Here are the top 5 biosimilar articles for the week of August 17, 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 August 17, 2020.
Number 5: Allowing pharmacists to independently fill prescriptions with biosimilars can offer community oncology practices a way to cut costs and increase access to cancer care for patients, according to Lucy Langer, MD, practice president and chair of the National Policy Executive Committee for The US Oncology Network.
Number 4: Much has been made of treatments for advanced coronavirus disease 2019 (COVID-19) infection, but early-stage treatments such as monoclonal antibodies (mAbs) and direct-acting antivirals (DAAs) are showing promise, said [Dr] Anthony S. Fauci, MD, director of the National Institute of Allergy and Infection Diseases, in a recent town hall meeting.
Number 3: Biosimilars for the top 10 biologics by revenue have yet to achieve more than a toehold in the United States, which represents a huge missed opportunity for employers, according to Juliana Reed, MS, a vice president and Global Corporate Affairs lead for Pfizer.
Number 2: Employers asserting their own desire to see biosimilars implemented among their employees was the theme of a Pacific Coast day of discussions involving representatives from Walt Disney, Costco, and the California Public Employees’ Retirement System (CalPERS).
Number 1: Celltrion Healthcare finds fault with a critique of equivalence margins used to approve its infliximab biosimilar CT-P13 (Remsima, Inflectra).
To read all of these articles and more, visit centerforbiosimilars.com.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.