News

Four recent studies investigated the proposed etanercept biosimilars SB4, LBEC0101, CHS-0214, and GP2015.
In an effort to better address the needs of patients taking reference etanercept (Enbrel), Amgen has launched an ergonomically designed cartridge with a reusable auto-injector in the United States as an additional administration option.
The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of November 13.
A new CMS proposed rule seeks to encourage the use of lower-cost biosimilars instead of reference biologics under Medicare Part D. The proposed rule would modify the definition of generic drugs—for the purposes of non–low-income-subsidy (LIS) catastrophic and LIS cost-sharing—to include biosimilar therapies.
In a Thursday session of the SMi Biosimilars North America 2017 conference, Cindy Cao, PhD, executive director and head of United States regulatory affairs at Sandoz, looked ahead to the advent of interchangeable biosimilars.
Australian researchers Kellie A. Mouchemore, PhD, and colleagues urge caution in the use of granulocyte colony stimulating factor (G-CSF) in neutrophil recovery following chemotherapy for breast cancer because there is increasing evidence that G-CSF can promote metastasis.
Mkaya Mwamburi, MD, PhD, MA, president and CEO of the biotechnology consulting firm profecyINTEL, said in a presentation at the 2017 SMi Biosimilar North America conference that manufacturers of originator biologics are taking the lead on biosimilar development.
In a Wednesday session of the SMi Biosimilars North America 2017 conference, Gary Cupit, PharmD, senior advisor to the investment bank Frontcourt Group, gave biosimilar manufacturers his perspective on the market access challenges facing biosimilar developers.
Steinar Madsen, MD, medical director of the Norwegian Medicines Agency, shared lessons learned from the Norwegian experience with biosimilars in a Wednesday talk at the SMi Biosimilars North America conference.
At a Wednesday session of the SMi Biosimilars North America conference, Chrys Kokino, MBA, head of Mylan’s global biologics commercial division, said that biosimilars can be part of improving access to and affordability of biologic therapies for patients worldwide, but also highlighted the hurdles that biosimilar developers will have to overcome as they seek to gain a foothold in the US marketplace.


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