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SomaLogic announces it has signed an agreement with the FDA for the large-scale analysis of proteins for the identification of biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar and a reference product. It is hoped that the five year colla...

SomaLogic announced it has signed an agreement with the FDA for the large-scale analysis of proteins for the identification of biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar and a reference product. It is hoped that the five year colla...

In its Q3 2020 financial results, Amgen announces that it is moving ABP 654 (proposed ustekinumab biosimilar) into Ph III development.

Alvotech announces that its parent company, Alvotech Holdings SA, has successfully completed a $65 million private placement round, which will further finance the development and release of its biosimilar candidates. This $65 million round is part of a larger $100 million r...

Alvotech announced that its parent company, Alvotech Holdings SA, has successfully completed a $65 million private placement round, which will further finance the development and release of its biosimilar candidates. This $65 million round is part of a larger $100 million r...

Samsung Bioepis announces results from two post-marketing studies of Renflexis® (biosimilar infliximab) in Veteran Affairs patients with IBD. The first study evaluated the safety of switching from reference infliximab to Renflexis®, finding that patients who were on referen...

Significant biosimilar activities this week include
15 Oct 20 | Henlius and Essex announced they have entered into a co-development and exclusive license agreement for HLX04 (proposed bevacizumab biosimilar). Under the agreement, Essex will be granted an exclusive lic...

Industry Minister Karen Andrews announced it could take up to 12 months to roll out a COVID-19 vaccine, if the successful candidate is not protein-based. Andrews explained that while CSL has a lot of experience in producing protein-based vaccines, mRNA vaccines have never b...

AstraZeneca announced it has resumed clinical trials in the US following authorisation from the FDA. The trials have now fully resumed globally.

Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commence recruiting in Poland.