Biolojic Design Ltd. announced that Nektar Therapeutics Inc. has exercised its license option to develop a program resulting from the companies’ 2021 research collaboration, established to design and test agonistic antibodies targeting tumor necrosis factor receptor type II (TNFR2).
Researchers from Biohaven Pharmaceuticals Inc. presented preclinical data for the first-in-class extracellular bispecific IgG degrader, BHV-1300, being developed for the treatment of neuroinflammatory and autoimmune disease.
There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss.
Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23.
An oral Bruton’s tyrosine kinase (BTK) inhibitor that Sanofi SA acquired in 2020 through its $3.68 billion buyout of Principia Biopharma Inc. is headed toward regulatory filings in the U.S and EU by the end of the year, following phase III data in immune thrombocytopenia.
The generation of pathogenic autoantibodies is a crucial event in the development of inflammation and complement activation, leading to immune cell responses.
YS Biopharma Co. Ltd. has received clinical trial approval by the Philippine Food and Drug Administration to begin a phase I trial of its YS-HBV-002 immunotherapeutic vaccine, designed to treat chronic hepatitis B virus (HBV) infection. The trial will begin in the Philippines in June.
Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is now on a roll, with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one, Simlandi, as an adalimumab interchangeable.
The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.
With an IND filing in systemic lupus erythematosus expected during the third quarter of 2024, Cullinan Therapeutics Inc. changed its name from Cullinan Oncology Inc. and detailed its plans to target autoimmune diseases with CLN-978, a CD19xCD3 T-cell engager.
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