 8 years of European experience of biosimilars, the FDA follows its own unique course. The new FDA BsUFA Advisory meetings in a first step would determine eligibility of a new biosimilar candidate after which meeting fees are charged. What genuine opportunities are there for harmonised US/EU and worldwide development of a novel biologic or Biobetter or Biosimilar? The selection of reference product dosage form and presentation has become more strategic than in the past years with a view to a streamlined international development US/EU/Rest-of-world reducing multiplication of effort and resources, and providing compliance advantages to the patient. Controversies and hurdles of regulatory, medical acceptance, Health Care Provider effectiveness will also be critically considered.