The BioPharm Brief: New Approvals, Biosimilar Competition, and Deeper Remission

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry.

Today, we’re looking at an expanded cancer treatment approval, a new biosimilar regulatory milestone, and clinical data raising the bar for remission in inflammatory bowel disease.

First, the FDA has expanded approval of ImmunityBio’s Anktiva plus BCG, to include patients with BCG-unresponsive non-muscle invasive bladder cancer whose tumors are papillary-only. The agency extended the existing indication by extrapolating efficacy data from patients with carcinoma in situ, rather than requiring separate efficacy results in the papillary-only population. The decision came nearly three months before the FDA’s target action date and broadens treatment options for patients who have not responded to BCG.

Next, Alvotech and Advanz Pharma have submitted AVT29, a proposed biosimilar to high-dose aflibercept, or Eylea 8 mg, to the European Medicines Agency. The companies say this is the first known regulatory submission worldwide for a biosimilar to the 8 mg formulation. That dose can allow treatment intervals of up to 16 weeks for certain patients, compared with eight weeks for the 2 mg formulation. The application builds on the companies’ existing European authorization for their aflibercept 2 mg biosimilar, Mynzepli. AVT29 remains investigational, and biosimilarity has not yet been established by regulators.

Finally, Eli Lilly has reported new analyses of mirikizumab, marketed as Omvoh, in ulcerative colitis and Crohn disease. At one year, 27.7% of patients with ulcerative colitis achieved comprehensive disease control, compared with 14% receiving placebo. In Crohn disease, 20.4% of patients achieved corticosteroid-free deep remission, compared with 2% receiving placebo. The analyses also found benefits among patients who had previously failed biologic treatment. These were post hoc analyses of existing Phase 3 trial data, not new primary endpoints or a new regulatory approval.

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Key takeaways

• Anktiva: FDA expands its bladder cancer indication to include papillary-only disease.
• AVT29: Alvotech and Advanz submit a proposed Eylea 8 mg biosimilar in Europe.
• Omvoh: Lilly reports new composite remission outcomes in ulcerative colitis and Crohn disease.