In June 2021, Malaysian oncology generics company, Oncogen, and China’s BrightGene Bio-Medical Technology announced that they are partnering to develop, manufacture, market and distribute generic drug products for the US market.
Oncogen–BrightGene partnership
Home/Pharma News | Posted 10/09/2021 0 Post your comment
Under the terms of their agreement, the companies plan to leverage expertise, to create highly efficient and effective product flow. Initially, they will focus on a generic oncology product which has been developed, but further collaboration will include all aspects of drug development from active pharmaceutical ingredients (APIs) manufacturing through to regulatory approval and distribution.
Oncogen will primarily focus on product development, filing the abbreviated new drug applications (ANDAs) for US Food and Drug Administration approval and the commercial launch of the products in the US market. Manufacturing will be carried out at their facility in Malaysia and products should be ready for initial shipments by the middle of 2022
BrightGene recently announced their successful production of remdesivir, an experimental treatment for coronavirus, however, patents for the drug are currently held by the American company Gilead [1].
Related article
Further collaborations formed to penetrate China’s generics market
LATIN AMERICAN FORUM The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View this week’s headline article: Conocimiento y percepciones de la denominación de biosimilares en EE. UU. Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de esta semana: Conocimiento y percepciones de la denominación de biosimilares en EE. UU. Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. |
Reference
1. GaBI Online - Generics and Biosimilars Initiative. Chinese company makes copy of patented coronavirus treatment remdesivir [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 10]. Available from: www.gabionline.net/generics/news/Chinese-company-makes-copy-of-patented-coronavirus-treatment-remdesivir
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.
Guidelines
Regulatory update for post-registration of biological products in Brazil
New regulations in Brazil for the registration of biosimilars
Policies & Legislation
NPRA Malaysia trials new timelines for variation applications
Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
Meitheal expands portfolio with three biosimilars through exclusive US licensing agreement
EMS proposes merger with Hypera to form Brazil's largest drugmaker
Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206
Advances for Biocon Biologics’ Stelara and Eylea biosimilars
Comments (0)
Post your comment