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Humira Biosimilar Price War Update: Should We Be Glad that CVS Health and Express Scripts Are Using Private Label Products to Pop the Gross-to-Net Bubble? (rerun)

Drug Channels

During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. The Humira biosimilar market just took another step forwardbut remains far from its ideal state. As you will see below, CVS Healths formulary actions led to rapid uptake of a low-list-price biosimilar.

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FDA Accepts BLA for Shanghai Henlius Biotech’s and Organon’s HLX14, a Denosumab Biosimilar

Big Molecule Watch

On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). Stay up to date on biosimilar news, applications and approvals in China by following our Big Molecule Watch China blog.

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Leading FDAs policy implementation of the MODERN Labeling Act , the statutory authority allowing FDA to make certain generic drug labeling updates. Since the inception of the program, DPD reportedly met every GDUFA goal date for timely issuance of a CPA. But thats all in the past now.

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May 2024 Newsletter

Safe Biologics

ASCO 2024: ASBM Releases Resource Guide for Cancer Patients on IRA’s Impact on R&D, Access From May 31st – June 4th, the American Society of Clinical Oncology (ASCO) held its Annual Meeting in Chicago, IL. ASBM Discusses Biosimilar Interchangeability and Substitution at Oregon’s St. View the resource guide here.

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Drug Channels News Roundup, September 2024: Inside JNJ’s Gross-to-Net Bubble, Optum Rx’s Private Label Biosimilars, Where Biosimilars Boom, Accumulators vs. Patients, and Steve Collis Retires

Drug Channels

Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. There’s still time to request an invite to the inaugural Drug Channels Leadership Forum. Attendance will be highly limited. We have already begun extending invitations, so apply now to be considered. Click here to view the full agenda.

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When Payers Become Producers: Inside the PBM Private-Labeling Trend

Drug Channels

Benjamin reviews the growing trend of PBMs vertically integrating into the production of biosimilars. The findings shed light on payers' view of biosimilar conpetition, contracting challenges, and other issues. Click here to learn more about MMIT’s Custom Market Research offering for biosimilar manufacturers.

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What’s Behind CVS Health’s Novel Vertical Integration Strategy for Humira Biosimilars (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. CVS Health has finally revealed its strategy for biosimilars of AbbVie’s Humira. Click here to see the original post from September 2023. Here’s the press release: CVS Health Launches Cordavis.