Abstract book 6th RMS 16.indd

This presentation will give a brief profile
of Celltrion, including biosimilar’s
facility and product pipeline including
eight candidates in immunology and
oncology areas. Additionally, the
speaker will talk about the biosimilar’s
future global regulatory strategy
and will introduce global MAA (BLA)
submission plan which applies to 149
countries in North America, Europe,
Russia, CIS, Asia, MENA, Africa,
and Latin America regions. Lastly,
quality comparability and nonclinical
testing results of CT-P13, CT-P06
and CT-P10 will be introduced to
support physicochemical, functional
and nonclinical comparabilities of
Celltrion’s mAb biosimilars to the
reference products.
Celltrion is a biopharmaceutical
company which has more than 10
years of experiences specializing
in monoclonal antibodies (mAb).
Celltrion’s facility is certified by U.S.
FDA cGMP, and is the largest mAb
production facility in Asia. Celltrion’s
certified facility and high technology
are qualified for developing complex
mAb biosimilars.
This year EMA has published the
regulatory guidelines for biosimilars
of complex biologics and the US
FDA as well posted the first draft of
biosimilar guideline. Following the
official EMA and other countries’
guideline establishment including
US FDA’s, many biopharmaceutical
companies including Asian companies
have ramped up their efforts to
gain entrance into this regulatory
approval pathway, especially for mAb
biosimilars. Celltrion successfully
developed mAb biosimilars in terms
of structural as well as functional
comparability so far. Celltrion consults
with EMA to plan and conduct global
clinical trials as a step-wise approach
and the global clinical phase III trials of
two mAb biosimilars were successfully
completed by following strict EMA
guideline. Recently, the Korea FDA
approved CT-P13 (Celltrion’s infliximab
biosimilar) which is the world-first mAb
biosimilar. Celltrion is now awaiting
a series of approvals world-widely,
including EMA.
S07
Implementation of the Agility 160
leaf MLC - Initial Experience of its
Clinical Advantage
(Sponsored by Al Faisaliah Healthcare Systems
Co.)
Guests:
Chris Walker MD (UK)
Moderators:
Sameer Khraisat MD
Belal Hiari MD
Date: Tuesday 20/11/2012
Time: 17:00 - 18:30
Hall: Hall K
Repeated on:
Date: Wednesday 21/11/2012
Time: 11:30 - 13:30
Hall: Hall K
Venue: KHBTCC
The James Cook University Hospital,
Middlesbrough procured four new
matched Elekta Agility linacs in 2010
with the intention that three would
be installed in a newly constructed
department in June 2011 and the
fourth would replace an aging machine
in the existing department in late 2012.
A partnership was entered into with
229 www.jrms.gov.jo