The Top 5 Biosimilar Articles for the Week of October 23
Here are the top 5 biosimilar articles for the week of October 23, 2023.
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 October 16, 2023.
Number 5: Continuous innovation is required in various technological aspects to effectively manage the challenges of vast clinical data, according to an article on navigating data integrity for generic drug approvals.
Number 4: Researchers of a literature review found similar safety profiles between biosimilar pegfilgrastim and its reference product (Neulasta) across several phase 1 and phase 3 clinical trials.
Number 3: Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.
Number 2: Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).
Number 1: The FDA approved Celltrion’s Zymfentra (infliximab-dyyb), a novel drug that allows for subcutaneous administration of inflximab.
To read all of these articles and more, visit centerforbiosimilars.com.
Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions
December 2nd 2023A survey explores the experiences of health care providers (HCP) throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in New Zealand in 2022.
IQVIA Highlights Opportunity to Cash In on Biosimilars for Biologics Losing Market Exclusivity
November 29th 2023A report from IQVIA noted that Europe could miss out on €15 billion in cost savings by not having biosimilars for medications about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.
CVS Caremark Switches Up Biosimilar Coverage in 2024
November 27th 2023As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.
Phase 1 Study Finds Comparable PK, PD Parameters in Biosimilar GP40141 vs Reference Romiplostim
November 25th 2023A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.
