The Most-Read Contributor Articles of 2019

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.

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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.

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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.

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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.”

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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.