Development of Biosimilar Products: Determinants of Success

50 %
50 %
Information about Development of Biosimilar Products: Determinants of Success
Health & Medicine

Published on June 15, 2013

Author: a2zpharmsci



After leaving FDA my focus has been on practicing QbD to deliver, in highly uncertain business environments, complex products and the necessary scientific evidence. This presentation comments on firm's ability to successfully develop and introduce into markets.

BIOSIMILARS: ONTHEREALMOFREALITYDETERMINANTS OF SUCCESSAjaz S. Hussain, Ph.D.Chief Scientific Officer, Wockhardt Ltd.2013 AAPS National Biotechnology ConferenceBIOTEC Open Forum5/20/2013 1Ajaz S. Hussain, Ph.D.

This is my personal point of view5/20/2013 2B.Pharm.CSO VP BiopharmaceuticalsCSODeputy DirectorOffice of Pharmaceutical ScienceAssociate Professorof Pharmaceutics (tenured)Assistant Professorof PharmacyPh.D.InterdisciplinaryAjaz S. Hussain, Ph.D.

This presentation reflects my current interest• After leaving FDA my focus hasbeen on practicing QbD bycontributing to building• effective multidisciplinary teams,• business decision processes andtechnical infrastructure• To deliver, in highly uncertainbusiness environments, complexproducts and the necessaryscientific evidence• Sandoz• Biosimilars and complex generics(e.g., enoxaparin) – within aGerman/Swiss org. environment• Philip Morris International• Plant based vaccines and MRTP’s –QbD systems in a “non-pharma”sector (Swiss org. environment)• Wockhardt• Biosimilars and NCE’s – Indian org.environment5/20/2013 3Ajaz S. Hussain, Ph.D.

An information-theoretic definition: SimilaritySimilarity between Aand B may be measuredby the ratio betweenthe amount ofinformation needed tosate the commonality ofA and B and theinformation needed todescribe what A and BareA way to think about the challenges indeveloping, and communicating about,biosimilarsD. Lin (1998). Ajaz S. Hussain, Ph.D. 4

Add a comment

Related presentations

Related pages

Development of Biosimilars: Determinants of Success A ...

Development of Biosimilars: Determinants of Success ... challenges that need specific considerations for successful development of biosimilar products.
Read more

Biosimilars: On the Realm of Reality Determinants of Success

Quality of development and regulatory communication Design Product & process Specifications & controls Product use information Understanding Acceptable
Read more

Biosimilar | LinkedIn

... Merck Serono Biosimilar Development at ... A biosimilar product is a biological product ... Development of Biosimilar Products: Determinants of Success.
Read more

Biosimilars - U S Food and Drug Administration Home Page

A biosimilar product is a biological product that is ... about biosimilars, ... Guidance for the Development and Approval of Biosimilar ...
Read more

The Biosimilars Group

... from candidate identification to marketed product. ... The Biosimilars Group offers as a new and ... for full biosimilar development project ...
Read more

Biologics | Biosimilars | Pharmaceuticals & Medical ...

... providing the focused guidance and counsel necessary to position your new product for success. ... biosimilar product development plan is to ...
Read more

Intas Biopharmaceuticals - Wikipedia, the free encyclopedia

Intas Biopharmaceuticals Limited was set up in ... programs are at advance stage of development, ... launches its first biosimilar product in ...
Read more