products how-drugs-are-made biologics-and-biosimilars 
XTalks
NOVEMBER 28, 2023
Biosimilars have emerged as an important factor in modern healthcare, reshaping treatment accessibility and affordability. Biosimilars offer a promising pathway to reducing healthcare costs while maintaining the efficacy and safety profiles of their reference products, the originally approved biologic drugs.
FDA Law Blog
AUGUST 12, 2021
Koblitz — About two weeks ago, FDA made an exciting announcement (and it remains exciting even if we’re late posting about it): FDA approved the first interchangeable biosimilar. On July 30, 2021, FDA approved Semglee (insulin glargine-yfgn), an insulin product that relies on Lantus (insulin glargine) as its reference product.
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XTalks
MARCH 8, 2024
The US Food and Drug Administration (FDA) has granted approval to two of Sandoz’s biosimilars to Amgen’s blockbuster bone drugs Prolia (denosumab) and Xgeva (denosumab). The biosimilar injections, Jubbonti (denosumab-bddz) and Wyost (denosumab-bddz), are approved as interchangeable biosimilars to Prolia and Xgeva, respectively.
FDA Law Blog
FEBRUARY 2, 2023
Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 21 U.S.C. § 42 U.S.C. §
XTalks
OCTOBER 4, 2022
The US Food and Drug Administration (FDA) has approved Spectrum Pharmaceuticals’ Rolvedon (eflapegrastim-xnst) injection. Myelosuppressive drugs kill cancer cells and normal cells in the bone marrow, which diminishes the amount of normal red blood cells, white blood cells and platelets in the bone marrow and blood.
Pharma in Brief
JANUARY 10, 2024
Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma.
FDA Law Blog
JUNE 8, 2023
The pandemic also deeply impacted how industry and the government conduct their operations. By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency.
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