The 3rd Global Partner of Sambaepis is 'Sandos'... Selling Stelara Similar

New Partner Following Biogen and Oganon
'SB17' Selected as North America and Europe Sales Partner
Phase 3 Clinical Trial Results to Be Released Within the Year

Samsung Bioepis has chosen Sandoz as the overseas sales partner for 'SB17,' a biosimilar (biopharmaceutical generic) of the autoimmune disease treatment 'Stelara' (active ingredient ustekinumab) currently under development. While Samsung Bioepis's existing drugs have all been sold through Biogen or Organon, SB17 will be sold through a new partner this time.

Exterior view of Samsung Bioepis building in Songdo, Incheon [Photo by Samsung Bioepis]

On the 11th, Samsung Bioepis announced that it had signed a partnership agreement with Swiss pharmaceutical company Sandoz for the sales of SB17 in the North American and European markets. Sandoz is a generic and biosimilar specialist company newly established by Novartis, a global big pharma, by spinning off its generic and biosimilar business units.

SB17 is the fourth biosimilar developed in the autoimmune disease treatment category, following 'Enbrel' (product names Benepali and Brenzys), 'Remicade' (Renflexis and Flixabi), and SB5 (a Humira biosimilar). Previously, Biogen supplied the autoimmune disease treatments in Europe, while Organon handled supply in the U.S. and other regions, but this time, a new partner, Sandoz, has been appointed. A company official said, "We have established a cooperative system between companies leading the global biosimilar industry, which will expand prescription opportunities for patients," adding, "We expect to create synergy with a company possessing industry-leading expertise."

Park Sang-jin, Vice President and Head of Commercial Division at Samsung Bioepis, said, “This contract reaffirms Samsung Bioepis's capabilities accumulated in the autoimmune disease treatment market,” and added, “It will further solidify the value of expanding patient access to biosimilars.”

Janssen (a subsidiary of Johnson & Johnson)'s autoimmune disease treatment 'Stelara (active ingredient Ustekinumab)'

The original drug of SB17, Stelara, developed by Janssen (a subsidiary of Johnson & Johnson), is an interleukin (IL)-12 and 23 inhibitor and a representative blockbuster product in the autoimmune disease treatment field. According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market size reached $17.713 billion (approximately 23.5795 trillion KRW) last year.

SB17 completed its Phase 3 clinical trial in December last year and plans to present the results at related academic conferences within the year. Earlier, in March, results from a Phase 1 clinical trial confirming pharmacokinetic (PK) equivalence, safety, and immunogenicity through comparative studies with the original drug were disclosed at the American Academy of Dermatology (AAD) Annual Meeting.

Additionally, among domestic companies, Celltrion is developing 'CT-P43' and has applied for marketing authorization in Korea, the U.S., Europe, Canada, and Australia, while Dong-A ST is developing 'DMB-3115' and has applied for marketing authorization in Europe.

This content was produced with the assistance of AI translation services.