The US biosimilars market gained a notable partnership on 3 November 2026, when Teva agreed to commercialise two Samsung Bioepis products in the United States: ETICOVO (etanercept-ykro), a biosimilar to Enbrel, and infliximab-abda, a biosimilar to Remicade. The FDA approved the products in 2019 and 2017, so this is a commercial deal and not a regulatory milestone. The economics are largely undisclosed, which limits what can be said about its value.
Key takeaways on the US biosimilars market deal
- Teva takes US commercialisation of two TNF inhibitor biosimilars; Samsung Bioepis keeps regulatory and manufacturing roles.
- Rights move in stages: ETICOVO at closing (expected by end-2026) and infliximab-abda in Q3 2027.
- Terms: an upfront payment over three years, possible launch and sales milestones, and a profit share. No amounts were disclosed.
- ETICOVO is not currently sold in the US, and its launch timing will be announced later.
- Closing is subject to customary conditions, including regulatory approvals.
Deal structure at a glance
| Element | Detail |
|---|---|
| Products | ETICOVO (etanercept-ykro), infliximab-abda |
| Reference medicines | Enbrel and Remicade |
| FDA approvals | 2019 and 2017 respectively |
| Teva role | US commercialisation |
| Samsung Bioepis role | Regulatory matters and manufacturing |
| Payment | Upfront over three years, milestones, profit share; amounts not disclosed |
| Rights transfer | End-2026 at closing (ETICOVO); Q3 2027 (infliximab-abda) |
Why a staggered transfer matters
The two-step timeline is a practical feature of the deal. ETICOVO has no current US sales, so it can pass to Teva at closing and launch when Teva is ready, with timing to be announced. Infliximab-abda is an established product, and the Q3 2027 date suggests an orderly handover, although the release does not say why that date was chosen or who sells the product today. We view the gap as a sign that existing arrangements are being respected, but this is our inference, not a stated reason.
What Teva gains and what Samsung Bioepis keeps
For Teva, the appeal is a larger biosimilar portfolio built from products that are already approved, so no further US approval is needed to sell them. Executives at both companies, including Teva CEO Richard Francis and Samsung Bioepis CEO Kyung-Ah Kim, are quoted in the release. For Samsung Bioepis, the arrangement keeps development and manufacturing in-house while a partner handles US selling. The release does not provide sales projections for either party.
The partnership is also part of a pattern. EPYSQLI (eculizumab-aagh) reached the US market in 2025 under a Teva collaboration, an aflibercept biosimilar called OPUVIZ is part of a Canadian agreement in 2026, and a global agreement covers up to six early-stage candidates. For Teva’s wider financial picture, see our report on its third-quarter 2026 results and the pharmaceuticals section.
Timeline
- 2017: infliximab-abda approved by the FDA.
- 2019: ETICOVO approved by the FDA.
- 2025: EPYSQLI US collaboration.
- 2026: OPUVIZ in Canada and a global early-stage deal.
- 3 November 2026: US agreement on the two TNF biosimilars.
- End-2026 and Q3 2027: expected rights transfers.
Competitive implications (our framing)
The TNF inhibitor class is mature, with reference products and multiple biosimilars already in the market. We have not been given data on shares, prices or rebates, so any view on competition is general. The usual commercial levers in this class are contracting with payers and pharmacy benefit managers, pricing relative to the reference product, and supply reliability. Whether Teva can make ETICOVO a meaningful player depends on those factors, on which the companies are silent.
Market context: biosimilars
According to Acumen Research And Consulting, the global biosimilars market was valued at USD 26.7 billion in 2023 and is projected to reach USD 113.2 billion by 2032, a compound annual growth rate of 17.5% over 2024 to 2032. North America accounted for about USD 10.7 billion, Asia-Pacific is expected to grow at over 18.4% and recombinant non-glycosylated proteins were the largest product group at over USD 14.4 billion.
The Acumen page is dated August 2017 despite using a 2023 base year, and it has a stray heading from another market, so we treat it as an indicative estimate. By our own arithmetic, North America’s USD 10.7 billion is roughly 40% of the USD 26.7 billion global figure. The report is global and does not isolate US sales or these two products.
Our analysis
In our assessment, the deal adds optionality for Teva more than a near-term step-change. ETICOVO could add a new US product, but its launch date and pricing are open, and infliximab-abda arrives only in the second half of 2027. Samsung Bioepis, meanwhile, gains a seller without ceding the manufacturing role. Without numbers on the upfront payment or profit share, we cannot assess the financial significance, and we make no forecast of revenue or share price.
What is not disclosed
- Upfront payment, milestones and profit-share percentage.
- ETICOVO launch date and pricing.
- Current US marketer and brand name for infliximab-abda.
- Revenue expectations for either product.
- Status of regulatory approvals required to close.
Risks and caveats
- Closing depends on customary conditions and regulatory approvals.
- Competitive pricing pressure in the TNF class could limit returns.
- Market statistics are dated third-party projections.
- This article is not investment advice.
What to watch next
- Closing announcement.
- ETICOVO launch date and contracting news.
- Teva commentary on biosimilars in coming results.
- Handover progress for infliximab-abda in 2027.
General background
Company information is on the Teva website and the Samsung Bioepis website. Regulatory background is available from the FDA biosimilars pages. See also our report on the Perjeta biosimilar Pebrilzo.
Questions readers are asking about the US biosimilars market
Are these products newly approved?
No. The FDA approved infliximab-abda in 2017 and ETICOVO in 2019.
What does Teva pay?
An upfront payment over three years plus possible milestones and a profit share; amounts are not disclosed.
When can ETICOVO launch?
Teva will announce timing later, after rights transfer at closing.
FAQ
Who manufactures the products?
Samsung Bioepis remains responsible for manufacturing and regulatory matters.
What are the reference medicines?
Enbrel for ETICOVO and Remicade for infliximab-abda.
Is the deal complete?
No. Closing is subject to customary conditions, including regulatory approvals.
How we reported this: details come from Teva’s announcement of 3 November 2026; market figures are attributed to Acumen Research And Consulting. Last updated 4 November 2026. This is news reporting and not investment or medical advice.
