PMID- 31571620
OWN - NLM
STAT- MEDLINE
DCOM- 20200824
LR  - 20231014
IS  - 0972-2823 (Electronic)
IS  - 0022-3859 (Print)
IS  - 0022-3859 (Linking)
VI  - 65
IP  - 4
DP  - 2019 Oct-Dec
TI  - Pharmacovigilance of biosimilars - Why is it different from generics and 
      innovator biologics?
PG  - 227-232
LID - 10.4103/jpgm.JPGM_109_19 [doi]
AB  - Biosimilars are being marketed in India since 2000. Like biologics, biosimilars 
      have a large size, complex structure, and complicated manufacturing process, and 
      they are produced in a living organism. It requires specialized delivery devices 
      for administration and needs tighter temperature control to prevent degradation. 
      As biosimilar development follows abbreviated pathway, adverse events (AEs) 
      previously unknown during a clinical trial may be detected postmarketing. In 
      India, the awareness on pharmacovigilance has increased significantly after 
      implementation of the pharmacovigilance guidance in January 2018. However, 
      biologics require tighter monitoring to ensure their safety and efficacy. This 
      review article discusses the importance of pharmacovigilance for biosimilars, how 
      it is different from generics, and provides recommendations to sensitize 
      clinicians and researchers about the requirement of a different approach to 
      improve pharmacovigilance for biosimilars. Pharmacovigilance for biosimilars is 
      as important as it is for innovator biologics and more important than that for 
      generics.
FAU - Oza, B
AU  - Oza B
AD  - Clinical Development and Medical Affairs, Intas Pharmaceuticals Ltd. (Biopharma 
      Division), Ahmedabad, Gujarat, India.
FAU - Radhakrishna, S
AU  - Radhakrishna S
AD  - Clinical Development and Medical Affairs, Intas Pharmaceuticals Ltd. (Biopharma 
      Division), Ahmedabad, Gujarat, India.
FAU - Pipalava, P
AU  - Pipalava P
AD  - Clinical Development and Medical Affairs, Intas Pharmaceuticals Ltd. (Biopharma 
      Division), Ahmedabad, Gujarat, India.
FAU - Jose, V
AU  - Jose V
AD  - Clinical Development and Medical Affairs, Intas Pharmaceuticals Ltd. (Biopharma 
      Division), Ahmedabad, Gujarat, India.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - India
TA  - J Postgrad Med
JT  - Journal of postgraduate medicine
JID - 2985196R
RN  - 0 (Biological Products)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 0 (Drugs, Generic)
SB  - IM
CIN - J Postgrad Med. 2020 Apr-Jun;66(2):116. PMID: 32134006
MH  - Biological Products/*standards
MH  - Biosimilar Pharmaceuticals/*standards
MH  - *Drug Approval
MH  - Drugs, Generic/*standards
MH  - Humans
MH  - India
MH  - *Pharmacovigilance
PMC - PMC6813686
OTO - NOTNLM
OT  - Biosimilars
OT  - drug safety
OT  - lack of efficacy
OT  - pharmacovigilance
OT  - regulations
COIS- None
EDAT- 2019/10/02 06:00
MHDA- 2020/08/25 06:00
PMCR- 2019/10/01
CRDT- 2019/10/02 06:00
PHST- 2019/10/02 06:00 [pubmed]
PHST- 2020/08/25 06:00 [medline]
PHST- 2019/10/02 06:00 [entrez]
PHST- 2019/10/01 00:00 [pmc-release]
AID - 267890 [pii]
AID - JPGM-65-227 [pii]
AID - 10.4103/jpgm.JPGM_109_19 [doi]
PST - ppublish
SO  - J Postgrad Med. 2019 Oct-Dec;65(4):227-232. doi: 10.4103/jpgm.JPGM_109_19.