Erythropoietin

References include EU directives on medicinal products, guidelines on similar biological products, and studies on various medicinal products and their evaluations.

aTyr Pharma appoints Eric Benevich to its Board of Directors, effective December 10, 2024. Benevich, currently Chief Commercial Officer at Neurocrine Biosciences, brings over 30 years of pharmaceutical commercial experience. aTyr is a clinical-stage biotech focused on tRNA synthetase biology for fibrosis and inflammation therapies.

Dr. Marty Makary, Trump's FDA nominee, questions conventional medical wisdom in his book 'Blind Spots,' advocating alternative treatments and criticizing medical establishment 'groupthink.' His potential leadership could shift FDA focus to food regulation, but his book's selective use of evidence raises concerns about undermining FDA's drug approval standards and public trust. Makary's contrarian views, often based on observational studies, contrast with FDA's traditional reliance on rigorous clinical trials.

Amgen reports Q3 2024 financial results: total revenues up 23% to $8.5 billion, GAAP EPS increased 62% to $5.22, non-GAAP EPS up 13% to $5.58, driven by strong product sales and pipeline investments.

Adalimumab biosimilars' market share rose from 2% to 22% in early 2024, driven by private label brands. The FDA approved 61 biosimilars across 17 molecules, with 41 launched in the US. Biosimilars' average sales prices decreased by 53% over 5 years. Major PBMs like CVS Caremark and Evernorth are adding biosimilars to formularies. Adalimumab biosimilars offer multiple pricing options, with some at 85-86% less than Humira. Biosimilars saved payers $1.6 PMPM, with potential for further growth.