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O c t o b e r 1 5 - 1 6 , 2 0 1 8 | T o k y o , J a p a n
Obesity Congress 2018, Diabetes Congress 2018 & Vaccines Congress 2018
Note:
Page 33
Biomedical Research | ISSN: 0976-1683| Volume 29
2nd WORLD OBESITY CONGRESS
2nd WORLD VACCINES AND IMMUNOLOGY CONGRESS
&
&
DIABETES AND ENDOCRINOLOGY
International Conference on
Joint Event on
OF EXCELLENCE
IN INTERNATIONAL
MEETINGS
YEARS
Agam Shah, Biomed Res 2018, Volume 29 | DOI: 10.4066/biomedicalresearch-C5-012
PRE-CLINICAL & CLINICAL
DEVELOPMENT OF BIOSIMILAR
INSULINS/INSULIN ANALOGUES: THE
CLINICAL IMPLICATIONS OF CRITERIA
FOR SIMILARITY
Introduction: Akin to generic product development through pharmaceutical
equivalence followed by bioequivalence compared to reference medicinal
product to ascertain similar safety and efficacy, biosimilar insulin/analogue
product (BIP) development includes physio-chemical-biological characteriza-
tion followed by human PK-PD study and safety-efficacy-immunogenicity study
compared to reference insulin product (RIP) to ascertain the same. Although,
development of multiple biosimilar insulin products has been undertaken
throughout the world, clarity about the clinical implications of the results of
these studies is not much discussed.
Objective: To assess the clinical implications of pre-clinical and clinical studies
undertaken on BIP to establish its similarity to their RIP in terms of their results.
Methods: Results of studies conducted by Wockhardt Ltd. for development of
their BIP of insulin glargine as per in comparison to RIP were evaluated to as-
sess their criteria for similarity in the context of clinical implications.
Results: Results of the in vitro receptor binding assays, in vitro receptor au-
to-phosphorylation, in vitro metabolic assays and in vivo PD studies indicate
that BIP is comparable to the RIP in the potential for glucose lowering effects.
Whereas, results of the in vitro mutagenicity assays, sub-chronic toxicity study
indicate that BIP is comparable to the RIP in potential for toxicities, pharma-
cokinetics and immunogenicity. Results of human PK-PD studies conducted
in healthy volunteer and type 1 diabetics under euglycemic clamp settings
proved that BIP is bioequivalent to the RIP in glucose lowering effect and insu-
lin glargine exposure. Whereas, results of comparative safety-efficacy-immu-
nogenicity studies in type 1 and type 2 diabetics confirmed that BIP is non-in-
ferior to RIP in glycaemic control as well as comparable to it in hypoglycaemic
events, other adverse events and immunogenicity.
Conclusion: Pre-clinical and clinical development data on BIP offers compre-
hensive information of clinical PK-PD, safety, efficacy and immunogenicity in
comparison to RIP to understand clinical implications of BIP’s use in practice.
Biography
Agam Shah has rich professional experience of nearly
15 years in clinical development, medical affairs and
academics. He has been an avid Clinical Research
Physician with numerous scientific publication and
presentations to his name. He has comprehensive ex-
perience of clinical development of biosimilars, com-
plex generics and vaccine products.
Agam Shah
Wockhardt Ltd, India