New licensing, development and commercialisation agreement could expand Sandoz’s pipeline by to up to 32 assets.
Sandoz and Samsung Bioepis are collaborating to broaden access to high-quality biosimilar medicines globally, in a new deal that could advance up to five biosimilars.
The licensing and development agreement has potential to expand Sandoz’s pipeline by to up to 32 assets. The first biosimilar included in the deal is Samsung’s SB36, a vedolizumab biosimilar, currently in pre-clinical development. Its reference medicine is Entyvio, indicated for Crohn’s disease, ulcerative colitis or pouchitis.
Samsung Bioepis will develop the biosimilars and handle regulatory and manufacturing operations, while Sandoz will commercialise the medicines globally. This excludes China, Hong Kong, Taiwan, Macau, and Republic of Korea.
The news builds on Sandoz’s planned new global biosimilar development, manufacturing and supply unit, headed by Armin Metzger starting 1 April.
The collaboration could help the firm capitalise on the biosimilar loss-of-exclusivity market, estimated at around $320 billion over the next ten years.
[This partnership] is another important step toward capitalising on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis”
Richard Saynor, Chief Executive Officer, Sandoz, said: ”This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. It is another important step toward capitalising on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.”
Kyung-Ah Kim, President and Chief Executive Officer, Samsung Bioepis said: “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.”
Financial details of the transaction were undisclosed.
This month, the US Food and Drug Administration (FDA) made a key move to advance biosimilar regulation, with publication of new draft guidelines set to streamline unnecessary clinical pharmacokinetic (PK) testing.
Additionally, last October the FDA issued draft guidance proposing updated recommendations to reduce costs and timelines for biosimilar development.
