The first wave of Stelara (ustekinumab) biosimilars show steep Wholesale Acquisition Cost discounts greater than 80%, the ...

Chime Biologics, a leading global CDMO that enables its partners’ success in biologics, announced a strategic cooperation agreement with Polpharma Biologics to advance the end-to-end development and ...

Generic drugmaker Viatris has become the first company to secure FDA approval for a biosimilar ... but that was approved as under a new drug application, not as a biosimilar, and so also needs ...

Analytical laboratory testing plays a pivotal role in every stage of drug development and manufacturing. From route design and optimization to clinical trials and ultimately the finished product, ...

The US FDA has approved ... The importance of biosimilars only continues to grow, driven by the potential savings they are able to deliver to healthcare systems. In a new pharmaphorum podcast ...

AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic ...

“We are excited to welcome Rob as the new ... a single FDA approval.” “I am excited to join the AEON team and work towards delivering on ABP-450’s tremendous potential as a biosimilar ...

Sophia Humphreys, PharmD, MHA, BCBBS, emphasized that legislative support and formulary changes are crucial for overcoming ...

This policy document proposes an update to the Biologics Price Competition and Innovation Act (BPCIA) of 2009, recommending that the U.S. Food and Drug Administration (FDA) adopt a tailored clinical ...