The BioPharm Brief: Biosimilars, Obesity Deals, and Crohn Disease Data

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry. Today, we’re looking at a key biosimilar regulatory milestone, a new obesity drug partnership, and clinical data in Crohn disease.

The FDA has accepted the biologics license application for FYB206, a proposed biosimilar to Merck’s Keytruda developed by Formycon and Zydus. It’s the first publicly announced Keytruda biosimilar under FDA review, and the application was submitted without a comparative phase 3 efficacy trial. A decision could come in the third quarter of 2027.

Roche is expanding its obesity research through a deal with Rona Therapeutics focused on an RNA interference therapy targeting ALK7. The agreement could be worth up to $1.06 billion, adding another approach to the race for treatments that go beyond existing weight-loss medicines.

And in Crohn disease, Johnson & Johnson’s guselkumab showed fistula remission in patients with a particularly difficult-to-treat complication. The FUZION study results included patients who had previously received biologic therapies, offering another look at the drug’s potential in this challenging patient population.

Thanks for listening to The BioPharm Brief. For further analysis and expert insights, please visit BioPharmInternational.com.

Key takeaways

• FYB206 advances to FDA review without a comparative phase 3 efficacy trial.
• Roche’s Rona deal adds an ALK7-targeting RNAi candidate to its pipeline.
• Guselkumab showed higher fistula remission rates than placebo in phase 3 subgroup analyses, including among patients previously treated with biologics.