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The Top 5 Biosimilars Articles for the Week of April 13
Here are the top 5 biosimilars articles for the week of April 13, 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 biosimilars articles for the week of April 13, 2020.
Number 5: A comparison of the global guidelines shows that the WHO guidance that has impacted the largest patient population is filled with scientific misconceptions, leading to lack of trust in the safety and efficacy of biosimilars developed under this guidance.
Number 4: Oncologist and hematologist, Lee S. Schwartzberg, MD, FACP, describes some important considerations for using biosimilars in clinical practice.
Number 3: With positive phase 1 study results and a manufacturing process that may cut costs significantly, BiosanaPharma hopes its omalizumab biosimilar candidate will have an edge on the worldwide market.
Number 2: NeuClone said phase 1 patient monitoring and blood sampling has been completed for its ustekinumab biosimilar candidate, which is targeted at the $6.6 billion in annual revenue earned by Stelara, a product by Janssen Pharmaceutical Companies.
Number 1: The FDA’s new focus on coronavirus disease 2019 (COVID-19) and the quarantines imposed on much of the developed world have pushed digital and remote marketing of pharmaceutical products into high gear, according to Jamie Peck, managing director of iON.
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.
