Biosimilar

Dec 01, 2023

The FDA recently approved Amgen’s Wezlana (ustekinumab-auub) for various inflammatory conditions, marking the first biosimilar approval referencing the popular J&J drug Stelara (ustekinumab). Wezlana, mirroring its reference product, is approved for treating multiple inflammatory diseases in adults, including m...

Dec 15, 2021

Since the first biosimilar drug was approved in 2006, the EU has led the way in biosimilar regulation. Over the last decade, the EU has authorized the most biosimilars globally, gathering significant expertise with their usage and safety. Over ten years of clinical experience has shown that biosimilars licensed by ...

Nov 22, 2019

Biologics are not new drugs, their use as a medicine has been around for over a century. The first use of Biologic drug dates back to the year 1796 when the vaccine to treat smallpox was created.They have been revolutionizing the treatment approaches for the past many years. Hormones, insulin, blood products, cytok...

Mar 12, 2019

Stemline gives in-licenses global rights to SL-1001 Stemline Therapeutics, Inc. is a biopharmaceutical company focused on development and commercialization of novel oncology therapeutics, has licensed worldwide rights to a preclinical molecule RET (rearranged during transfection) kinase inhibitor. The RET kinase...

Sep 18, 2018

A biosimilar (copycat version) is a pharmaceutical product that is close, but not identical, copy of an approved biologic branded product. It is known as a biosimilar, rather than a biogeneric, because current technology does not approve of making an exact copy of a large molecule drug and the sky reaching cost of p...

Nov 21, 2017

EMA to relocate to Amsterdam by March 2019 Results of the Monday's vote for the European Medicines Agency relocation led to the emergence of Amsterdam as the new headquarters, beating the other finalists Milan and Copenhagen. Nineteen European Union member states submitted proposals for the EMA headquarters, and Mil...

Jan 13, 2017

The high cost of pharmaceuticals, especially Biologics, has been proven as an issue in the battle to control healthcare costs. The Biologics Price Competition and the Innovation Act has put forward the generic competition of Biologics or what is popularly called the Biosimilars. Biosimilars have been available in th...

Oct 28, 2016

Today's opportunity for Indian companies in biosimilars is not much different from that of the generics industry in 1984. According to Ministry of Commerce and Industry, India’s pharmaceutical export segment has more than doubled from $ 7.8 billion in 2008 to $ 16.5 billion in 2014. With biologic treatments int...

Aug 19, 2016

Zymeworks licenses new drug discovery platform from Innovative Targeting Solutions Zymeworks, a biotech company working on bispecific antibodies, has signed a licensing deal with Innovative Targeting Solutions (ITS) for HuTARG, which works as a protein engineering platform, and is the first fully mammalian tech that...