FDA to Address Industry Questions About Biosimilar Regulations at the Pharma's IQ Immunogenicity Event

LONDON, April 5, 2011 - This May, Joao Pedras-Vasconcelos, Visiting Associate,
Therapeutic Proteins CBER from FDA will meet with European industry experts
at Pharma IQ to discuss FDA directives on immunogenicity introduced in
2008.

Over the last two years, the regulations have been subject
interpretation. Although the regulations were released in 2008, there has
been some confusion within the industry as the regulations are subject to
interpretation. The confusion arises around the tests have to be developed in
order to get approval to develop a drug with a suitable level of
immunogenicity.

Joao will provide the attendees with the reviewed FDA
regulations and an analysis of the FDA implementation policy. He will also
discuss how new FDA guidelines will influence the product development and how
companies could make the most out of the pending regulations.

During his presentation, he will also assess the changing
regulatory landscape and the practicalities of regulatory approval
establishing relationships between immunogenicity assay development studies.

FDA session, Regulatory Update: An FDA Guidance for Industry;
Understand Policy and Ensure Assay Development Within the Guidelines, will be
part of the 2nd Annual Immunogenicity: Prediction, Detection and Effective
Assay Development
(www.iqpc.com/Event.aspx?id=463610&utm_campaign=PR&utm_medium=online&utm_source=PR&MAC=18464.002PR3)
event, taking part 30 May - 01 June 2011 in Munich.

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Other key sessions include:

- Implementing the correct immunogenicity assay for successful
drug development with an A-Z of everything you need to know with Dan
Sikkema, GlaxoSmithKline

- Ensuring global regulatory compliance with key insights from Joao
Pedras-Vasconcelos, FDA and Meenu Wadhwa, NIBSC

- Discovering novel in vitro and in vivo assay techniques to
improve immunogenicity prediction methods with Bruce Green, Pfizer

- Effectively applying theory to practice with insights into
comparative immunogenicity studies with Birgit Reipert, Baxter

- Keeping up-to-date with industry advances with clinical updates
on the role of compliment in nanomedicines and biologicals with Janos
Szebeni, Nanomedicine Research and Education Center, Bay Zoltan
Foundation

- Case Study: Developing Safe and Efficacious Drugs: How
immunogenicity is impacting clinical affects of drug development and
safety by Andrew Yates Senior Group Leader, Drug Research & Development
UCB

- Case Study: Developing Standardised Assays to Allow Direct
Comparisons of the Immunogenicity of Innovator Products and Biosimilars

If you want to find out more, please visit
www.immunogenicity-event.com/PR, email enquire@iqpc.co.uk or call
44(0)207-368-9400.

    CONTACT:

    PHARMA IQ
    Joanna Checinska
    email: joanna.checinska@iqpc.co.uk
    phone: 44(0)2073689300

CONTACT: PHARMA IQ, Joanna Checinska, email: joanna.checinska at iqpc.co.uk, phone: 44(0)2073689300