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
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Duke Publishes Recommendations for Developing CGT Biosimilars
October 9th 2024Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.