There have been68 biosimilarsapproved by the U.S. Food and Drug Administration (FDA). The most recent biosimilar approval wasMerilog(insulin aspart-szjj) on February 14, 2025. What is a Biosimilar? According the to FDA, a biosimilar is a biological product that is highly similar to, and ...
A biosimilar is not considered a “generic” in the same way that a traditional, small molecule drug (for example: ibuprofen or acetaminophen) is determined to be a generic. Biosimilars are "similar" because they are biologics that do not have to be exact copies of the active ingredient, as...
Biosimilar Drugs European regulatory authorities have adopted the term ‘biosimilars,’ while the US FDA prefers the term ‘follow-on biologics.’ It is important that ... AA Genazzani,G Biggio,AP Caputi,... - 《Biodrugs》 被引量: 30发表: 2007年 ...
A biosimilar is a drug that is highly similar to another approved biologic drug despite minor differences in clinically inactive components. Biosimilars exhibit no clinically meaningful differences in terms of efficacy and safety from the reference biologic drug.1 ...
Coupled with that is some of the utilization management tools payer mandates that also impact that, and so you may not have a choice but to use either a biosimilar, a brand, or generic that is underwater. And so, you're forced to choose that, a...
Drug IndustryBiosimilar PharmaceuticalsUnited StatesEd Silverman looks into the ongoing battle over whether biosimilars should have the same name as brand name biologicsWhat鈥檚 in a name? For the biopharmaceutical industry, much is at stake in answering this simple question. Around the globe, drug ...
A biosimilar is very similar to, but not an exact copy of, a biologic drug. You'll know that your medication is a biosimilar if it has a dash after the generic name, followed by four letters. Biologic drugs are harder to make than conventional medicines. While most traditional meds are ...
The cost of capital for early-stage biotechnology companies is almost twice as high as policymakers have assumed when crafting legislation for innovator biologies and biosimilar drugs, according to a new study. Findings from research com... E Jones - 《Washington Drug Letter》 被引量: 0发表: 20...
One way to solve this problem is that governments allow domestic companies to produce biosimilar versions of the drugs that are still under patent. For instance, Glivec, which is a specific medicine for leukemia, costs up to $50,000 per person per year. The patent application for Glivec was...
Rebates are paid: After a drug is dispensed, the manufacturer pays the negotiated rebate to the PBM or health plan. Rebates are (sometimes) shared: PBMs may pass a portion of the rebates to health plans or employers, who may in turn use them to lower premiums or out-of-pocket costs for...