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Der Pharmacia Sinica
ISSN: 0976-8688
Eurosc i con Conference on
Medicinal Chemistry
and Biosimilars
M a r c h 2 5 - 2 6 , 2 0 1 9
B u d a p e s t , H u n g a r y
Medicinal Chemistry & Biosimilars 2019
W
ith over 100 products currently available as potential biosimilar candidates, there is a dire need to develop a dossier that
will be acceptable globally, if we are to make biosimilars accessible, available and affordable. Generally, if a product is
approvable in US, the barrier to EU entry is lowered significantly, not the other way. I have filed citizen petitions to FDA to change
its evaluation process to bring the EU and US requirements closer; this advise includes removing bridging studies, modifying the
analytical similarity testing because of mistakes in the guideline, which the FDA withdrew after receiving my petition; change the
PK testing protocols; adopt more
in vitro
immunogenicity testing and minimize in-patient studies. A few years ago, EMA would not
consider any filing without testing in patients, now they do, just like the FDA does. Similar to how the International Conference on
Harmonization (ICH), there is a dire need to develop global guidelines that will be acceptable to all development countries. I am
presenting an outline of this guideline, as I have submitted to FDA and EMA for consideration.
niazi@niazi.comGlobalization of biosimilars
Sarfaraz K Niazi
1, 2
1
University of Illinois, USA
2
Karyo Biologics and PharmSci, USA
Der Pharmacia Sinica 2019, Volume:10
DOI: 10.21767/0976-8688-C1-003