In 2019, readers of The Center for Biosimilars® gravitated toward content reflecting the future of the market. Contributors from Amgen and Coherus BioSciences drew in readers with their assessments of new developments and practices to increase savings for patients, while other contributors took a look at how FDA guidelines will impact biosimilars.
In 2019, readers of The Center for Biosimilars® gravitated toward content reflecting the future of the market. Contributors from Amgen and Coherus BioSciences drew in readers with their assessments of new developments and practices to increase savings for patients, while other contributors took a look at how FDA guidelines will impact biosimilars.
5. Safety and Scientific Standards First: Why Biosimilars Require Clinical Testing
In this article, author Gary Fanjiang, MD, MBA, MS, vice president of global development at Amgen, explains his view that analytical data alone is not “sufficient to demonstrate biosimilarity,” and that clinical testing must be carried out to fully evaluate new potential products. Highlighting the differences between a biosimilar and its reference product, the author stresses how useful comparative clinical testing can be. Fanjiang refutes the notion that clinical testing slows innovation while arguing that it boosts confidence in the regulatory approval process of biosimilars.
Read the full article here.
4. Biosimilars Access: It’s Time to Choose
Jim Hassard, MBA, claims that increasing biosimilar access and allowing patients to choose treatments is of paramount importance when it comes to ensuring the most beneficial outcomes. Hassard, the senior vice president of Coherus BioSciences, emphasizes that his company prides itself on its decision to seek “parity insurance coverage with originator biologics, giving doctors and patients the freedom to make the right decision for them.” Ending anticompetitive rebate agreements and granting patients access to lower-costing biosimilars is essential to creating extensive investment and development in the field, according to Hassard.
Read the full article here.
3. 2019: The Year that Interchangeability Might Chance the Biosimilars Landscape
As biosimilar manufacturers and other stakeholders aim to reduce costs and increase product uptake, a focus on interchangeability in the biosimilar landscape will follow, according to authors George C. Yu, JD, and Christopher Bruno, JD. FDA guidance on seeking interchangeability should ideally streamline regulatory pathways for biosimilars and create structured scientific criteria. However, “because no biosimilar products approved for marketing have yet been designated as interchangeable, biosimilar companies looking to establish interchangeability do not have a model to replicate,” according to the authors.
Read the full article here.
2. A Critical Analysis of the FDA Draft Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations
New draft guidelines from the FDA regarding the analytical testing of biosimilars to a reference product was released in June 2018. In this article, Author Sarfaraz K. Niazi, PhD, reviews the essential elements of the guidelines and identifies new features. In addition, the author outlines what he sees as deficiencies that may hinder faster development of biosimilars. Niazi states, “The new analytical assessment guidance, intended to replace the withdrawn guidance, provides clarification of several practices, yet leaves out many specifics for the sponsors to interpret.”
Read the full article here.
1. Biosimilars Market is Ripe for Cost Savings
Chad Pettit, MBA, the executive director of global value access and policy for Amgen’s biosimilars business unit, relays that the company is committed to delivering protentional savings on biosimilar products in the most-read contributor article of 2019. According to the IQVIA Institute for Human Data Science, projected annual savings resulting from biosimilar products could reach $60 billion in 2023. Pettit explains, “As a manufacturer of originator biologic products as well as biosimilars, we know that there’s no need for government policies to force prescribing of biosimilars,” adding that head-to-head competition between biosimilars can generate savings.
Read the full article here.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Eye on Pharma: BI Cyltezo Partnership; Europe Ustekinumab Launch; Mexico Biosimilar Approval
July 24th 2024Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Real-World Study: No Increase in Health Resource Costs After Infliximab Biosimilar Introduction
July 20th 2024Although biosimilars reduce drug purchasing costs for hospitals, it’s unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative.