Newsletter | March 21, 2024

03.21.24 -- Biosimilars Forum Urges Congress To Reform PBMs


In this presentation from the February 2024 OPCU event, Mabion, a biologics CDMO with end-to-end services focusing on recombinant proteins development and production, showcases their new installations in upstream development, bioreactors, and downstream development and fill/finish. This state-of-the-art EU-GMP-certified facility is staffed by a team of 250 professionals and as of 2023 is focused solely on providing CDMO services to its clients. Watch now.


Risk And Supply Chain Continuity Management: Biologics Industry Perspectives

We spoke to three long-standing members of BioPhorum’s Risk and Business Continuity Workstream about their companies’ approaches to risk management, supply chain continuity, and what they learned from the pandemic. Among them are Melinda McCants, senior resiliency officer at Amgen.

How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing

To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts. 

Green Gains In Biopharma Without Closing Facilities?

Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.


Development And Regulation Of Veterinary Monoclonals

Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

Regulatory Considerations For Alternative Microbial Methods

We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.

Biopharma Manufacturing For Advanced Therapies: A Panel Discussion

Explore highlights from a panel discussion focused on improving biomanufacturing processes to help ensure the next generation of advanced therapies is both accessible and affordable to patients.


Celltrion USA Completes Submission Of Biologics License Application (BLA) To U.S. FDA For CT-P39, An Interchangeable Biosimilar Candidate Of XOLAIR (omalizumab)

Biosimilars Forum Urges Congress To Support Free Market Competition & Lower Prescription Drug Prices For Patients By Reforming Pharmacy Benefit Managers

Sandoz Receives FDA Approval For First & Only Denosumab Biosimilars

Phase 3 Clinical Trial Completed In China For Boan Biotech’s Dulaglutide Injection BA5101. BLA To Be Filed Soon

Samsung Bioepis Presents Two Abstracts For Its Immunology Portfolio At The 2024 AAD Annual Meeting


Modeling Platform To De-Risk Container-Closure Selection