BOSTON - March 5, 2015 - Biosimilar approvals in the United States are expected to increase during the next five years, but safety concerns among physicians and the need for greater regulatory clarity concerning therapeutic interchangeability could hinder market uptake, according to a study recently completed by the Tufts Center for the Study of Drug Development.
A new U.S. regulatory pathway, called 351(k), is widely expected to speed the development and marketing of biosimilars, a process that began early this year with the first of nine biosimilars expected to gain approval by 2020, said Joshua Cohen, associate professor at Tufts CSDD and author of the study.
"Biosimilars will increase treatment options and slow the growth in spending on biologics, but lack of familiarity with biosimilars by physicians may hinder their use, as has been the case in Europe, where 17 biosimilars have been approved since 2006," Cohen said.
He added that while new biologics in the same therapeutic class could slow the adoption of biosimilar use, payers in the U.S. will encourage biosimilar prescribing by offering lower patient cost-sharing for biosimilars, compared to originator biologics, much like they do today with generic vs. name brand prescription medicines.
Biosimilars are follow-on, approved biopharmaceuticals that are similar to an existing biologic, with no clinically meaningful difference between the two in terms of safety, purity, and potency.
Other findings from the analysis, reported in the March/April Tufts CSDD Impact Report, released today, include the following:
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.