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 …

[HTML][HTML] Biosimilars in India; current status and future perspectives

BR Meher, S Balan, RR Mohanty… - Journal of Pharmacy …, 2019 - journals.lww.com
Many key biologics are scheduled to lose their patent by the year 2020, which will provide
the opportunity to other biopharmaceutical companies to develop the similar biologics …

[HTML][HTML] Quality, non-clinical and clinical considerations for biosimilar monoclonal antibody development: EU, WHO, USA, Canada, and BRICS-TM regulatory …

H Rahalkar, HC Cetintas, S Salek - Frontiers in Pharmacology, 2018 - frontiersin.org
Objective: The aim was to critically evaluate well-established regulatory agencies mAb
biosimilar guidelines for development and marketing authorization about quality, efficacy …

Biosimilars: a comparative study of regulatory, safety and pharmacovigilance monograph in the developed and developing economies

Z Iqbal, S Sadaf - Journal of Pharmacy & Pharmaceutical …, 2022 - journals.library.ualberta.ca
Epitomizing one of the rapidly maturing segments of pharmaceutical industry, biologics
gestalt has severely implicated treatment algorithms of many life-threatening diseases …

Economic perspective of cancer treatment in India

A Natarajan, N Mehra, T Rajkumar - Medical Oncology, 2020 - Springer
Financial constraints faced by the families play a vital role in cancer treatment refusal, non-
adherence, and failure of the prescribed therapy. This review aims to give an insight into the …

[PDF][PDF] Pharmaceutical research in India: current status and opportunities

M Sindkhedkar, S Jagtap, C Shah… - Proc Indian Natl Sci …, 2020 - researchgate.net
Pharmaceutical industry in India has made significant positive impact to health care
outcomes in India and other developing as well as developed countries. Indian pharma …

[HTML][HTML] An overview of biosimilars for cancer, diabetes mellitus, rheumatoid arthritis and other immune-mediated diseases approved between 2016 and 2021

S Priyarega, R Natarajan - Results in Chemistry, 2022 - Elsevier
The steep rise in the cost of brand name biologics and expiration of their patents led to the
arrival of several new biosimilars in the United States (US) and European Union (EU) …

Biosimilars: an approach to some current worldwide regulation frameworks

E Esteban, RH Bustos, JC García… - Current Clinical …, 2019 - ingentaconnect.com
Developing new biologics has led to regulations and norms aimed at guaranteeing their
safety, quality and effectiveness, in terms of marketing, prescription, use, interchangeability …

Mechanism of Biosimilars for the Treatment of Cancer

S Shilpi, E Gurnany, PK Gupta, K Sharma… - Biosimilars for Cancer …, 2024 - Springer
Biosimilars are biological medications that closely resemble FDA-approved biological
medications in terms of structure as well as functions and are approved according to the …

[HTML][HTML] Biosimilars in Retinal Diseases: A Primer

R Rawat, RK Saxena, M Agarwal - Delhi Journal of …, 2024 - journals.lww.com
Retinal disease management has witnessed remarkable advances with the development of
anti-VEGF molecules such as Lucentis®(ranibizumab), Eylea®(aflibercept), off-label …