Q1 2025 Recap: Allergy

The first quarter of 2025 was informative for allergists worldwide, with hundreds attending the annual American Academy of Allergy, Asthma, & Immunology (AAAAI) meeting in San Diego (February 28 – March 3).

Experts discussed their latest research on peanut allergies, oral immunotherapy with autoclaved peanuts, and more. The first quarter also saw the US Food and Drug Administration (FDA) approve the first interchangeable biosimilar for omalizumab, along with newly published phase 2 and 3 data.

In this recap, we spotlight 1 regulatory update from the FDA and 3 top expert insights featured within our coverage.

Q1 2025 Regulatory Updates in Allergy

FDA Approves First Interchangeable Biosimilar for Omalizumab

The FDA approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar for reference omalizumab (Xolair). Omalizumab-igec also marked as the first respiratory biosimilar for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), immunoglobulin-E (IgE)-mediated food allergies, and chronic spontaneous urticaria (CSU).

Approved in 75 mg/0.5 mL and 150 mg/mL doses for subcutaneous use via prefilled syringes, its approval was based on a phase 3 study confirming its bioequivalence to the reference product in patients with CSU, demonstrating similar efficacy, safety, pharmacokinetics, and immunogenicity.

Q1 2025 Expert Perspectives in Allergy

Oral Immunotherapy Shows Promise for High Threshold Peanut Allergy, with Scott Sicherer, MD

At AAAAI 2025, HCPLive spoke with Sicherer, from Mt. Sinai School of Medicine, on a phase 2 trial showing 100% of children on peanut oral immunology tolerated 9043 mg of peanuts, versus 10% in the avoidance group.

Among 73 children aged 4 – 11 years with a high peanut allergy threshold (> 143 mg), the study assessed tolerance to 3400 mg of store-bought peanuts and then 9043 mg during the oral challenge.

“Typically, you would have said, “Oh, gee, you’re allergic to peanuts, don't eat it.” But with this information, you can make a very strong argument that if the family and child were interested in raising their threshold and eating the food more like regular food, although I would not call it a cure, it's still a treatment,” he said. “They could go through a process that's relatively simple, not a lot of visits with the doctor, and could end up having them eat peanut butter like regular food.”

Omalizumab Performs Better Than Oral Immunotherapy for Food Allergy, with Robert Wood, MD

Wood, from Johns Hopkins Medicine, discussed the OUtMATCH trial, which found omalizumab outperformed oral immunotherapy for food allergies (36% vs 19%; P = .031) in the intent-to-treat analysis. Participants had multiple food allergies, including peanuts and ≥ 2 other common food allergens, such as milk, egg, cashew, wheat, walnut, or hazelnut.

The per-protocol analysis showed no differences between treatment options. However, dropouts were considered a treatment failure, and there was a high dropout rate among patients undergoing oral immunotherapy and a low dropout rate among those on omalizumab.

“What I would take away from this is that oral immunotherapy does have potential benefit, but we need to be very clear with our patients about the high rate of side effects and the possibility that they really won't tolerate that treatment, whereas with omalizumab, we don't see side effect,” Wood said.

Patients Tolerate Oral Immunotherapy Better with Autoclaved vs Blanched Peanuts, with Casey Cohen, PhD

Cohen, from McGill University, presented late-breaking data at AAAAI showing that patients tolerate peanut oral immunotherapy with autoclaved peanuts better than with raw, roasted, or blanched peanuts. Peanuts were autoclaved at 266°F for 30 minutes.

Participants tolerated a maximum dose of 30 mg and a 44 mg cumulative dose, compared with a 9 mg for blanched peanuts. None on autoclaved peanuts required epinephrine, while on all blanched did.

“We are very confident that not only is it this autoclaving—this process—diluting the peanut from its proceeds, but we think it's actually changing it in a different way, making this a very unique substrate,” Cohen said. “It's changing it in such a way that we might have all these new things in this peanut there's still some level of those allergens there, which is important to reduce tolerance, but way less of it intact.”