Patents are the most important requirement for successful biologic commercialization, yet stakeholders often have little understanding of the unique obstacles encountered in this field, especially for biosimilars. Biologics may treat less than 2 percent of the U.S. population, but they account for 38 percent of all U.S. prescribed drug spending.
Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.
When it comes to biosimilars, building confidence that these medicines can deliver the same experience as a branded medicine will ultimately require more than communicating successful clinical trial results. Here, we unpack several strategies patient advocacy groups have indicated to be essential for successfully reaching patients.
A look at the role real-world evidence (RWE) can play in increasing the uptake of biosimilars in the U.S. market and some of the challenges in leveraging the potential of RWE.
A number of articles already provide a synopsis of the FDA's reversal on the Statistical Approaches draft guidance. But I felt it was necessary to add one more article to this conversation, not only because this action is unprecedented thus far in the biosimilar industry, but it also suggests an important turning point in the FDA’s biosimilar oversight.
Mundipharma expert Richard Trollope shares his learnings from launching three different biosimilar molecules (Remsima, Truxima, and Herzuma) in the EU and discusses the questions that remain about the newly launched Herzuma, recently introduced in the U.K. and Germany.
Thanks to Mundipharma's Richard Trollope, I not only got the inside scoop on what makes a biosimilar partnership specifically a biosimilar partnership, but also Mundipharma’s journey in launching Remsima, Truxima, and, most recently, Herzuma.
An in-depth discussion that explores the recent developments in the U.S. marketplace from both the regulatory and payer viewpoints, with an emphasis on how these may lead to opportunities for biosimilar manufacturers.
A recently published literature review of biosimilar switching studies drew some pushback in the form of a letter to the editor. Though this letter may seem, on the surface, another frustrating bump in the road, it raises several new, important lines of inquiry for biosimilar makers and stakeholders to explore in future publications.
In this first article of a three-part roundtable industry experts share their insights on the status of the market for biosimilars and explore some of the reasons for the difference between the U.S. and Europe.
Trevor Marshall of Zenith Technologies discusses the impact that multi-product manufacturing facilities, single-use technologies, continuous manufacturing and industry 4.0 will have on automation.
Complete transparency and open communication are critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?
Over the life of a drug, changes in raw materials are almost inevitable. But even a small modification can throw your drug out of compliance. Using case studies, the author explains how to safeguard drug integrity when raw materials change.
Flow cytometry introduces a powerful and versatile technology into studies, enabling in-depth analysis of cell signaling and behavior.
An informative presentation focused on the understanding the challenges in virus/VLP purification, choosing the appropriate (or right) chromatography media for the production virus particles, and developing chromatography methods for optimal binding selectivity and recovery of virus particles.
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