New self-injectable biologics promise cost savings and patient convenience

More biologic therapies are switching from intravenous (IV) administration to subcutaneous (SC) and autoinjector administration. Pharmaceutical companies have prioritized research efforts for their often blockbuster therapies. A study published in October 2025 in the Journal of Controlled Release found that the clinical development of high-dose biologics is shifting from IV to SC administration. One analysis, published in the journal mAbs in September 2024 about the industry’s pipeline, identified 182 large-volume subcutaneous therapies in development.

For example, the majority of the obesity pipeline is focused on subcutaneous delivery formulations, with 95 drugs (54%) being studied for this formulation, according to research published in March 2025 by the IQVIA Institute for Human Data Science.

We’re starting to see this trend with the new approvals of biologics for cancer. The subcutaneous formulations offer shorter injection times and enable a shift from a hospital setting to an outpatient setting or self-injection at home. They also change how insurance companies reimburse for these drugs. IV drugs are reimbursed through the medical benefit, while subcutaneous injections are covered through the pharmacy benefit.

Recent subcutaneous approvals

Keytruda QLex: Merck received approval of the cancer therapy Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), an SC version of the Keytruda programmed death receptor-1 (PD-1). Keytruda Qlex is approved for most of Keytruda’s indications. This is the second PD-1-blocking antibody; Bristol Myers Squibb’s Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) was approved in December 2024.

Keytruda Qlex’s approval applies to most of the 38 tumor indications for which IV Keytruda has already been approved. These include non-small cell lung cancer (NSCLC), melanoma, head and neck cancers, and others for which immunotherapy has become part of standard treatment.

The FDA’s decision was supported by Study 3475A-D77, a multicenter, randomized phase 3 trial that compared Keytruda Qlex given with chemotherapy with IV Keytruda with chemotherapy in patients with advanced metastatic NSCLC that had not yet been treated or who had no EGFR, ALK or ROS1 genomic tumor aberrations.

Merck has not yet announced the price for Keytruda Qlex. The list price for IV Keytruda given every three weeks is $12,031.36. The list price when given every six weeks is $24,062.72.

This is the second SC-administered PD-1-blocking antibody, following Bristol Myers Squibb’s Opdivo Qvantig, which was approved in December 2024. Opdivo Qvantig (nivolumab + hyaluronidase-nvhy) is priced at parity with Opdivo IV 240 mg/24 mL at $7,943 per infusion.

Leqembi: The FDA has approved a subcutaneous version of the Alzheimer’s therapy Leqembi. Called Leqembi Iqlik (lecanemab-irmb), it is a once-weekly SC autoinjector that is indicated for maintenance dosing (after 18 months of receiving Leqembi IV every two weeks) to treat Alzheimer’s disease in patients with mild cognitive impairment or mild dementia. The SC version allows the medication to be given in 15 seconds rather than during an hour-long infusion. This is the first anti-amyloid subcutaneous injection approved for Alzheimer’s disease.

Developed by Eisai and co-marketed with Biogen, Leqembi Iqlik launched in October 2025, with a wholesale acquisition cost of $375 per autoinjector (or $19,500 annually). Leqembi IV has a list price of $26,632 a year. Eisai officials said in a statement that patients with Medicare Part D coverage are subject to an annual out-of-pocket cap of $2,000, and some patients, depending on their plan, may have a copay that is less than the annual cap.

An analysis sponsored by Eisai and published in July 2025 found that using Leqembi Iqlik could result in per-patient savings of between $72,891 and $80,925 over four years compared with Leqembi IV. These savings are driven by reduced treatment costs attributed to a more efficient fixed-dose autoinjector delivery, lower administrative costs, and reduced time spent by healthcare providers, patients and care partners.

Tremfya: In March 2025, Johnson & Johnson’s Tremfya (guselkumab) was approved as a subcutaneous option for the treatment of adults with moderate-to-severe active Crohn’s disease. In September 2025, the subcutaneous version was also approved to treat moderate to severe active ulcerative colitis in adults.

Tremfya is a monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases.

Historically, IL-23 inhibitors have required IV infusions at the start of therapy. The subcutaneous option for ulcerative colitis was approved based on results from the phase 3 placebo.

Subcutaneous products in development

Amivantamab: J&J is also conducting trials on a subcutaneous version of amivantamab monotherapy in patients with human papillomavirus (HPV)-unrelated, recurrent, or metastatic head and neck squamous cell carcinoma. The subcutaneous formulation can be delivered in a five-minute manual injection.

The already approved Rybrevant (amivantamab-vmjw) is a fully human bispecific antibody that targets EGFR and MET with immune cell-directing activity. It is approved in the United States and other markets as monotherapy to treat adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.

In October 2025, the company announced new results from the phase 1b/2 OrigAMI-4 study, which found that responses were rapid and durable, and tumor shrinkage was observed in 82% of patients. In Cohort 1 of the OrigAMI-4 study, treatment with SC amivantamab resulted in an overall response rate of 45% in 38 efficacy-evaluable patients with metastatic head and neck squamous cell carcinoma. Median progression-free survival was 6.8 months.

The company is initiating a phase 3 trial of the subcutaneous version of amivantamab in the head and neck cancer patient population.

Subcutaneous amivantamab is also being studied across multiple tumor types, including non-small cell lung cancer.