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The Top 5 Biosimilar Articles for the Week of August 24
Here are the top 5 biosimilar articles for the week of August 24, 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 24, 2020.
Number 5: The European Commission (EC) has given marketing approval for Samsung Bioepis’ bevacizumab biosimilar, making it the company’s fifth approval for the European market.
Number 4: Intract Pharma believes infliximab can be delivered orally and, in conjunction with Celltrion Group, aims to apply its technology and expertise to make it happen.
Number 3: In what a company spokesman described as a minor setback, Coherus BioSciences has seen its Udenyca pegfilgrastim biosimilar dropped from the 2021 national preferred formulary list for the pharmacy benefit manager (PBM) Express Scripts.
Number 2: Celltrion Healthcare said it will begin testing its denosumab (Prolia) biosimilar in a phase 1 clinical trial in September.
Number 1: 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 Anthony S. Fauci, MD, in a recent town hall meeting.
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.
