PMID- 33231863
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20210730
IS  - 2168-4804 (Electronic)
IS  - 2168-4790 (Linking)
VI  - 55
IP  - 3
DP  - 2021 May
TI  - Biosimilars in Malaysia: Regulatory Framework, Approved Products, and Adverse 
      Effects.
PG  - 490-502
LID - 10.1007/s43441-020-00243-y [doi]
AB  - INTRODUCTION: Biosimilars are a cost-effective alternative to original biologic 
      medicines that allow patients access to biologic therapies for various chronic 
      diseases. Our paper aims to provide an overview of biosimilars in Malaysia with 
      emphasis on the comparison of Malaysian guidelines with guidelines from 
      well-established regulatory agencies, a review of biosimilars' market approval 
      and their reported adverse effects (AEs) as well as clinical trials conducted in 
      Malaysia. METHODS: We searched the official websites of the National 
      Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established 
      agencies, online databases of Medline(R) and EMBASE for guidelines on legislation 
      and regulations of biosimilars. Meanwhile, we extracted the reports of AEs 
      involving biosimilars in Malaysia from the NPRA database and for global AEs from 
      the World Health Organisation VigyLize database. The ClinicalTrials.gov Website 
      by the U.S. National Library of Medicines was the source for data on clinical 
      trials. RESULTS: Malaysia followed the principles of the European Medicines 
      Agency biosimilar regulations and issued their guideline in 2008. Since then, 
      NPRA has approved 24 biosimilar products and recorded 499 AE reports, of which 43 
      (8.6%) were serious. NPRA has also approved ten Phase III clinical trials in 
      Malaysia with four trials still ongoing. CONCLUSION: Malaysia follows a stringent 
      regulatory pathway for the approval of biosimilars enacted by well-established 
      regulatory agencies to maintain the quality, efficacy and safety of biosimilars. 
      Introducing biosimilars to the Malaysian market would improve patients' 
      accessibility to biologic therapies.
FAU - Mohd Sani, Noraisyah
AU  - Mohd Sani N
AD  - Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, 
      Malaysia.
AD  - National Pharmaceutical Regulatory Agency, Ministry of Health, Petaling Jaya, 
      Malaysia.
FAU - Aziz, Zoriah
AU  - Aziz Z
AUID- ORCID: 0000-0001-7113-9323
AD  - Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, 
      Malaysia. zoriah@um.edu.my.
AD  - Faculty of Pharmacy, MAHSA University, Bandar Saujana Putra, Jenjarom, Selangor, 
      Malaysia. zoriah@um.edu.my.
FAU - Kamarulzaman, Adeeba
AU  - Kamarulzaman A
AD  - Faculty of Medicine, University of Malaya, Lembah Pantai, 50603, Kuala Lumpur, 
      Malaysia.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20201124
PL  - Switzerland
TA  - Ther Innov Regul Sci
JT  - Therapeutic innovation & regulatory science
JID - 101597411
RN  - 0 (Biosimilar Pharmaceuticals)
SB  - IM
MH  - *Biosimilar Pharmaceuticals
MH  - Databases, Factual
MH  - Government Agencies
MH  - Humans
MH  - Malaysia
OTO - NOTNLM
OT  - Adverse effects
OT  - Biologic therapies
OT  - Clinical trials
OT  - Interchangeability
OT  - Regulatory guidelines
OT  - Substitutions
EDAT- 2020/11/25 06:00
MHDA- 2021/06/25 06:00
CRDT- 2020/11/24 12:13
PHST- 2020/09/06 00:00 [received]
PHST- 2020/11/10 00:00 [accepted]
PHST- 2020/11/25 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
PHST- 2020/11/24 12:13 [entrez]
AID - 10.1007/s43441-020-00243-y [pii]
AID - 10.1007/s43441-020-00243-y [doi]
PST - ppublish
SO  - Ther Innov Regul Sci. 2021 May;55(3):490-502. doi: 10.1007/s43441-020-00243-y. 
      Epub 2020 Nov 24.