Insulin Pharmacy Regulation 
The Pharma Data
JULY 29, 2021
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.
XTalks
MARCH 17, 2025
Amylin, a hormone co-secreted with insulin, plays a key role in regulating appetite by enhancing leptins effects the hormone that signals fullness after eating. Petrelintide, Zealand Pharmas long-acting amylin analog, is currently in Phase II clinical development and is designed for once-weekly subcutaneous injections.
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XTalks
FEBRUARY 8, 2021
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.
Pharmacy Checkers
JULY 2, 2019
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.
XTalks
FEBRUARY 8, 2024
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
pharmaphorum
JANUARY 24, 2023
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.
pharmaphorum
OCTOBER 19, 2021
It is only the second fully interchangeable biosimilar to be approved by the US regulator, after Viatris got a green light for its Semglee (insulin glargine) product in the summer, which can now be substituted for Sanofi’s Lantus on dispensing at a pharmacy.
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