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.
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Sustainable Biosimilar Markets Achieve Widespread Market Uptake Through Collective Action
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