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California’s low-cost insulin plans receive $100m manufacturing boost

Pharmaceutical Technology

Insulin prices made the headlines again as California governor Gavin Newsom announced plans on 7 July for the state to manufacture low-cost insulin. The state plans to work directly with a contract manufacturing organization (CMO) to manufacture low-cost insulin. In-house manufacturing the norm.

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FDA okays Mylan insulin drug as first ‘interchangeable’ biosimilar

pharmaphorum

Generic drugmaker Mylan has become the first company to secure FDA approval for a biosimilar product that is considered completely interchangeable with the reference product – namely Sanofi’s once-daily insulin Lantus.

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Analyzing biosimilar market dynamics in different patient populations

Drug Patent Watch

Unlike traditional generic drugs, biosimilars face a more complex regulatory pathway and manufacturing process, which influences their market entry and adoption rates. ” Diabetes: Addressing a Global Epidemic With diabetes affecting millions worldwide, the advent of biosimilar insulins has been particularly impactful.

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FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. for the treatment of diabetes. Biosimilars marketed in the U.S.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “genericdrugs of the biopharma world. What is a Biosimilar?

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Eli Lilly Partners with Amazon Pharmacy for Home Delivery of Drugs

XTalks

LillyDirect Pharmacy Solutions, Eli Lilly’s direct-to-consumer (DTC) drugs website, is teaming up with Amazon Pharmacy to deliver select medications to people’s homes. The drugs include Lilly’s newly approved GLP-1 obesity drug Zepbound (tirzepatide), around a dozen of the company’s insulins and migraine drug Emgality (galcanezumab).

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A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

FDA Law Blog

That section of the bill – along with the other accompanying sections and parts of the bill – would amend Title XI of the Social Security Act to create a new part – Part E – requiring the HHS Secretary to establish a “Fair Price Negotiation Program” intended to lower prices for certain high-priced single-source drugs and biological products.