Newsletter | March 3, 2024

03.03.24 -- Samsung Bioepis Initiates Ph. 1 For Keytruda Biosimilar


Trends In FDA FY2023 Inspection-Based Warning Letters

The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23), and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.

Continuous Manufacturing: Many Want It, But Here’s Why Few Have It

In 2023, biomanufacturers showed an increasing interest in continuous manufacturing, but uptake, believe it or not, slowed down. Let’s explore the reasons why with data from BioPlan Associates.

Assessing Cross Contamination Using Layers Of Protection Analysis For Facility And Product Safety

Layers of protection analysis (LOPA) is a risk tool that focuses on the strength of controls that are currently in place and enables a cross-functional team to dive into the ways that the controls may fail. The article outlines the application of LOPA to drug product and facility cross contamination.


Revolution In The EU Pharmaceutical Legislation Ahead

Discover how this revised legislation, which will supersede existing regulations that fostered the availability of safe and effective medicines for the past two decades, is set to impact the industry.

Early Product Characterization De-Risks Biologics Development

The relationship between physicochemical profile and biological activity — and how this affects clinical performance — is key to informed decisions, accelerated development, and risk reduction.

Enhancing Security Of Supply Of Cell Culture Media With Single-Use Bags

Biopharma manufacturers continue to face a challenging supply and demand landscape. Learn how one company secured its single-use bag supply with in-house manufacturing of liquid media bags.


Polpharma Biologics' Investigational Biosimilar Shows PK/PD Comparability To Inflammatory Bowel Disease Blockbuster Entyvio

Samsung Bioepis Initiates Phase 1 Clinical Trial For SB27, Proposed Biosimilar To Keytruda (Pembrolizumab)

Organon Announces HADLIMA (adalimumab-bwwd) Has Been Exclusively Selected By The U.S. Dept Of Veterans Affairs, Replacing HUMIRA On Its National Formulary

Mabwell Publishes The Phase 3 Study Results On Its Denosumab Biosimilar (MW032) In The Journal JAMA Oncology

Sandoz Receives Health Canada Approval For Jubbonti, First & Only Denosumab Biosimilar For Treatment Of Osteoporosis

Coherus Announces U.S. Launch Of UDENYCA ONBODY A Novel & Proprietary State-Of-The-Art Delivery System For Pegfilgrastim-Cbqv

Samsung Bioepis Presents Two Abstracts For SB17, A Proposed Biosimilar To Stelara (Ustekinumab), At The 19th Annual Congress Of ECCO


Enabling The Delivery Of Complex Biologics With Ergonomic Solutions