Biosimilars: Concepts and controversies

R Gámez-Belmonte, C Hernández-Chirlaque… - Pharmacological …, 2018 - Elsevier
Biosimilars are copies of reference biological drugs, developed as the patents for original
biologicals expire. They are thus developed to replicate an original biological medicine just …

Biosimilar drugs: concerns and opportunities

AA Genazzani, G Biggio, AP Caputi, M Del Tacca… - BioDrugs, 2007 - Springer
Patents for biologic agents first marketed in the 1980s are now beginning to expire, opening
the door for 'nonproprietary'versions of these agents to enter the market. However, there are …

From bioequivalence to biosimilarity: the rise of a novel regulatory framework

VD Karalis - Drug research, 2016 - thieme-connect.com
One of the most crucial issues in pharmacotherapy is to address the query if a patient can be
switched from one product to another of the same active substance. For the conventional …

Biosimilars: the paradox of sharing the same pharmacological action without full chemical identity

L Pani, S Montilla, G Pimpinella… - Expert opinion on …, 2013 - Taylor & Francis
The use of biotech medicines is increasing, with consequent mounting expenses for
National Health Systems (NHSs). Biosimilars should be considered an opportunity to …

An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare

F Mascarenhas-Melo, M Diaz, MBS Gonçalves… - Pharmaceuticals, 2024 - mdpi.com
Biological therapies have transformed high-burden treatments. As the patent and exclusivity
period for biological medicines draws to a close, there is a possibility for the development …

Biosimilars–terms of use

P Declerck, H Mellstedt, S Danese - Current Medical Research and …, 2015 - Taylor & Francis
The impending expiry of the patent on a number of leading biologic drugs has led to a surge
in the development of 'biosimilar'or 'follow-on'products. However, in contrast to generic small …

The language of biosimilars: clarification, definitions, and regulatory aspects

P Declerck, R Danesi, D Petersel, I Jacobs - Drugs, 2017 - Springer
Biologic therapies have revolutionized treatment of a number of diseases. Patents and
exclusivity for a number of biologics are expiring. This has created the opportunity for the …

Biosimilars: current status and future directions

SD Roger - Expert opinion on biological therapy, 2010 - Taylor & Francis
Importance of the field: Expiration of patents covering biopharmaceuticals, has provided
opportunities for pharmaceutical companies to develop, produce and market biosimilars or …

Biosimilars: an overview

BS Sekhon, V Saluja - Biosimilars, 2011 - Taylor & Francis
“Biologics”, considered one of the fastest growing sectors of the pharmaceutical industry,
has introduced many new treatments to life-threatening and rare illnesses. The first …

Biosimilar therapeutics—what do we need to consider?

H Schellekens - NDT plus, 2009 - academic.oup.com
Patents for the first generation of approved biopharmaceuticals have either expired or are
about to expire. Thus the market is opening for generic versions, referred to as …