The Shift From Intravenous to Subcutaneous Biologics in 2026

The biopharmaceutical industry is pushing to shift biologic therapies from intravenous (IV) infusion to subcutaneous (SC) injection, bringing these therapies into patients’ homes rather than the clinic. Since early this year, regulators in the United States, Japan, and the European Union (EU) have cleared a wave of SC formulations, wearable on-body injectors, and half-life-extension platforms spanning oncology, neurology, and autoimmune disease, while drugmakers and technology licensors have signed major platform deals worth hundreds of millions of dollars to keep the SC biologics pipeline moving.

Real-world data are validating this shift, with SC administration shown to cut patient chair time by up to 96%,¹ whereas the wearable-injector device market is projected to nearly double from $6.5 billion in 2026 to $13.0 billion by 2035.² Mohamad Mohty, MD, PhD, professor of hematology at Sorbonne University and head of the Clinical Hematology and Cellular Therapy Department at Saint-Antoine Hospital, Paris, previously commented on one of the year’s marquee SC approvals, Sanofi’s isatuximab (Sarclisa), in SC formulation for multiple myeloma (MM). Mohty has noted that MM often requires repeated, prolonged clinic visits, which place a considerable burden on patients and their support networks.³ The following roundup surveys important developments in 2026 that most represent this shift via regulatory decisions, trial data, and dealmaking.

Which regulatory decisions are accelerating the IV-to-SC shift?

Regulators have been a major catalyst for the shift away from IV administration to SC. July 2026 saw the FDA approve the isatuximab SC formulation for MM, delivered via on-body injector, making it the first anticancer therapy available in the United States through both a wearable device and manual SC injection.⁴ In a phase 3 trial (IRAKLIA [NCT05405166]), the SC formulation matched IV isatuximab on overall response (71.7% vs 70.5%) while cutting infusion reactions from 25% to 1.5%.⁴ Halozyme chief medical officer Charles Theuer, MD, PhD, whose company’s Enhanze hyaluronidase technology underlies the formulation, has described the change as cutting administration time from hours down to minutes or, in some cases, seconds.⁴ The US approval followed earlier regulatory clearance in June 2026 from both the European Commission³ and Japan’s Ministry of Health, Labour and Welfare.⁵

The FDA also broadened SC access in neurology and autoimmune disease. Eisai and Biogen won the agency’s approval in July 2026 to use their once-weekly lecanemab-irmb (Leqembi Iqlik) autoinjector as an initiation dose for early Alzheimer disease, extending SC dosing to the start of treatment rather than just maintenance. It was shown that 94% of patients and caregivers found the device easy to use.⁶ AstraZeneca received clearance in April 2026 for a weekly SC autoinjector version of anifrolumab (Saphnelo), a self-administered alternative to monthly infusions, for systemic lupus erythematosus, with no change to the approved indication.⁷ Roche’s satralizumab (Enspryng) earned FDA priority review for thyroid eye disease (TED) in June 2026 and for myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) in September 2026, positioning it as the first SC option in both conditions. A decision is expected from the FDA by October 15, 2026, for the TED indication and by January 10, 2027, for MOGAD.^8,9

The oncology field delivered even further progress to SC biologic formulations. Johnson & Johnson’s SC amivantamab-hyaluronidase combination (Rybrevant Faspro) received priority review to expand from lung cancer into head and neck squamous cell carcinoma, in which it produced a 42% response rate in early testing.¹⁰ Meanwhile, a new European framework known as the Molecule-Independent Device Bridging Approach (MIDBA) lets sponsors pair an approved biologic with a previously validated auto-injector without repeating a full bioequivalence study every time the device changes.

“Before MIDBA, every time you made a presentation change, you had to do another bioavailability equivalent study,” Theuer said in a previous interview with BioPharm International^®.¹¹

He added that the broader IV-to-SC pathway has matured alongside that regulatory shift. “The pathway to convert from IV to sub q [subcutaneous] is actually very streamlined,” Theuer said, pointing to sequential pharmacokinetic study designs that let each patient serve as their own control and can shrink required trial sizes.¹²

These decisions show regulators treating SC conversion less as a novelty and more as a lifecycle management pathway pursued through supplemental applications, shortening timelines, and, in several cases, earning priority review status typically reserved for unmet medical need.

What clinical data support the case for SC conversion?

Beyond approvals, new trial and real-world data are reinforcing why sponsors are making the switch. Amgen’s phase 3 data for SC teprotumumab (Tepezza) showed a 76.7% proptosis response rate at week 24, vs 19.6% for placebo (P<.0001), matching the efficacy bar set by the intravenous original. Amgen’s executive vice president of research and development, Jay Bradner, MD, has stated that the company sees the SC option as a way to evolve how the medicine is delivered and potentially reach more patients through greater convenience.¹³

Separately, data presented at Digestive Disease Week 2026 indicated SC infliximab could recapture response in patients who had lost it on IV therapy.¹⁴ “Technically, it is a game changer for patients with IBD [inflammatory bowel disease],” said Juby Jacob-Nara, MD, DHSc, MPH, MBA, Celltrion’s chief medical officer and senior vice president, in an interview with BioPharm International during that conference.¹⁵ She cautioned, though, that convenience cannot outrun consistency. “Number one, the product has to work, and the patients have to get it, and the drug has to stay consistent to sustain the efficacy,” she added in the interview.

Independent research backs the pattern, showing that a capacity analysis of SC pertuzumab-trastuzumab found the switch cut patient chair time by 85.5% for maintenance doses and 96.0% for loading doses, while saving roughly €172 to €403 (US $200-$468) in direct administration costs per dose. This cut represents savings large enough that nationwide adoption in one health system could free capacity for 22,000 additional treatments annually.¹

How are licensing deals scaling the technology behind SC delivery?

The clinical and regulatory momentum is being underwritten by an active dealmaking market for the enabling technology itself. In July 2026, Halozyme Therapeutics expanded its Enhanze collaboration with Incyte to support a SC formulation of INCA033989, an antibody targeting mutant calreticulin in myeloproliferative neoplasms, a mutation present in 20% to 30% of patients with these blood cancers.¹⁶ The deal includes an upfront payment, milestones, royalties, and an option for Incyte to nominate 2 additional targets.

Following that deal, Alteogen licensed its Hybrozyme SC platform, built around the hyaluronidase ALT-B4, to an undisclosed global pharmaceutical company in a deal worth up to $365 million, marking another major SC biologic platform deal since January 2026.¹⁷ Both deals reflect economics evaluated in a 2024 review in mAbs, which quantified that 182 large-volume SC biopharmaceuticals, approximately 15% of the entire IV/SC biologic pipeline, now require enabling delivery technology to convert multihour infusions into single injections.¹⁸

What does the IV-to-SC shift mean for drug developers and CDMOs?

For manufacturers and their contract partners, the implications extend beyond any single approval. The wearable-injector market’s projected climb to $19.77 billion by 2035 is drawing device specialists such as BD, Enable Injections, Insulet, Medtronic, and Ypsomed deeper into pharma partnerships, while contract development and manufacturing organizations are being asked to add fill/finish and device-assembly capacity for prefilled syringes and on-body injectors alongside traditional vial lines.²

In addition, formulation scientists must continue to address a persistent constraint: fitting high-concentration antibody doses into the small, low-viscosity volumes that an SC injection can tolerate.¹⁸ With regulators now routing many conversions through supplemental applications and priority review rather than de novo filings, SC reformulation has become a standard lifecycle management strategy that may affect industry investment for the rest of the decade. As Theuer’s and Jacob-Nara’s insights highlight, patient convenience and reduced clinical infusion burden are no longer secondary considerations layered onto an already-approved biologic but rather design requirements that shape how new therapies reach the market in the first place.

References

1. Zietse M, Hu J, van Staveren ER, 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
2. Wearable injectors market by type of device, type of degree of automation, type of usability, type of therapeutic area, and geographical regions - trends and forecast till 2035. ResearchAndMarkets.com. July 2026. Accessed August 27, 2026. https://www.researchandmarkets.com/report/wearable-injector
3. Sanofi’s Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector. News release. Sanofi. June 8, 2026. Accessed August 27, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-08-05-00-00-3307781
4. Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector. News release. Sanofi. July 10, 2026. Accessed August 27, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-07-10-12-35-09-3325483
5. Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma. News release. Sanofi. June 19, 2026. Accessed August 27, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-19-10-31-15-3314694
6. FDA approves Leqembi Iqlik (lecanemab-irmb) subcutaneous injection as an initiation dose for early Alzheimer’s disease. News release. Biogen. July 13, 2026. Accessed August 27, 2026. https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembi-iqlikr-lecanemab-irmb-subcutaneous
7. Saphnelo approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus. News release. AstraZeneca. April 27, 2026. Accessed September 10, 2026. https://www.astrazeneca.com/media-centre/press-releases/2026/saphnelo-self-administration-approved-in-the-US.html
8. FDA grants priority review to Genentech’s application for Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED). News release. Genentech. June 29, 2026. Accessed September 10, 2026. https://www.gene.com/media/press-releases/15118/2026-06-29/fda-grants-priority-review-to-genentechs
9. US FDA grants priority review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments. News release. Roche. September 10, 2026. Accessed September 10, 2026. https://www.roche.com/media/releases/med-cor-2026-09-10
10. Johnson & Johnson’s Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) receives US FDA priority review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer. News release. Johnson & Johnson. July 30, 2026. Accessed September 10, 2026. https://www.jnj.com/media-center/press-releases/johnson-johnsons-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-receives-u-s-fda-priority-review-as-potential-first-in-class-egfr-and-met-targeted-subcutaneous-treatment-for-advanced-head-and-neck-cancer
11. Schoenthaler E, Theuer C. EU’s MIDBA framework could eliminate repetitive PK bridging studies for auto-injectors. BioPharm International. May 14, 2026. Accessed September 10, 2026. https://www.biopharminternational.com/view/eu-s-midba-framework-could-eliminate-repetitive-pk-bridging-studies-for-auto-injectors
12. Schoenthaler E, Theuer C. Sequential PK study designs may further accelerate IV-to-subcutaneous biologic development. BioPharm International. May 14, 2026. Accessed September 10, 2026. https://www.biopharminternational.com/view/sequential-pk-study-designs-may-further-accelerate-iv-to-subcutaneous-biologic-development
13. Amgen announces positive topline phase 3 results for subcutaneous Tepezza in adults living with moderate-to-severe active thyroid eye disease. News release. Amgen. April 6, 2026. Accessed September 10, 2026. https://www.amgen.com/newsroom/press-releases/2026/04/amgen-announces-positive-topline-phase-3-results-for-subcutaneous-tepezza-in-adults-living-with-moderate-to-severe-active-thyroid-eye-disease
14. Schoenthaler E, Jacob-Nara J. Subcutaneous infliximab shows promise for durable, patient-centered IBD care. BioPharm International. May 26, 2026. Accessed September 10, 2026. https://www.biopharminternational.com/view/subcutaneous-infliximab-shows-promise-for-durable-patient-centered-ibd-care
15. Schoenthaler E, Jacob-Nara J. Subcutaneous infliximab may improve convenience, adherence, and sustained remission in IBD care. BioPharm International. May 22, 2026. Accessed September 10, 2026. https://www.biopharminternational.com/view/subcutaneous-infliximab-may-improve-convenience-adherence-and-sustained-remission-in-ibd-care
16. Halozyme announces global collaboration and license agreement with Incyte to support the development of subcutaneous formulations of INCA033989 using its Enhanze technology. News release. Halozyme Therapeutics. July 20, 2026. Accessed September 10, 2026. https://ir.halozyme.com/news/news-details/2026/Halozyme-Announces-Global-Collaboration-and-License-Agreement-with-Incyte-to-Support-the-Development-of-Subcutaneous-Formulations-of-INCA033989-Using-its-ENHANZE-Technology/default.aspx
17. Alteogen announces exclusive license agreement with a global pharmaceutical company for the development and commercialization of a Hybrozyme-enabled subcutaneous biologic product. News release. Alteogen. August 5, 2026. Accessed August 5, 2026. https://www.prnewswire.com/news-releases/alteogen-announces-exclusive-license-agreement-with-a-global-pharmaceutical-company-for-the-development-and-commercialization-of-a-hybrozyme-enabled-subcutaneous-biologic-product-302843463.html
18. Green P, Schneider A, Lange J. Navigating large-volume subcutaneous injections of biopharmaceuticals: a systematic review of clinical pipelines and approved products. MAbs. 2024;16(1):2402713. doi:10.1080/19420862.2024.2402713