Progress in biopharmaceutical development

M Kesik‐Brodacka - Biotechnology and applied biochemistry, 2018 - Wiley Online Library
Since its introduction in 1982, biopharmaceutical drugs have revolutionized the treatment of
a broad spectrum of diseases and are increasingly used in nearly all branches of medicine …

Biosimilars: key regulatory considerations and similarity assessment tools

CF Kirchhoff, XZM Wang, HD Conlon… - Biotechnology and …, 2017 - Wiley Online Library
A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance
document as a biopharmaceutical that is highly similar to an already licensed biologic …

The breakthrough of biosimilars: a twist in the narrative of biological therapy

ER Kabir, SS Moreino, MK Sharif Siam - Biomolecules, 2019 - mdpi.com
The coming wave of patent expiries of first generation commercialized biotherapeutical
drugs has seen the global market open its doors to close copies of these products. These …

Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab

BG Feagan, G Lam, C Ma… - Alimentary …, 2019 - Wiley Online Library
Background Biosimilar versions of widely prescribed drugs, including the tumour‐necrosis
factor antagonist infliximab, are becoming increasingly available. As biosimilars are not …

Physicochemical characterization of biopharmaceuticals

MK Parr, O Montacir, H Montacir - Journal of pharmaceutical and …, 2016 - Elsevier
Biopharmaceuticals are gaining interest in therapy due to their high target selectivity. Most of
the recently approved biopharmaceuticals represent drugs that are produced by …

Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective

A Sharma, N Kumar, BD Kuppermann… - British Journal of …, 2020 - bjo.bmj.com
Purpose This article aims to analyse the key regulatory guidelines across the globe
concerning biosimilars. Materials and methods Review of the current literature. Results …

Monoclonal antibody and fusion protein biosimilars across therapeutic areas: a systematic review of published evidence

I Jacobs, D Petersel, LG Shane, CK Ng, C Kirchhoff… - BioDrugs, 2016 - Springer
Background Despite regulatory efforts to formalize guidance policies on biosimilars, there
remains a need to educate healthcare stakeholders on the acknowledged definition of …

[HTML][HTML] The biosimilars journey: current status and ongoing challenges

IA Kos, VF Azevedo, DE Neto, SC Kowalski - Drugs in context, 2018 - ncbi.nlm.nih.gov
Biosimilar products are already approved and marketed in several countries. The Food and
Drug Administration has approved ten different biosimilars, and the European Medicines …

Waiving in vivo studies for monoclonal antibody biosimilar development: national and global challenges

K Chapman, A Adjei, P Baldrick, A da Silva, K De Smet… - MAbs, 2016 - Taylor & Francis
Biosimilars are biological medicinal products that contain a version of the active substance
of an already authorised original biological medicinal product (the innovator or reference …

Similar or the Same? Why Biosimilars are not the Solution

L Diependaele, J Cockbain, S Sterckx - Journal of Law, Medicine & …, 2018 - cambridge.org
Advancements in the field of biotechnology have accelerated the development of drugs that
are manufactured from cultures of living cells, commonly referred to as “biologics.” Due to …