Hormetic Stress Biohacking Type 1 Diabetes CGM

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Photo: Unsplash.com Medical Disclaimer : The content on this blog is purely for informational purposes only. For medical advice, diagnosis and treatment, consult your doctor. The ultimate goal for anyone living with Type 1 Diabetes (T1D) is stability. You want fewer spikes, fewer crashes, and more time spent in your target blood sugar range. Read more on blood sugar spike . For years, standard medical advice focused purely on matching insulin doses to carbohydrate intake. While this foundational math is necessary, it often leaves people riding a frustrating blood sugar roller coaster. Today, a new wave of tech-savvy individuals is looking beyond the traditional playbook. They are combining the principles of biohacking, the physiological benefits of hormetic stress, and the real-time data of Continuous Glucose Monitors (CGMs) to transform how they manage their health. This approach does not replace insulin. Instead, it aims to make the body more resilient, predictable, and res...
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FDA Approves First Interchangeable Biosimilars Drug to Treat Rheumatoid Arthritis and Ulcerative Colitis

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Rheumatoid Arthritis Hand. Photo: Unsplash.com


The Food and Drug Administration has approved Immgolis (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi (golimumab) and Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis. 

Immgolis and Immgolis Intri are the first biosimilars approved for Simponi and Simponi Aria, respectively. Immgolis is administered by subcutaneous injection in a single-dose prefilled syringe and Immgolis Intri is administered as an intravenous infusion prepared from a single dose vial.    

A biosimilar product is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference product. As a biosimilar product, Immgolis and Immgolis Intri can be used in place of Simponi and Simponi Aria.  

As an interchangeable biosimilar, Simponi and Simponi Aria may be substituted at the pharmacy for the reference product, depending on state laws.  

Immgolis and Immgolis Intri is a monoclonal antibody that binds to a protein called tumor necrosis factor alpha (TNFα). By binding TNFα, golimumab products stop it from triggering inflammation which helps improve signs and symptoms of these diseases.  

The expected side effects and adverse events for Immgolis and Immgolis Intri are consistent with those observed with Simponi and Simponi Aria. The most common expected side effects of Immgolis/Immgolis Intri, like Simponi/Simponi Aria, are upper respiratory tract infection, nasopharyngitis, and injection site reactions (incidence > 5%). 

Golimumab products can cause serious side effects including serious infections and malignancy (cancers). Patients treated with golimumab products are at increased risk for developing serious infections that may lead to hospitalization or death.  

The approval was based on comparisons across a broad range of structural and functional product quality attributes, including those known to impact safety and efficacy; a human pharmacokinetic similarity study showed comparable exposure and immunogenicity results in subjects treated with Immgolis and subjects treated with Simponi. 

The totality of these data supported FDA approval of Immgolis as an interchangeable biosimilar to Simponi and Immgolis Intri as an interchangeable biosimilar to Simponi Aria. 

Immgolis and Immgolis Intri (golimumab-sldi) is the 86th biosimilar product approved in the U.S for the 21st  unique reference product. The availability of biosimilar and interchangeable products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients. 


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