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Recorded Webinar
Essential Biosimilars Perspectives for Indian Pharma Companies: European Experience of Regulatory Submissions Development and Registration of Biosimilars Medicines 2002-2010
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This presentation will provide unique and fresh insights and perceptives into the practicalities and experiences of the pharmaceutical, nonclinical and clinical development of Biosimilars.
European and American pioneering experience of the presenter permits identifying success factors for Biosimilars development internationally. The presenter had a leading role in the submission and approval of one of the first of two biosimilar approvals in Europe and the Western world, a somatropin (rhGH) in April 2006. Since then he has been engaged in consulting for a number of companies in the full development of other biosimilars: interferons, GCSF, EPOs, insulin’s, FSHs, heparins and monoclonal antibodies (mAbs) etc.
The lessons learned will be shared with delegates and practical tips will be provided. Therefore, the pitfalls that need to be anticipated and the proactive measures taken to avoid them will be addressed from both a European and International perspective. Safety considerations which are uppermost in the regulators and physicians mind when prescribing a Biosimilar to start a patient on therapy or switch a patient from a existing biologic to a Biosimilar will be highlighted.
That is, factors affecting interchangeability and substitution will be clarified.
Predicting immunogenicity effects using a limited database requires skill and good scientific and empirical reasoning. This will be put in context.
A variety of tips will be provided to increase the sponsors chances of marketing approval success and reduce overall risk to the program.
To conclude, the presentation and follow up discussion will identify success factors for Biosimilars development in an international setting, based on European experience.
Who should attend
- Head/VP/Director of R&D Pharmaceutical/Biotechnology.
- VP / Director of QA
- Clinical Operations.
- Green chemistry professional/Consultant
- Director regulatory clinical Quality and Regulatory
- VP / Director of Pharmaceutical/Healthcare/Biotechnology
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