Also known as: Novolog, NovoLog
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
The European Commission granted marketing authorization to Sandoz for Bysumlog (insulin lispro) and Dazparda (insulin aspart), two biosimilar insulins developed by Gan & Lee Pharmaceuticals. A recent HHS analysis found most biosimilar markets become economically unviable after five competitors, prompting companies to diversify portfolios. Accord aims to bring 20 biosimilars to market by 2030.
Trump secured agreements with 16 pharmaceutical companies tied to TrumpRx.gov, including most-favoured-nation pricing and direct-to-patient discounts. Several companies disclosed price cuts for obesity, diabetes, insulin and other medicines.
Insulin list prices rose more than 300% over two decades as PBMs face growing scrutiny over rebates, spread pricing, and transparency. Reform efforts and pharmacist involvement are central to drug affordability and access.
President Trump imposes 100% tariffs on imported branded drugs from companies refusing price cuts or U.S. production moves. Sixteen major pharmaceutical firms have secured tariff exemptions by agreeing to align U.S. prices with other developed nations and invest in domestic manufacturing. The policy aims to reduce prescription drug costs and rebuild domestic pharmaceutical production capacity.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07076199 |
A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes |
RECRUITING | PHASE3 |
| NCT06547619 |
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM |
RECRUITING | EARLY_PHASE1 |
| NCT05946798 |
Role of NADPH Oxidase in Microvascular Dysfunction Following GDM |
ACTIVE_NOT_RECRUITING | EARLY_PHASE1 |
| NCT05946785 |
Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes |
RECRUITING | EARLY_PHASE1 |
