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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. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S.

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Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

In its 2022 financial report, Sanofi reported that sales of the long-acting insulin dropped 27.6 percent in the US, impacted by prior formulary losses as well as “erosion of the basal insulin market,” the company said in the statement. In its 2022 financial report, Sanofi reported that sales of the long-acting insulin dropped 27.6

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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Public Comment to the WHO About Online Access to Imported Medicines and SDG 3.8

Pharmacy Checkers

Determinants of Health: Providing regulatory space to promote safe international Internet pharmacy practice in furtherance of SDG 3.8 the Internet, via international online pharmacies, has helped tens of millions of Americans obtain medicines from pharmacies in other countries. [v]. My comment is below. Author: Gabriel Levitt.

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Nine for 2023, part three: thriving or surviving?

pharmaphorum

Heating, ventilation, and air conditioning (HVAC) systems for validated cleanroom areas of a plant, for example, are essential and subject to stringent regulation, and consume many times more energy than non-validated areas. Medicines distribution and supply is also an energy intensive and regulated business.

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A history of the pharmaceutical industry

pharmaphorum

The 21st century pharmaceutical and biotech sector has come a long way from its roots in 19th century pharmacy. Originating as a pharmacy founded in Darmstadt in 1668, it was in 1827 that Heinrich Emanuel Merck began the transition towards an industrial and scientific concern, by manufacturing and selling alkaloids.

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Pricing, Profits and Progress: Pharma’s Post-COVID Priorities

pharmaphorum

The fundamental misconception among the public, the media and even some lawmakers is that higher drug list prices are the result of drug manufacturers being in a monopolistic position to endlessly raise prices on critical drugs like insulin and then rake in big profits. Is the Middleman at Fault?