EU Clears Subcutaneous Biologic for Lupus, Advancing Patient-Controlled Delivery

The European Commission (EC) has approved a subcutaneous, self-administered formulation of anifrolumab (brand name Saphnelo) from AstraZeneca for adults with systemic lupus erythematosus (SLE). The indication applies to patients receiving standard therapy and marks a regulatory milestone for biologic delivery in autoimmune disease, AstraZeneca announced on Dec. 16, 2025 (1). The EC’s decision enables use of a pre-filled pen that allows patients to self-administer treatment outside of infusion centers while maintaining the clinical profile established with intravenous dosing.

The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is based on results from a Phase III clinical trial (TULIP-SC) that evaluated subcutaneous administration in patients with moderate to severe, active, autoantibody-positive SLE. In that study, patients receiving weekly subcutaneous dosing experienced a statistically significant and clinically meaningful reduction in disease activity compared with placebo while continuing background therapy (2).

This decision reflects growing regulatory acceptance of alternative delivery formats for complex biologics. As health systems across Europe face capacity constraints in outpatient infusion settings, self-administration options are increasingly viewed as a mechanism to improve access without compromising clinical outcomes (3).

How does subcutaneous delivery change treatment access in SLE?

(SLE) affects more than 3.4 million people worldwide and disproportionately impacts women. The disease is associated with chronic inflammation, progressive organ damage, and elevated mortality risk in Europe compared with the general population. Although oral corticosteroids remain widely used, long-term exposure is linked to significant adverse effects and does not address underlying immune drivers (4,5).

“EU [European Union] approval of anifrolumab in a self-administered pre-filled pen is fantastic news for people living with systemic lupus erythematosus as clinicians now have the potential to reach a wider group of patients with this important medicine, which has been shown to significantly reduce disease activity and the risk of organ damage,” said Prof. Thomas Dörner, rheumatologist and professor of Rheumatology and Hemostaseology at Charité University Hospital, Berlin, Germany and investigator of the TULIP-SC trial, in a company press release (1). “Lupus has historically been overlooked, but with treatment recommendations now aiming for disease remission with earlier use of biologics and less reliance on oral corticosteroids, we’re beginning to see real momentum in delivering higher standards of care.”

Why does this approval matter for the broader biopharmaceutical landscape?

Approximately 70% of European patients receiving biologics for SLE already use subcutaneous therapies, highlighting a clear preference for non-infusion options. Regulatory endorsement of a subcutaneous interferon pathway inhibitor reinforces the trend toward decentralized care models (6).

“We are committed to improving lupus care and, since launch, Saphnelo IV infusion has transformed outcomes for tens of thousands of people living with systemic lupus erythematosus,” said Ruud Dobber, executive vice-president, BioPharmaceuticals Business Unit, AstraZeneca, in the release (1). “With approximately 70% of SLE patients on biologics in Europe using a subcutaneous self-administration option, today’s approval means we can now offer the clinically meaningful benefits of Saphnelo while expanding patient choice in how and where they receive treatment.”

Subcutaneous anifrolumab is currently under regulatory review in additional global markets, including the United States and Japan. The intravenous infusion version is approved for treating moderate to severe SLE in more than 70 countries, including the US, Eurpean Union, and Japan. Its progress will be closely watched as an indicator of how biologic innovation, delivery technology, and regulatory policy continue to converge in autoimmune disease care (1).

References

1. AstraZeneca. Saphnelo Approved in the EU for Subcutaneous Self-Administration as a New Pre-Filled Pen for Systemic Lupus Erythematosus. Press Release. Dec. 16, 2025.
2. AstraZeneca. Saphnelo Self-Administration TULIP-SC Phase III Trial Meets Primary Endpoint in Patients with Systemic Lupus Erythematosus Based on an Interim Analysis. Press Release. Sept. 17, 2025.
3. Zietse, M.; Hu, J.; van Staveren, E. R.; et al. Capacity and Cost Benefits of Subcutaneous Versus Intravenous Pertuzumab/Trastuzumab: The EASE-SC Study. Breast 2025, 84, 104573. DOI: 10.1016/j.breast.2025.104573
4. Bruce, I. N.; O'Keeffe, A. G.; Farewell, V.; et al. Factors Associated with Damage Accrual in Patients with Systemic Lupus Erythematosus: Results from the Systemic Lupus International Collaborating Clinics (SLICC) Inception Cohort. Ann. Rheum. Dis. 2015, 74 (9), 1706–1713. DOI: 10.1136/annrheumdis-2013-205171.
5. Guéry J. C. Why Is Systemic Lupus Erythematosus More Common in Women? Jt., Bone, Spine 2019, 86 (3), 297–299. DOI: 10.1016/j.jbspin.2018.12.004
6. Kundnani, N. R.; Levai, M. C.; Popa, M. D.; et al. Biologics in Systemic Lupus Erythematosus: Recent Evolutions and Benefits. Pharmaceutics 2024, 16 (9), 1176. DOI: 10.3390/pharmaceutics16091176