The BioPharm Brief: Mounjaro, ADCs, and Biosimilars

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Here are today’s top three stories in two minutes.

First, the FDA has expanded Mounjaro to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who are at high risk. The approval is based on the SURPASS-CVOT trial, which compared tirzepatide head-to-head with dulaglutide and found Mounjaro non-inferior, with an 8% lower rate of cardiovascular death, heart attack, or stroke. The approval makes tirzepatide the first GIP/GLP-1 receptor agonist with this cardiovascular risk-reduction indication.

In oncology, DualityBio has licensed its DUPAC ADC payload platform to Genentech in a deal worth more than $1 billion. DualityBio will receive $45 million upfront, with additional development, regulatory, and commercial milestones plus royalties. The platform includes payloads designed to address tumors that are resistant or less responsive to topoisomerase inhibitor-based ADCs. DualityBio will lead development through Phase 1a, after which Genentech takes over.

And Formosa Pharmaceuticals has filed an EU clinical trial application for TSY-110, a proposed biosimilar to Roche’s trastuzumab emtansine, or Kadcyla. If successful, TSY-110 could become the first biosimilar alternative to the HER2-targeted ADC in major regulated markets. The pivotal trial will compare safety, tolerability, pharmacokinetics, and immunogenicity with the reference product.F

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

Key takeaways:

• Mounjaro wins a new cardiovascular indication: FDA approved tirzepatide to reduce cardiovascular risk in high-risk adults with type 2 diabetes, based on SURPASS-CVOT.
• Genentech makes a major ADC bet: DualityBio’s DUPAC payload platform was licensed in a deal worth more than $1 billion.
• Formosa moves a HER2 ADC biosimilar forward: TSY-110 is being developed as a trastuzumab emtansine biosimilar, adding another potential competitor in the ADC space.