Teva, Samsung Bioepis deepen bonds in pact for up to 6 new biosimilars

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The pact will see Samsung Bioepis take charge of development, regulatory work and manufacturing on the biosimilar candidates, while Teva is on deck for commercialization duties should they win approval.

Already sharing the load on two biosimilar assets, Teva Pharmaceutical and Samsung Bioepis have elected to take their partnership to the next level. 

This week, the companies unveiled an expanded deal to develop and commercialize up to six potential biosimilar candidates—copycats of off-patent biologic drugs that fill the same niche as small-molecule generics—including two that will reference AstraZeneca’s immunology stalwart Fasenra and Novartis’ Ilaris, cleared in periodic fever syndromes and Still’s disease, among other indications. 

The pact will see Samsung Bioepis take charge of development, regulatory work and manufacturing, while Teva is on deck for commercialization duties around the world—including the U.S., Europe and Canada—if the biosimilars pass muster with regulators, the companies said in a release. 

The companies added that they’ve “agreed to an option for expanding the partnership to other territories,” too. 

Teva, already well known for its generics and biosimilar bona fides, linked up with South Korea’s Samsung Bioepis last January in a similar agreement focused on Epysqli, a biosimilar developed by Samsung that references AZ’s Soliris in the U.S. 

Subsequently, the partners over the summer struck up a licensing and commercialization accord for the Eylea biosimilar Opuviz in Canada. 

Teva and Samsung Bioepis cited their previous tie-ups as motivation for the latest deal, homing in specifically on the success of their work on Epysqli in the U.S. 

“Biosimilars are an increasingly important part of our Pivot to Growth strategy and our ambition to transform into a leading biopharmaceutical company,” said Richard Francis, Teva’s CEO, in a statement. “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 U.S.”

The partners did not divulge details around the other biosimilar targets. Financial details of the pact were not disclosed either. 

The companies’ refreshed agreement follows a string of other high-ambition biosimilar announcements in 2026, as specialists in the field have looked to capitalize on a massive approaching patent cliff for many of the industry’s lucrative branded drugs. 

That reality goes part and parcel with the concept of the ‘biosimilar void,’ which refers to a dearth of in-development biologic copycats for many drugs facing exclusivity losses in the late 2020s and early 2030s. In turn, that development gap both poses threats to access to more affordable biosimilars, plus tremendous opportunities for companies that can seize on the open playing field. 

Samsung Bioepis, for its part, lined up an agreement with another of the industry’s big players, Sandoz, back in March, to partner on up to five biosimilars. The first asset on the docket for that deal is SB36, which references Takeda’s Entyvio and is in development by Samsung. 

Meanwhile, Sandoz itself set an ambitious goal early last month to establish a portfolio of more than 100 biosimilars by 2040, up from the 13 it currently markets. At an investor event in September, Sandoz leadership pointed to that same wave of heavy patent losses approaching, noting that a “golden decade” for its own business could exist on the other side of that cliff.