Search Results for:

Executive Order for Advancing Biotechnology and Biomanufacturing Innovation Signed by President Biden

On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order is to “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food…

Read More

European Regulatory Heads Make Biosimilars Interchangeable

On September 19, 2022, the European Medicines Agency’s (“EMA”) Biosimilar Medicines Working Party (“BMWP”) and the Heads of Medicines Agencies (“HMA”), a network of the heads of the authorities responsible for the regulation of medicinal products for human use in the European Economic Area, issued a Joint Statement confirming that…

Read More

Alvotech Announces Reaching the Primary Completion Date in Its AVT02 Switching Study

On June 15, 2021 Alvotech announced that data collection has been completed from the last of its 568 clinical trial study participants in AVT02-GL-302, a switching study for AVT02, the company’s biosimilar to high concentration (100mg/mL) Humira®. The switching study compared the pharmacokinetics, efficacy, safety, and immunogenicity of AVT02 (40…

Read More