Sandoz's Biosimilar Shows Similarity to Amgen's Neupogen

Regulatory shift reflects maturation of CAR-T field and impacts biopharm manufacturing, development, and discovery.

The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.

The biotech company urges government action to support newborn genome screening, emphasizing the need for rare disease care, testing, and family resources.

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

Lilly expands into genetic medicines with Verve's in vivo gene-editing therapies, aiming to replace chronic cardiovascular treatments with single-dose care.

With more than 100 next-generation biologics set to lose patent exclusivity in the next 15 years, there is widespread agreement that developing biosimilars for these therapies will benefit society as a whole.