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Biosimilars Oncology Roundup for September 2022—Podcast Edition
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
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
Biosimilars in Action: Market Shifts, Legal Insights, and FDA Approvals
February 9th 2025In this episode of Not So Different, host Skylar Jeremias covers the latest biosimilar developments, including new FDA approvals, patent disputes, and biosimilar market trends shaping the health care landscape.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
