Here are the top 5 biosimilar articles for the week of October 16, 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: No safety or immunogenicity differences were found in patients who switched to a biosimilar and those who continued on a reference biologic or biosimilar.
Number 4: An international comparative analysis found that the level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.
Number 3: Prince Edward Island became the eleventh jurisdiction in Canada to implement a biosimilar transition policy, in which patients who are currently taking select reference agents will transition to biosimilar versions.
Number 2: Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.
Number 1: Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.
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.