Finally, some potentially good news in the medications arena:
Move is latest broadside by Trump administration against pharmaceuticals industry that fought to derail changes
The US drugs regulator has said it will accelerate approvals for cheaper generic versions of complex biological medicines, threatening some of the pharmaceutical industry’s most profitable products.
The US Food and Drug Administration said on Wednesday it would ease requirements for generic biological medicines engineered with living cells. The agency recommended that human studies might not be necessary for drug companies when they develop generic versions of these biological drugs.
The changes come despite fierce lobbying by the industry’s top representatives in Washington, who have spent millions of dollars to derail less-expensive biological options.
The FDA’s move to speed up approvals builds on US President Donald Trump’s recent deals with companies to lower prices and heaps more pressure on the industry’s profits. US drug companies Eli Lilly, Pfizer, Merck and Bristol Myers Squibb have lagged the S&P 500 index this year in part because of uncertainty about Trump’s pricing scrutiny. The companies have warned shareholders about the threats posed by generic biological competition, regulatory filings show.
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Biosimilars were central to litigation involving AbbVie’s anti-inflammation medication Humira, which was the world’s bestselling drug from 2015 to 2019. AbbVie had charged $77,000 a year for the drug.
Read the full story: US set to speed up approval for some generic drugs in blow to Big Pharma (FT)
This story got me thinking about Humira as a potential life-extension drug.
My Prompt:
Summarize the scientific and clinical evidence that the anti-inflammation medication Humira could be helpful in healthspan and lifespan extension for healthy people
@DrFraser , and other medical professionals here, would you agree with the response from CGPT?
CGPT5 Response
Short answer: there’s no scientific or clinical evidence that adalimumab (Humira)—a TNF-α–blocking biologic—extends healthspan or lifespan in otherwise healthy people. What we do know comes from (a) theory about “inflammaging,” (b) patient-population studies in inflammatory diseases, and (c) the established risk profile of TNF inhibitors. Put together, the current balance of evidence argues against off-label use for longevity in healthy individuals.
What the science actually shows
- Theory (inflammaging): Chronic, low-grade elevation of pro-inflammatory cytokines—including TNF-α—is a hallmark of aging and is associated with frailty and age-related disease risk. This has led some to speculate that dampening TNF-α might improve aging biology. But these are conceptual frameworks and reviews—not clinical trials in healthy people.
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Patient populations (RA, PsA, IBD, psoriasis): In people with inflammatory diseases, TNF inhibitors (a class that includes adalimumab) reliably reduce disease activity. Observational and review data suggest fewer cardiovascular events versus non-biologics in these high-inflammation groups, and no clear increase in all-cause mortality over the medium term; however, these findings are not randomized head-to-head lifespan trials and are confounded by indication/severity.
- Example signals: Reviews/meta-analyses report reduced CV events with TNF inhibitors in RA; but this is benefit within disease, not in healthy people.
- There are no RCTs testing adalimumab to slow aging, improve global “healthspan” metrics, or extend life in healthy adults. (Aging/“longevity” drug overviews do not list adalimumab as a tested anti-aging agent in healthy people.)
- Animal/adjacent data: Some preclinical work with other TNF-pathway blockers (e.g., etanercept) has shown benefits in aged mice (sarcopenia models), and experimental “soluble TNF” inhibitors (e.g., XPro1595) have shown biomarker improvements in small Alzheimer’s studies. These are not adalimumab in healthy humans and don’t establish healthspan or lifespan extension.
The risk side (highly relevant to healthy users)
- Serious infections (including TB and invasive fungal infections): This is a boxed warning on adalimumab and class-consistent across labels and safety summaries. Reactivation of latent TB and other opportunistic infections is a well-documented risk.
- Observed safety in large datasets: Long-term adalimumab safety registries show infections are the most frequent serious adverse events, across indications. Multiple meta-analyses of TNF inhibitors report increased serious infection risk versus controls.
- Other concerns: Possible worsening of heart failure, demyelinating disease events, cytopenias, and malignancy warnings are part of the established safety profile—again, not attractive trade-offs for someone without an inflammatory diagnosis.
Bottom line for longevity use in healthy people
- Evidence of benefit: None in healthy humans (no trials demonstrating improved functional aging, slowed biological aging, or increased lifespan).
- Evidence of harm: Clear, class-level risks—especially serious infections and TB reactivation—plus other immunosuppression-related adverse events.
- Net assessment: In the absence of demonstrated benefit and given nontrivial risks, adalimumab should not be used for healthspan/lifespan extension in healthy individuals .
If you want, I can outline lower-risk, evidence-supported anti-inflammation strategies with actual data in generally healthy adults (e.g., exercise prescriptions, diet patterns, sleep optimization, select supplements with RCT biomarker effects), and how to instrument them with biomarkers you already track.