PMID- 35968654
OWN - NLM
STAT- MEDLINE
DCOM- 20221021
LR  - 20221201
IS  - 1744-7682 (Electronic)
IS  - 1471-2598 (Linking)
VI  - 22
IP  - 10
DP  - 2022 Oct
TI  - A review of bridging clinical studies between different presentations of 
      biological products approved by the United States Food and Drug Administration 
      (US FDA).
PG  - 1293-1310
LID - 10.1080/14712598.2022.2113053 [doi]
AB  - INTRODUCTION: There is growing interest in the development of multiple 
      presentations for biological products for subcutaneous (SC) injection for life 
      cycle management and product differentiation. Bridging clinical studies are 
      required to extrapolate the existing data package to new presentations. AREAS 
      COVERED: This review compiles information of bridging clinical studies conducted 
      for biological products administered by the SC route and approved in more than 
      one presentation by the United States Food and Drug Administration's Center for 
      Drug Evaluation and Research up until 31 December 2021. Information regarding 
      indication(s), presentation(s), approval pathways, approval timelines, and 
      various aspects of bridging clinical studies was collected from published 
      documents. EXPERT OPINION: The type of bridging clinical study can depend on the 
      extent of differences between presentations, existing data packages, and the 
      stage of the product development. Design of a bridging clinical study should be 
      based on the characteristics of a biological product and should be aimed at 
      detecting the relevant differences between presentations. Single-dose comparative 
      pharmacokinetics in normal healthy volunteers is the most common bridging 
      clinical study design. Covariates like body weight and injection site should be 
      considered during the design of these studies. The impact of the different user 
      interfaces of presentations should also be considered.
FAU - Patel, Ronak
AU  - Patel R
AD  - Research and Development, Intas Pharmaceuticals Limited (Biopharma Division), 
      Ahmedabad, India.
FAU - Ghadge, Pravin
AU  - Ghadge P
AD  - Commercial Development, Intas Pharmaceuticals Limited, Corporate House, 
      Ahmedabad, India.
FAU - Nair, Pravin A
AU  - Nair PA
AD  - Research and Development, Intas Pharmaceuticals Limited (Biopharma Division), 
      Ahmedabad, India.
FAU - Kumar, Manish
AU  - Kumar M
AD  - Research and Development, Intas Pharmaceuticals Limited (Biopharma Division), 
      Ahmedabad, India.
FAU - Adhikary, Laxmi
AU  - Adhikary L
AD  - Research and Development, Intas Pharmaceuticals Limited (Biopharma Division), 
      Ahmedabad, India.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20220818
PL  - England
TA  - Expert Opin Biol Ther
JT  - Expert opinion on biological therapy
JID - 101125414
RN  - 0 (Biological Products)
RN  - 0 (Pharmaceutical Preparations)
SB  - IM
MH  - United States
MH  - Humans
MH  - United States Food and Drug Administration
MH  - *Drug Approval
MH  - *Biological Products/adverse effects
MH  - Pharmaceutical Preparations
OTO - NOTNLM
OT  - Bioequivalence
OT  - biological product
OT  - bridging
OT  - clinical
OT  - pharmacokinetic
OT  - presentation
EDAT- 2022/08/16 06:00
MHDA- 2022/10/22 06:00
CRDT- 2022/08/15 04:42
PHST- 2022/08/16 06:00 [pubmed]
PHST- 2022/10/22 06:00 [medline]
PHST- 2022/08/15 04:42 [entrez]
AID - 10.1080/14712598.2022.2113053 [doi]
PST - ppublish
SO  - Expert Opin Biol Ther. 2022 Oct;22(10):1293-1310. doi: 
      10.1080/14712598.2022.2113053. Epub 2022 Aug 18.