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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.

Insulin 52
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Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. Both drugs continue to dominate the diabetes and GLP-1 markets. It’s been widely marketed and is considered a leading medication in the SGLT2 inhibitor class. percent in the fourth quarter and decreased 56.7

Sales 52
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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

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Nine for 2023, part three: thriving or surviving?

pharmaphorum

Venture capital poured into the pandemic biotech markets and not every investment was good quality. Market volatility, inflation, and raised interest rates will all make investors cautious. Medicines distribution and supply is also an energy intensive and regulated business. Medicines manufacturing is energy intensive.

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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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The Drug Reimportation Law Curtails Wholesale Not Personal Importation: Who Knew?

Pharmacy Checkers

Canadian pharmacies sell these American-made drugs at much lower cost, but that law prevents companies from buying those drugs and re-selling them here. And in my comments to the FDA on Section 801 for Prescription Justice, I ask a lot of questions about how this might help create more regulated pathways for safe personal drug importation.

Drugs 61
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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.

Medicine 145