Newsletter | January 18, 2024

01.18.24 -- FDA Accepts For Review BLA For A Proposed Biosimilar To Stelara

FEATURED EDITORIAL

WHO’s 6 Principles For An AI Regulatory Framework

In mid-October 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO working group whose members include regulatory authorities, policy makers, and more.

INDUSTRY INSIGHTS

Evaluating The Impact Of Sterilization Methods On Stopper Performances

Review studies for a product aiming to address unmet needs around the development of subcutaneous drug therapies, including methods for sterilization and a human factors evaluation.

From Discovery To Commercial Promise With Philogen’s Dr. Dario Neri

In a recent episode of Business of Biotech, Philogen CEO Dr. Dario Neri sat down to explore his journey from academia to startups, as well as Philogen's own trajectory.

NEWS HEADLINES

FDA Accepts For Review BLA For DMB-3115 Of Dong-A ST, A Proposed Biosimilar To Stelara (Ustekinumab)

STADA And Alvotech Secure Approval For Uzpruvo, Europe’s First Ustekinumab Biosimilar To Stelara

Archimedes Announces Biosimilars First, An Industry-Leading Program To Drive Biosimilar Adoption In 2024

Celltrion Presents Strategic Vision And Growth Plan At The 42nd Annual J.P. Morgan Healthcare Conference

Biosimilars Forum Welcomes Biocon Biologics As Newest Member

SOLUTIONS

Closed Processing Cell Bank Manufacturing Services

West Scientific Insights Lab