Samsung Bioepis, Teva Partner on Two Niche Biosimilars; Key Terms, Including Upfront Payment, Undisclosed

Samsung Bioepis has signed a development and commercialization agreement with global pharmaceutical company Teva for two biosimilars targeting severe eosinophilic asthma and rare autoinflammatory diseases.

Samsung Epis Holdings said in a disclosure on the 1st that its subsidiary Samsung Bioepis had entered into an early collaboration agreement with Teva Pharmaceutical International for the research and development and commercialization of biosimilars SB41 and SB44. The agreement was signed on the 30th of last month.

Under the agreement, Samsung Bioepis will handle product development, regulatory approvals and the manufacture and supply of finished drugs for the two candidates. Teva will have exclusive distribution and sales responsibilities in major markets in North America and Europe, including the United States, Europe and Canada.

The agreement also includes the option to expand sales territories in the future and partnership options for up to four additional follow-on biosimilars held by Samsung Bioepis.

However, key terms, including the upfront payment, milestone payments, profit-sharing ratio and contract term, were withheld on the grounds of business confidentiality. The disclosure deferral period runs through May 31, 2042. The only confirmed minimum threshold is that the agreement is worth at least about 41.8 billion won, or 2.5% of Samsung Bioepis' 2025 consolidated revenue of 1.6719 trillion won.

The reference products for the two candidates are AstraZeneca's Fasenra (ingredient: benralizumab) and Novartis' Ilaris (ingredient: canakinumab). Fasenra recorded global sales of about $1.981 billion (about 2.9 trillion won) in 2025, while Ilaris recorded about $1.883 billion (about 2.7 trillion won).

With these two additions, Samsung Bioepis has expanded its follow-on pipeline to a total of nine candidates. The company emphasized that it had secured a new source of commercial growth in immunology and rare diseases.

Some in the pharmaceutical industry are taking a cautious view of the agreement. They say Fasenra and Ilaris are closer to niche products with limited market potential when compared with megablockbusters such as Keytruda, which generates more than $30 billion in annual sales.

Ilaris, in particular, targets multiple ultra-rare diseases, leaving a very small patient population. There are concerns that biosimilar launches will inevitably trigger price competition, with discounts of 30% to 50% or more from the reference drug's price, and that actual net sales could plunge after rebates and distribution fees are deducted.

Patent barriers are also cited as a risk. Fasenra's key U.S. patents are understood to expire around 2030, leaving several years before commercial launch. Although many Ilaris patents have expired or are nearing expiration, patent disputes could arise as companies seek to work around Novartis' defensive patent portfolio.

The agreement is described as a conditional arrangement at an early stage and may be terminated early if regulators require additional clinical work or if marketing approval is not obtained.

Samsung Bioepis' heavy reliance on Teva is another point of concern. Samsung Bioepis previously entrusted Teva with U.S. rights to Epysqli and Canadian rights to Opuviz, and has now handed over the two immunology products as well. Rather than diversifying partnerships, the company appears to be concentrating its distribution channels with a single partner, Teva.

When rights are fully outsourced, manufacturers have little choice but to accept limited influence in negotiations over local formulary listings and pricing policies. Analysts say the company is exposed to “single-partner risk,” in which the entire partnership could be destabilized if Teva faces worsening profitability or changes its business strategy.

The fact that all key indicators for assessing actual profitability, including the upfront payment, milestone payment terms and royalty rate, remain undisclosed is also fueling investor fatigue. The disclosure deferral period, which runs until 2042—16 years from now—makes it difficult even to assess the company's economic benefits after the fact.

The additional partnership options for up to four follow-on pipeline candidates are merely rights whose exercise will depend on future market conditions. If they do not convert into definitive agreements, plans for further collaboration could amount to nonbinding declarations.

Ultimately, the partnership leaves commercialization challenges unresolved despite the stated rationale of portfolio diversification. The strategy can be interpreted as an effort to avoid cutthroat competition by choosing small- and midsize niche markets instead of large blockbuster markets, but the absolute market size is small, which necessarily limits potential returns.

In the long term, success is expected to depend on how quickly the company completes clinical development while overcoming the structural constraint of sharing distribution margins with Teva. The market is closely scrutinizing the uncertainty and actual economics behind the high-profile partnership announcement.