The BioPharm Brief: A Psoriatic Arthritis Approval, a Subcutaneous Fabry Bet, and ADC Capacity

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Today, we’re looking at a new approval in psoriatic arthritis, a licensing deal that could bring the first subcutaneous enzyme replacement therapy to Fabry disease, and new manufacturing capacity for antibody-drug conjugates.

First, FDA has approved Sun Pharma’s Ilumya for adults with active psoriatic arthritis. Ilumya, or tildrakizumab, is a monoclonal antibody that blocks IL-23, a protein that drives inflammation. Two phase 3 trials with more than 800 adults met their primary goal at week 24, including patients who had and had not previously tried TNF inhibitors. Ilumya is dosed every 12 weeks after the first dose. It is the third IL-23 blocker approved for psoriatic arthritis and the only one given exclusively by a healthcare provider. About 2.4 million Americans live with the condition.

Next, BioMarin has licensed an investigational subcutaneous enzyme replacement therapy for Fabry disease from GC Biopharma and Hanmi. Fabry disease is a rare inherited disorder in which a missing enzyme allows fatty substances to build up, damaging the kidneys, heart, and nerves. The long-acting candidate is designed to be injected under the skin. BioMarin says it could become the first subcutaneous enzyme replacement therapy for the disease. BioMarin will pay $70 million upfront and up to $405 million in milestones. A phase 1/2 safety study is ongoing, and no clinical data have been reported yet.

And Lonza is expanding its bioconjugation capacity in Visp, Switzerland, to meet rising demand for antibody-drug conjugates, or ADCs. These drugs link an antibody to a potent payload that it delivers directly to cancer cells. Lonza is upgrading its mid-scale suites to a 500-liter single-use platform by 2027. It is also building a new facility with three multiproduct suites at scales up to 1,200 liters, expected to begin operations in 2028. The expansion follows a run of recent phase 3 ADC results across lung, endometrial, and other cancers.

That’s today’s BioPharm Brief. For analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways

• New approval: Ilumya is the third IL-23p19 inhibitor approved for active psoriatic arthritis and the only one given exclusively by a provider.
• Rare disease licensing: BioMarin’s deal for HM15421/GC1134A could bring the first subcutaneous enzyme replacement therapy to Fabry disease.
• ADC manufacturing: Lonza’s Visp expansion adds single-use and large-scale bioconjugation capacity, with operations starting in 2027 and 2028.