On October 1, Samsung Bioepis and Teva announced that they will be partners in bringing up to 6 more biosimilars to the North American and European markets.
The October 1 press release by Samsung Bioepis and Teva was a further statement of shared biosimilar interests: They are extending their existing partnership to include what may be two biosimilars that have been publicly announced as targets, as well as an option for 4 more biosimilar candidates.
For the two specific biosimilar candidates covered by the announcement—Fasenra (benralizumab)andIlaris (canakinumab)— Samsung will be responsible for development, regulatory processes, and manufacturing, and Teva will commercialize the products. The biosimilar candidate for benralizumab is designated SB41; the reference product is a maintenance treatment for patients with severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, and hypereosinophil syndrome. The Ilaris biosimilar candidate is designated SB44; Ilaris is an interleukin-1 beta agent approved for the treatment of Still’s disease, gout flares, and periodic fever syndromes.
Samsung Bioepis and Teva have already teamed up on the FDA-approved eculizumab biosimilar Epysqli. “We are thrilled to expand our successful partnership with Teva with these new biosimilar candidates. This agreement marks another milestone in our shared journey to improve patient access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer at Samsung Bioepis.
Richard Francis, President and CEO of Teva said, “Biosimilars are an increasingly important part of our Pivot to Growth strategy and our ambition to transform into a leading biopharmaceutical company. This global multi-product agreement is a significant step in scaling our biosimilars business, adding greater breadth to our pipeline and building on the strong foundation we have established with Samsung Bioepis in the US.”
In addition to Teva, Samsung Bioepis had signed agreements with several marketers, including Organon (selling Renflexis, for example), Sandoz (for Pyzchiva and up to 5 biosimilar candidates), and Harrow (for Opuviz and Byooviz),
This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.
