Five early-stage biosimilar candidates from Samsung Bioepis will be marketed in various parts of the world by Sandoz, including SB36, for which Sandoz will hold marketing rights in the US.
Samsung Bioepis, which had earlier this year announced a substantial biosimilar infusion to its pipeline, entered into a marketing agreement on March 18th with Sandoz for at least one of its early-stage biosimilar candidates in the US.
The company specifically announced that its biosimilar for vedolizumab (SB36) will be marketed by Sandoz in the US and in most world markets, excluding Southeast Asia.
Vedolizumab Biosimilars and More in the US?
Beyond this Entyvio biosimilar candidate, Samsung did not suggest that Sandoz would be its US marketing partner for its other biosimilar targets, which include Keytruda, Taltz, Ocrevus, among others. However, Samsung Bioepis did state in its press release that the new agreement covers up to five biosimilar candidates (which may cover various global markets).
“We are very pleased to expand our successful partnership with Sandoz and to secure commercialization agreement for multiple biosimilar assets that are in early-stage development. The agreement is a significant progress in improving access to biologic medicines for patients living with debilitating conditions, who have limited access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer, Samsung Bioepis.
The Sandoz Biosimilar Pipeline Grows as Well
On the other hand, Sandoz has its own Keytruda biosimilar candidate (GME751), which suspended its late-stage clinical trial before the FDA’s announcement of its planned move away from requiring phase 3 trials. Sandoz also has its own Opdivo and Yervoy biosimilar candidates.
This arrangement fortifies Sandoz’s existing partnership with Samsung Bioepis, which already includes marketing agreements for the latter’s ustekinumab (Pyzchiva) and eculizumab (Epysqli) biosimilars. It adds to the roster of biosimilars in Sandoz’s pipeline as well.
Richard Saynor, Chief Executive Officer, Sandoz, stated in a press release, ”This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. It is another important step toward capitalizing on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.”
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.
