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Fusion Biosimilars.
Using our geography to meet a new need….
From India through Asia, biosimilar production is a growing commercial activity. Starting initially with the Insulins
and mostly with Indian manufacturers, there are a large number of companies now producing all types of novel
biosimilars and large molecules. Our aim is to provide a full service to these companies to take their biosimilars
from conceptualisation through to Marketing Application in all major markets.By approaching us through the Fusion
system, we are able to apply the experts you need to provide all the services applicable to APAC.
� Regulatory support. Including taking your product through Regulatory submission in all major markets
including US FDA, EU, Japan and the New World markets. This task is performed by our Regulatory
Partners based in Europe. From programme design through pharmacovigilance and working closely with our
laboratory partners will design your immunogenicity package including method development and validation.
Our central laboratory will organise your global sample management.
� Introduction to manufacturing and formulation sites meeting local requirements.
The APAC countries have different requirements from one another. We will guide you accordingly depending
on the best site for your drug development programme.
� Development of Investigator brochure and Toxicology packages.
We will perform a gap analysis of your package and introduce you to, or organise pre-clinical studies in an
APAC location using our partners. We will provide full GLP compliant laboratory facilities.
� Clinical programme design utilising the sites and populations of APAC.
We have within our group, Phase I/2a capability in both healthy volunteers and special ethnic populations
applicable to the region (including those for Japanese registration) We also have an oncology Phase I Unit in
a well-equipped hospital with full laboratory and imaging facilities. Veeda Clinical Research provides a very
large clinical unit in Ahmedabad with bio-analytical capabilities. We also have clinical facilities in Malaysia
including both monitored Phase I facilities and Phase I Oncology. We have a special strength in glucose
clamping technologies and the advancement of biosimilar insulins.
� Full bio-analytical, special assay and Data management//Statistics across the region.
our bio-analytical tam is well known both for its small molecule and large molecule and immunogenicity. The
immunogenicity programme, will be dovetailed with the pharmacovigilance need.
� We have special understanding of the issues of biosimilars and vaccines and we will negotiate with the
various regulatory authorities on your behalf.
� If you have a drug development project which might benefit from the environment of the Asian region then
please approach, in the first instance contact the most convenient person listed below who will co-ordinate
a group of our experts tasked with making a preliminary analysis of your needs and will try and identify how
we can assist you.
Elizabeth Stevens [email protected] (SE Asia)
Yvonne Lungershausen; Yvonne [email protected] (Australia and New Zealand)
Preeti Makhijani: [email protected] (India)
