Annotation from our pipeline tracker — GLP-1 receptor agonist competitive landscape, Q1 2026
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Recent issues covered:
- →Semaglutide patent cliff exposure — three biosimilar IND filings the press missed
- →FDA's Complete Response Letter to donanemab: what the clinical package actually said
- →Zilucoplan's formulary implications for hospital P&T committees, pre-approval
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In March 2023, a medical affairs director at a mid-size oncology company walked into a P&T committee meeting unprepared — not because she was careless, but because the FDA's Complete Response Letter on a competing agent had been filed at 4:47 PM on a Friday. By Monday morning, the competitive landscape had shifted. No newsletter caught it. No alert fired. That director was our first subscriber.
What a real issue looks like
GLP-1 Receptor Agonist Competitive Map
Full tracker: 47 molecules · Subscribers only
I forwarded the donanemab CRL analysis to our CMO before he'd seen it anywhere else. That email started a three-hour strategy session. Formulary paid for itself in one issue.
The PCSK9 Inhibitor Market Is About to Get Complicated
Inclisiran's six-month dosing advantage over evolocumab is about to face a credible challenger. A Phase III readout expected in Q2 carries implications for hospital formulary positioning that most P&T committees haven't modeled yet.
Alert
Two hospital systems in our subscriber base have already requested P&T briefing templates. Available in the subscriber toolkit.
We publish our calls. We track our accuracy. We show you both.
Ozempic's Patent Defense Strategy: What the Filing Actually Reveals
Novo Nordisk's supplemental patent applications contain a specific crystalline form claim that most generics analysts have overlooked. We walked through the prosecution history.
"As a hospital pharmacist, I used to find out about formulary-relevant approvals from a colleague in the hallway. Now I find out Thursday morning, with the clinical context already framed for my P&T presentation."
Three IND filings for semaglutide biosimilars in 60 days
Samsung Bioepis, Pfenex (Ligand), and a stealth-mode South Korean CMO filed INDs for GLP-1 biosimilar candidates within a 60-day window in late 2025. Combined, they represent the largest coordinated biosimilar entry signal we've tracked in the metabolic disease space since adalimumab.
We used the Phase II readout analysis on a competing molecule to sharpen our licensing pitch deck. The investor asked where we sourced the competitive intelligence. We said Thursday.
What you're missing right now
The Leqembi Formulary Decision Your Hospital's P&T Committee Hasn't Modeled Yet
Last Tuesday, CMS released draft National Coverage Determination language that will affect how hospital formulary committees handle lecanemab (Leqembi) coverage decisions through 2026. The language contains three subordinate clauses that most P&T analysts will misread on first pass — and at least one health system has already built a coverage policy around the wrong interpretation.
In this issue: the specific clause at issue, what it actually permits under Medicare Part B, the two hospital systems that got it right and how their pharmacy directors framed the committee discussion, and a template you can adapt for your own P&T submission.
Also this week: Zilucoplan's 90-day post-approval commitment letter surfaced on the FDA docket on Friday afternoon. We have the summary and the formulary implications for neurology departments that added it to formulary pre-approval...
- COVERAGECMS NCD language: what the subordinate clauses actually permit
- FORMULARYLecanemab P&T template — two health system models
- ALERTZilucoplan 90-day commitment letter: neurology formulary implications
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