Interchangability Denied To First US Approved Biosimilar

Emily BurkeBiologics, Biomanufacturing, Biosimilars, Business of Biotech, Drug Approvals, FDA, Mechanism of Action, Term of the Week, The WEEKLY

G-CSF: The original Innovator Sandoz’s (Princeton, NJ) Zarzio rode the first wave into the U.S. biosimilars market after it received FDA approval last week. Zarzio is similar to Amgen’s (Thousand Oaks, CA) Neupogen and both of these medications are recombinant versions of the “go to” stimulator for white blood cell production—known as granulocyte-colony stimulating factor (G-CSF). White blood cells (WBC) … Read More

Biosimilars: Ready or Not, Here They Come

Emily BurkeBiologics, Biomanufacturing, Biosimilars, Biotech Basics, Drug Development, Easily Confused, FDA, Small Molecule Drugs, The WEEKLY

Last week, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended Novartis’  biosimilar version of Amgen’s megahit Neupogen (filgrastim), effectively paving the way for the first US biosimilar approval in the near future. Filgrastim is a recombinant version of a naturally-occurring protein which stimulates the bone marrow to increase production of white blood cells. Patients undergoing chemotherapy, as well as those receiving bone marrow … Read More