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The Top 5 Biosimilar Articles for the Week of September 21
Here are the top 5 biosimilar articles for the week of September 21, 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 September 21, 2020.
Number 5: Expanded indications have been approved for Merck’s Brenzys etanercept biosimilar by Health Canada to include plaque psoriasis, psoriatic arthritis, and juvenile idiopathic arthritis.
Number 4: After receiving positive results from a phase 1 trial for its coronavirus disease 2019 (COVID-19) monoclonal antibody treatment (CT-P59), Celltrion Healthcare has received approval to initiate a phase 2/3 trial.
Number 3: The American College of Physicians (ACP) said many reforms are needed to install appropriate checks and balances in the biologic drugs marketplace.
Number 2: Positive pharmacokinetic (PK) equivalency data were presented for PrestigePharma’s trastuzumab biosimilar candidate, at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Number 1: Much of the groundwork for establishing equivalence is established in the pharmacokinetic evaluation. Further studies add less and less to the body of evidence for biosimilar approval, UK regulators write.
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.
