On this episode of Not So Different, we take a look at some of the big stories regarding oncology biosimilars throughout the month of September, including 2 FDA approvals, and the withdrawal of a European application.
This episode is going to take a look at some of the big stories regarding oncology biosimilars throughout the month of September, including 2 FDA approvals, and the withdrawal of a European application.
Show notes
FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar
FDA Approves Celltrion Biosimilar for Avastin, Vegzelma
https://www.centerforbiosimilars.com/view/fda-approves-celltrion-biosimilar-for-avastin-vegzelma
Oncology, Ophthalmology Biosimilars Progress in Europe
https://www.centerforbiosimilars.com/view/oncology-ophthalmology-biosimilars-progress-in-europe
Biosimilars Check-In: Canada Approves Third Etanercept; Prestige Withdraws Trastuzumab Application
Coherus Rep Shares Competition Strategy for Adalimumab, Pegfilgrastim Biosimilars
Policy Harmonization, Clarification Could Aid Biosimilar Uptake Efforts
Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar Development
Dr Ivo Abraham Column: When More May Yield Less—Price Erosion of Biosimilars Following US Market Entry
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although 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.
Part 3: Study Questions Usefulness of Clinical Efficacy Trials for Oncology Biosimilars in Europe
November 16th 2023In part 3 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars® reviews an analysis investigating whether clinical efficacy studies have an impact on prescribing decisions for oncology biosimilars across Europe.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On 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.
Part 1: Oncology Biosimilars Offer Comparable Benefits to Originators at Lower Prices
November 14th 2023In part 1 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars® looks at a retrospective study comparing the clinical benefits, price changes, and uptake associated with oncology biosimilars in China.
Eye on Pharma: Denosumab Biosimilar Data; COA Forms New Committee; IGBA and WHO Collaborate
November 8th 2023Samsung Bioepis releases data for its denosumab biosimilar candidate; the Community Oncology Alliance (COA) forms the Drug Policy and Regulation Committee; the International Generic and Biosimilar Association (IGBA) and the World Health Organization (WHO) collaborate on a new initiative.