STAT

OCTOBER 23, 2024

Amgen will launch its biosimilar version of a blockbuster Regeneron Pharmaceutical drug for an eye disease following a U.S. regulators in 2011. Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years. billion in U.S.

Compounding 239

Compounding Compounding Pharmacies Biosimilars Documentation 239

FDA Law Blog: Biosimilars

NOVEMBER 14, 2024

As reported in a recent publication (citations omitted): An estimated 129 million people in the US have at least 1 major chronic disease (eg, heart disease, cancer, diabetes, obesity, hypertension) as defined by the US Department of Health and Human Services. Undoubtedly, the public health and economic toll of chronic disease is staggering.

Labelling 64

Labelling Diabetes 64

pharmaphorum

MAY 17, 2021

The initial therapeutic focus is diabetes, with three insulin-based products in development. The Group’s third insulin product is a stable co-formulation of pramlintide and insulin, which has the potential to be a next generation treatment for both type 1 and type 2 diabetes.

Diabetes 52

Diabetes Biosimilars Hospitals Vaccines 52

Express Pharma

JANUARY 3, 2025

While India was able to leverage the 2008 patent cliff of small molecules, the same playbook will not work for biologics and biosimilars. Many biopharma companies in India have already leveraged the biosimilar patent cliff. Biocon became the first company from India to launch its biosimilar Hulio in the US in July 2023.

Biosimilars 105

Biosimilars Vaccines Diabetes 105