Business

Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars

January 11th 2024

By Skylar Jeremias

As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.

CVS to Remove Humira From Some Reimbursement Lists in Favor of Biosimilar Options

January 6th 2024

Starting April 1, 2024, Hyrimoz and an unbranded version of Humira manufactured by Sandoz will be covered across all CVS formularies.

Developers’ Perspective on Streamlining the Biosimilar Development Process

January 2nd 2024

By Deana Ferreri, PhD

The regulatory structure of biosimilar development can be safely streamlined and made more efficient and less costly, wrote authors from Sandoz, Fresenius Kabi, Boehringer Ingelheim, and Samsung Bioepis in an opinion article published in BioDrugs.

Eye on Pharma: Bevacizumab Update; Samsung Bioepis, J&J Settlement; Another EU Trastuzumab

December 6th 2023

By Skylar Jeremias

Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.

HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain

November 28th 2023

By Skylar Jeremias

Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.

CVS Caremark Switches Up Biosimilar Coverage in 2024

November 27th 2023

By Denise Myshko

As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.

Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar

November 22nd 2023

By Skylar Jeremias

Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).

Webinar: Where Do Biosimilars Fit Into the Cancer Treatment Puzzle?

November 16th 2023

In partnership with The Center for Biosimilars®, the International Generic and Biosimilar Association hosted a live webinar, where panelists gathered from around the globe to discuss benefits as well as major barriers and accessibility challenges associated with oncology biosimilars worldwide.

Biosimilar Business Roundup for October 2023—Podcast Edition

November 5th 2023

By Skylar Jeremias

On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.

Biosimilars Business Roundup: October 2023

November 1st 2023

By Skylar Jeremias

Between 3 regulatory approvals, 2 complete response letters, and new data and industry insights, October brought a number of business updates that have the potential to impact the entire US biosimilar industry.