The concept of biosimilars: from characterization to evolutiona narrative review

F Farhat, A Torres, W Park, G de Lima Lopes… - The …, 2018 - academic.oup.com
… We aim to clarify the concept of biosimilar, from … a literature search on the sites of the
medicines regulatory agencies and PubMed from 1990 to 2014 with the keywords “biosimilars,” “…

Biosimilars: an update

S Bhojaraj, TDA Kumar, AR Ghosh… - … Journal of Nutrition …, 2021 - journals.lww.com
… efficacy and safety data on biosimilars. This review summarizes the recent updates on
biosimilars, synthesis, characterization, and current market status. Brief information on the role of …

Clinical and regulatory concerns of biosimilars: a review of literature

V Halimi, A Daci, K Ancevska Netkovska… - International journal of …, 2020 - mdpi.com
… To conduct and explore this review, we mainly followed the PRISMA guidelines for systematic
reviews [18], although “state of the art” methodology was also used. To identify relevant …

[PDF][PDF] Clinical and Regulatory Concerns of Biosimilars: A Review of Literature

A Grozdanova, H Vesa, A Daci… - Int. J. Environ. Res …, 2020 - repository.ukim.mk
… explore this review, we mainly followed the PRISMA guidelines for systematic reviews [18], …
Preferred reporting items for systematic review and meta-analysis protocols (prisma-p) 2015…

Adalimumab biosimilars in the treatment of rheumatoid arthritis: a systematic review of the evidence for biosimilarity

TWJ Huizinga, Y Torii, R Muniz - Rheumatology and therapy, 2021 - Springer
… efficacy and safety can clearly be deduced from the similarity of physicochemical
characteristics, biological activity/potency, and PK and/or PD profiles of the biosimilar and the RP. …

[PDF][PDF] The complexities of biosimilars and the regulatory approval process

S Lucio - Am J Manag Care, 2018 - ajmc.s3.amazonaws.com
… The designation of biosimilars is defined in relation to a reference product in an FDA
licensure … The concept of biosimilars: from characterization to evolutiona narrative review. …

Assessment of the differences between generic and biosimilar drugs: a brief literature review

R Sayah, S Awada, L Ismaiil… - Journal of Generic …, 2023 - journals.sagepub.com
… Even though generic drugs and biosimilars are both copies of a reference drug, they differ
… , this short review aims to compare generic drugs and biosimilars in terms of characteristics, …

Global acceptance of biosimilars: importance of regulatory consistency, education, and trust

E Cazap, I Jacobs, A McBride, R Popovian… - The …, 2018 - academic.oup.com
… or summaries of product characteristics (SmPCs). In Europe, … systematic review of assessment
reports for biosimilars … and that, even for biosimilars referencing the same originator, there …

[DOC][DOC] Literature Review of International Biosimilar Medicines: Update December 2017–February 2018

M Ward, SR Lange, K Staff, P MPharm - health.gov.au
… during the review period that are of a technical nature and relate to topics such as the
physicochemical and pharmacological characterisation of potential biosimilar medicines. …

A bibliometric analysis of the global research on biosimilars

A Hernández-Vásquez, CA Alarcon-Ruiz… - … policy and practice, 2018 - Taylor & Francis
Biosimilars could be a promising option to help decrease healthcare costs and … analysis
on biosimilars. Therefore, we aimed to assess the quantity and quality of worldwide biosimilars