Home » 2026 Global Biosimilars Market Midyear Review » Biosimilar Approvals and Launches in H1 2026
Biosimilar Approvals and Launches in H1 2026
Chapter of the 2026 Global Biosimilars Market Midyear Review
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H1 2026 produced biosimilar approvals across a wider set of drug classes than any recent half, and several reference molecules faced biosimilar competition for the first time. The breadth of the approvals matters more than the count because entry into a class with no prior biosimilar carries a different commercial profile from entry as the eighth or tenth competitor on an established molecule. The two profiles also place different demands on the entrant, and the maturity of the first-wave classes is the reason development cost has become decisive for companies.
This chapter of Alira Health’s 2026 Global Biosimilars Market Midyear Review sets out the biosimilar approvals granted in the United States (US) and the marketing authorizations granted in the European Union during H1 2026, with the date, molecule, reference product, and company for each entry.
United States
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Source: Food and Drug Administration (FDA); company disclosures; GaBI Online; Alira Health analysis.
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Main US FDA Biosimilar Approvals, H1 2026
| Date | Product | Molecule/ Reference | Company | Note |
|---|---|---|---|---|
| Jan 15 2026 | FILKRI (filgrastim-laha) | Filgrastim/ Neupogen® | Accord BioPharma (Intas Pharmaceuticals) | First biosimilar Biologics License Application approval of 2026 |
| Mar 27 2026 | PONLIMSI (denosumab-adet) | Denosumab/ Prolia® | Teva Pharmaceuticals | 10th FDA-approved denosumab biosimilar |
| Apr 29 2026 | LANGLARA (insulin glargine-aldy) | Insulin glargine/ Lantus® | Sunshine Lake Pharma Co., Ltd./Lanexa Biologics (Lannett) | Interchangeable; third insulin glargine biosimilar in the US and the first from a Chinese developer |
| May 7 2026 | ENNUMO (pegfilgrastim-pccg) | Pegfilgrastim/ Neulasta® | Accord BioPharma (Intas Pharmaceuticals) | 8th FDA-approved pegfilgrastim biosimilar; Accord's second pegfilgrastim biosimilar (alongside UDENYCA®, acquired from Coherus BioSciences) |
| May 15 2026 | Immgolis/Immgolis Intri (golimumab-sldi) | Golimumab/ Simponi®, Simponi Aria® | Bio-Thera Solutions/ Accord BioPharma (Intas Pharmaceuticals) | First golimumab biosimilars approved in the US; interchangeable designation; brings cumulative FDA biosimilar approvals to 86 |
|
Jun 2 2026 |
Ranluspec (ranibizumab-hkdz) | Ranibizumab/ Lucentis® | Lupin Limited | Interchangeable; fourth interchangeable ranibizumab biosimilar; brings cumulative FDA biosimilar approvals to 87; also authorized in the EU |
The US approvals of H1 2026 show two commercially relevant features:
Breadth: The six approvals (seven product names, since Immgolis and Immgolis Intri were cleared together) spanned six reference molecules across five therapeutic areas, combining market-opening approvals, including the first US golimumab biosimilars, with additional competition in established classes, including the tenth denosumab and the eighth pegfilgrastim biosimilar.
Interchangeability: Three of the six approvals carried an FDA interchangeability designation, namely Langlara, Immgolis and Immgolis Intri, and Ranluspec. Subject to state law, an interchangeability designation permits pharmacist-level substitution without prior consultation of the prescriber and removes one practical barrier to uptake. Interchangeability does not by itself determine market share; formulary position, contracting terms, supply reliability, and patent litigation will continue to govern the pace at which approvals convert into revenue.
European Union
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Source: European Commission; EMA/CHMP; company disclosures; GaBI Online; Pearce IP; Allira Health analysis.
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Main European Commission Biosimilar Marketing Authorizations, H1 2026
| Date | Product | Molecule/ Reference | Company | Status |
|---|---|---|---|---|
| Jan 08 2026 | Osqay | Denosumab/Prolia | Theramex Ireland | European Commission (EC) marketing authorization (Committee for Medicinal Products for Human Use (CHMP) opinion Nov 13, 2025) |
| Jan 09 2026 | Ondibta | Insulin glargine/ Lantus | Gan & Lee Pharmaceuticals/Sandoz | European Commission marketing authorization (CHMP opinion Nov 13, 2025) |
| Feb 10 2026 | Gotenfia | Golimumab/Simponi | Bio-Thera Solutions/STADA | European Commission marketing authorization (CHMP opinion Dec 11, 2025) |
| Feb 10 2026 | Ranluspec | Ranibizumab/ Lucentis | Lupin Limited/Sandoz | European Commission marketing authorization (CHMP opinion Dec 11, 2025); also, FDA-approved Jun 5, 2026) |
| Apr 23 2026 | POHERDY | Pertuzumab/Perjeta® | Shanghai Henlius Biotech/Organon | European Commission marketing authorization (CHMP opinion Feb 26, 2026); first pertuzumab biosimilar in Europe; already FDA-approved as interchangeable (Nov 2025) |
| Apr 27 2026 | Tuyori |
Tocilizumab/ RoActemra® |
Gedeon Richter/ Mochida Pharmaceutical | European Commission marketing authorization (CHMP opinion Feb 26, 2026) |
| Apr 27 2026 | Dazparda | Insulin aspart/ NovoRapid® | Gan & Lee Pharmaceuticals/Sandoz | European Commission marketing authorization (CHMP opinion Feb 26, 2026) |
| Apr 27 2026 | Zandoriah | Teriparatide/ Forsteo® | CinnaGen | European Commission marketing authorization (CHMP opinion Feb 26, 2026); CinnaGen's first EU authorization |
|
May 06 2026 |
Bysumlog | Insulin lispro/ Humalog® | Gan & Lee Pharmaceuticals/Sandoz | European Commission marketing authorization (CHMP opinion Feb 26, 2026) |
| Jun 19 2026 | Rexatilux |
Ranibizumab/ Lucentis |
Intas Pharmaceuticals |
European Commission marketing authorization (CHMP opinion 23 Apr, 2026) |
The European Union showed broader diversification than the US. Ten European Commission authorizations covered nine reference molecules across five therapeutic areas, combining market expansion, including the first pertuzumab biosimilar in the European Union, with deeper competition on established molecules, including two additional ranibizumab products and three insulin analogues. The three authorizations held by Gan & Lee Pharmaceuticals with Sandoz, covering insulin glargine, insulin lispro, and insulin aspart, are strategically significant because they create a coordinated portfolio spanning basal and rapid-acting mealtime insulin. This breadth allows Sandoz to offer a basal-and-prandial insulin package and strengthens its position in European tender markets by enabling it to bid across multiple insulin categories or lots rather than for a single molecule. These three biosimilar authorizations came as Sandoz was completing its acquisition of the Just-Evotec Biologics manufacturing site. The two moves were independent: the Gan & Lee insulin portfolio was licensed to broaden Sandoz’s product offering, while the Toulouse site was acquired to expand manufacturing capacity, as detailed in the deals chapter.
European Commission authorization does not determine pharmacy-level substitution, which remains subject to national rules, so commercial impact depends on country-level launch sequencing, pricing and reimbursement, tender access, and national substitution policy.
Six new approvals in the US and ten in the European Union, with some presenting the first biosimilar for a molecule and others entering as competition for an established molecule, reinforce the strength and diversity of the biosimilar market today.
As the market matures, regulatory approval is increasingly only the starting point. Interchangeability, portfolio breadth, launch sequencing, pricing and reimbursement, tender access, contracting, supply reliability, and national substitution policies will all influence whether an approved biosimilar achieves meaningful uptake. For developers, this makes molecule selection and commercialization strategy increasingly important alongside the ability to secure approval itself.
Sources
Accord BioPharma, Inc. (2026, February 17). FDA approves FILKRI™ (filgrastim-laha), Accord BioPharma’s biosimilar to NEUPOGEN® (filgrastim) [Press release]. https://www.prnewswire.com/news-releases/fda-approves-filkri-filgrastim-laha-accord-biopharmas-biosimilar-to-neupogen-filgrastim-302689073.html
Alira Health. (2026). H1 2026 biosimilar market analysis [Internal analysis based on company and regulatory disclosures].
Big Molecule Watch (Goodwin). FDA approvals [Database]. https://www.bigmoleculewatch.com/fda-approved-ablas/
Bio-Thera Solutions, Ltd. (2026, May 18). Bio-Thera Solutions’ golimumab biosimilars receive FDA approval as first biosimilars to Simponi® and Simponi Aria®; Accord BioPharma to commercialize IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi) in the United States [Press release]. https://www.prnewswire.com/news-releases/bio-thera-solutions-golimumab-biosimilars-receive-fda-approval-as-first-biosimilars-to-simponi-and-simponi-aria-accord-biopharma-to-commercialize-immgolis-golimumab-sldi-and-immgolis-intri-golimumab-sldi-in-the-united-st-302774570.htmlhttps://www.bio-thera.com/col_62/1421.html
European Commission. Union Register of medicinal products for human use [Database]. https://health.ec.europa.eu/medicinal-products/union-register_en
European Medicines Agency, Committee for Medicinal Products for Human Use. (2025, November 13). Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 10–13 November 2025 [Meeting highlights]. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-10-13-november-2025
European Medicines Agency, Committee for Medicinal Products for Human Use. (2025, December 11). Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 8–11 December 2025 [Meeting highlights]. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-8-11-december-2025
European Medicines Agency, Committee for Medicinal Products for Human Use. (2026, February 26). Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 23–26 February 2026 [Meeting highlights]. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-february-2026
European Medicines Agency, Committee for Medicinal Products for Human Use. (2026, April 23). Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 20–23 April 2026 [Meeting highlights]. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-april-2026
GaBI Online. Biosimilars approved in the US [Database]. https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
GaBI Online. Biosimilars approved in Europe [Database]. https://gabionline.net/biosimilars/general/biosimilars-approved-in-europe
Lannett Company, Inc. (2026, May 4). Lannett Company, Lanexa Biologics and Sunshine Lake Pharma announce FDA approval of LANGLARA™, an interchangeable biosimilar of Lantus® (insulin glargine) [Press release]. https://www.businesswire.com/news/home/20260504761789/en/Lannett-Company-Lanexa-Biologics-and-Sunshine-Lake-Pharma-announce-FDA-Approval-of-LANGLARA-an-Interchangeable-Biosimilar-of-Lantus-insulin-glargine
Pearce IP. (2026, February 17). FDA approves Accord BioPharma’s filgrastim biosimilar [Specialist tracker]. https://www.pearceip.law/2026/02/17/fda-approves-accord-biopharmas-filgrastim-biosimilar/
Pearce IP. (2026, May 4). FDA approves Lannett/Sunshine Lake’s interchangeable biosimilar insulin glargine [Specialist tracker]. https://www.pearceip.law/2026/05/04/fda-approves-lannett-sunshine-lakes-interchangeable-biosimilar-insulin-glargine/
Pearce IP. (2026, May 18). Bio-Thera/Accord BioPharma secure first FDA approval of golimumab biosimilars [Specialist tracker]. https://www.pearceip.law/2026/05/18/bio-thera-accord-biopharma-secure-first-fda-approval-of-golimumab-biosimilars/
U.S. Food and Drug Administration. (2026). Biosimilar product information [Database]. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
Other report chapters
- Global Biosimilars Market in 2026: Challenges, Opportunities, and Changes
- Changes in the Biosimilar Regulations in H1 2026 in the US and Europe
- Generics Companies’ Positioning in Biosimilar Industry in H1 2026
- Biosimilar Deals: M&A and Licensing in H1 2026
- What to Watch in the Biosimilar Market in H2 2026 and Beyond