Biosimilars Seminar/Workshop
Status of the New Biosimilar Product

מרצה: Dr. Hoss Dowlat

תאריך: 14, 15 מרץ 2018
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות: 9:00-17:00
עלות: 4,300 ש"ח + מע"מ
נקודות זכות: 2
מק''ט: 18849
שפת הקורס: אנגלית
על הקורס

Executive Perspectives of the US/EU, FDA/EMA and international Class, Insights, Landmark, Approval Requirements and Opportunities

What EU lessons learnt can be useful for the USA and how are Biosimilars and Biobetters advancing in Europe, USA and internationally?

Are they gaining acceptance?

In spite of the rich and varied 11 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 up to 4 other categories of meetings. These new FDA-steered biosimilar development programs have not been proven yet.

The first 351k BLA reviews by the FDA of filgastrim Zarzio (approved March 2015), and monoclonal antibody infliximab, involved Medical Advisory Committees (ADCOM). Also, insulin glargine was approved as a biosimilar under a MAA (EU) in 2013 and subsequently, as a follow-on biologic, under a NDA(b2) (US). Further 351k BLA approvals in 2016 and 2017 have been eternacept, adalimumab, trastuzumab and adalimimab.

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

What role does quality and in vitro nonclinical studies play?

What clinical studies are expected and why?

The selection of reference product dosage form and presentation from earliest development 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. Controversies and hurdles of regulatory approvals, medical acceptance, and Health Care Provider effectiveness will also be critically considered.

קהל היעד
  • Overall: Managers, Directors, VPs interested (planning or actively working in the space) in current perspectives on biosimilars and biologics/biotech medicines
  • Business development
  • Marketing
  • Drug development
  • Regulatory affairs EMA, FDA and international
  • Clinical development
  • Nonclinical development
  • Quality and pharmaceutical development
  • Chemistry, manufacturing and control, development QC & QA
Biosimilars Seminar/Workshop 
Status of the New Biosimilar Product
התועלת שתופק
  • Overview of the biosimilars progress in the EU and USA
  • EMA and FDA Biosimilars approval requirements will be compared and contrasted
  • Guidelines on the Development of a biosimilars program
  • Review of safety and immunogenicity nonclinical and clinical aspects
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • Overview
  • Biologics and Biosimilars FDA and EMA development and regulatory framework
  • General progress and penetration
  • Compare and contrast mindsets, guidelines and experience
  • Is WHO getting back on track with the EMA like it began in 2011?
  • Insights and practical applications including comparability
  • Quality testing & confirmatory in vitro as foundation of biosimilarity; current requirements including Tiering of Quality Attributes and statistical criteria
  • Nonclinical development: too much, too little?
  • Leveraging in vitro and in vivo studies
  • Huge logistic challenges of clinical work in biosimilars
  • Merits of EMA Scientific Advice or FDA BsUFA meetings
  • Developing a Biosimilars Program with US or EU focus:
    • What to consider?
    • Building on EU biosimilar landscape
    • Lessons learned from past EU and US experience e.g GCSF, insulins, mAbs and more
    • Definitions of biosimilars, interchangeability, switching
    • Building on new biologics intelligence in biosimilars development
    • Examples of monoclonal antibodies and other therapeutic proteins such as insulins
  • Is there change of mindset in the US (since 2012) or EU (since 2006)?
  • Expectations
  • Safety and immunogenicity nonclinical and clinical aspects
  • Closing Q&A – Future Prospects
אודות המרצה

Dr. Hoss Dowlat

Dr. Dowlat leads an international team of drug development Principal Consultants at his self-owned PHARMABIO CONSULTING.
His experience encompasses strategic regulatory support and Due Diligence to circa 90 client Pharma companies and international management consulting and pharmaceutical service companies from across Europe, America, Canada, China, Korea, Taiwan, Japan, and India and the financial sector New York US and London UK.

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