BIO:ON Insight #4 · Jun 16, 2026
Copy, combine, or go where no drug has gone: three ways to make a new medicine
The first golimumab biosimilar wins FDA approval, BioNTech and BMS show early lung cancer data for a PD-L1×VEGF bispecific, and Orion reports first-in-human results for an oral pan-TEAD inhibitor. Copy, combine or create?
What I learned this week
What I found most interesting this week is that the stock reactions followed how mature the data was, not how new the idea was. The newest attempt, the new target, was the quietest. So the next time you see "first-in-class," check which phase it's in before getting excited. That habit alone keeps headlines from pushing you around. See you next issue. 🙏
Yaehyun Lee · Quoted from the Editor's Insight I wrote for this issue.
Stories in this issue
- FDA Approvals
Bio-Thera wins FDA approval for golimumab biosimilars
Bio-TheraUS FDA
- Clinical Trials
BioNTech and BMS: pumitamig ROSETTA Lung-02 interim Phase 2 data
BioNTechBristol Myers Squibbpumitamig
- Clinical Trials
Orion Pharma's oral pan-TEAD inhibitor ODM-212: first Phase 1 results
Orion Pharma
AI summary
- 1Bio-Thera won FDA approval for the first golimumab biosimilar to Simponi.
- 2BioNTech and BMS's PD-L1×VEGF bispecific pumitamig showed strong responses in first-line lung cancer, squamous and non-squamous.
- 3Orion Pharma reported first-in-human Phase 1 results for its oral pan-TEAD inhibitor ODM-212.
Relevant rolesR&DRegulatory affairsBD
Summary and tags generated by AI from the issue text.
References
- 1.Bio-Thera wins FDA approval for golimumab biosimilars (opens in a new tab)
Bio-Thera Solutions press release
- 2.BioNTech and BMS report interim Phase 2 data for pumitamig in ROSETTA Lung-02 (opens in a new tab)
BioNTech / BMS press release
- 3.
Related insights
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