Short Abstract

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

Biosimilars progress in the EU and USA: What EU lessons learnt can be useful for the USA? How are Biosimilars and Biobetters doing in Europe? Are they gaining acceptance?

In spite of the rich and varied 9 years of European experience of biosimilars, the FDA follows its own unique course and finally is now testing its regulatory framework. The new FDA BsUFA Advisory meetings in a first step would determine eligibility of a new biosimilar candidate after which fees are charged for 4 other meetings. These new FDA steered development programs have not been proven yet.

The first 351k ABLA reviews by the FDA of filgastrim Zarzio (approved March 2015), infliximab Remsima, and Retacrit ongoing in 2015 will be illucidated. The key role Advisory Committees in all biosimilars approvals will be discussed. Also, insulin glargine approved under a MAA (EU) and subsequently under a NDA(b2) (US) will be clarified.

What genuine opportunities are there for harmonised US/EU and worldwide development of a Biosimilar or Biobetters?

What are possible pricing and market penetration strategies in the US, mainly based on the EU experience, and Granix and Zarzio GCSFs in the USA?

The selection of reference product dosage form and presentation has become more strategic than ever 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.

EMA and FDA approval requirements will be compared and contrasted, and as well as insights into commercialization of Biosimilars in Europe will be discussed. Controversies and hurdles of regulatory approvals, medical acceptance, and Health Care Provider effectiveness will also be critically considered.

The EU biosimilars experience has influenced the regulators view of all biologics worldwide and led to new sophistication.

EMA clinical basis of approval of 2013, 2014 biosimilars of new product therapeutic classes monoclonal antibodies (infliximab), fertility (FSH) and insulins (glargine) and the current pipeline opens up exciting opportunities. Two monoclonal antibodies, and two other proteins are under EMA review.

The implications of the FDA Purple Book towards US interchangeability of biosimilars with originator biologics will be presented. Interchangeability and switching perceptions in US and EU will be highlighted.

What are the barriers and drivers of biosimilar adoption in the US? What is the implication of the first biosimilar approval in the USA? What kind of impact is expected for stakeholders? Will it afford FDA new momentum and opportunities for new sponsors? How is the EU consolidating its experience with this new class of medicines at the EU Commission, EMA, Health Care Provider level and Prescriber levels?