Here are the top 5 biosimilar articles for the week of December 7, 2020.
Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilar articles for the week of December 7, 2020.
Number 5: A long-term, comparative, phase 3 trial of Celltrion’s CT-P10 vs the rituximab originator (Rituxan) has provided evidence of biosimilar value in follicular lymphoma.
Number 4: A high overall response rate of 93% was observed for patients with immune thrombocytopenic purpura who received a romiplostim biosimilar.
Number 3: The FDA clarified a number of concerns surrounding the appropriate procedures for industry to apply for interchangeability status.
Number 2: A survey by the World Health Organization (WHO) of 20 countries highlights the remaining regulatory challenges facing biosimilar adoption.
Number 1: To spur more biosimilar development and reduce anticompetitive practices, Boehringer Ingelheim argued the FDA could improve its interpretation of the term “strength” in the Biologics Price Competition and Innovation Act (BPCIA).
To read all of these articles and more, visit centerforbiosimilars.com.
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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.