This article examines the nature of comparative efficacy testing and suggests that these studies may be providing misleading evidence of safety and efficacy of biosimilars and should be replaced with more objective pharmacokinetic studies.

During our conversation, Pontchartrain Cancer Center COO Kathy Oubre shared what biosimilar makers can do to balance both sustainability and promote cost savings while also supporting cancer centers and their healthcare professionals.

Five years after the first biosimilar was made available for prescription in the U.S., the American biosimilar market may be turning a corner on the road to sustainability.

This article compares aspects of the biosimilar development pipeline and related market evolution over the past seven years, since 2013, including what has and hasn’t changed.

There is a continued demand for novel, fit-for-purpose immunoassays. Despite the challenges, it’s important for assay developers to streamline the selection and potential modification of critical reagents to get their tests to market quicker.

An emerging target for payers is how IV drugs are distributed to providers and where these products are administered. Site of care strategies can generate cost savings, but they may also create unintended consequences. However, just as biosimilars have disrupted the status quo of the biologics market, they may also find opportunity in impacting how care is delivered.

Efficient monitoring of T cell surface markers, cytokines, and expression patterns is critical to the study of immunotherapies. Learn how the Ze5 Cell Analyzer enables you to test these multiple parameters simultaneously.

One oncology expert shares his thoughts on the operational challenges biosimilars may pose hospitals and what biosimilar manufacturers need to consider as they continue to invest in and launch oncology biosimilars.

The most widely used cell lines for biopharmaceutical production of therapeutic proteins originate from CHO cells. These cells are robust in culture and are able to produce a variety of recombinant glycoproteins at high levels in large scales. This application note compares cell growth and recombinant protein production of multiple Chinese hamster ovary (CHO) cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.

ActiPro cell culture production medium is intended to be used in combination with Cell Boost 7a and 7b supplements to enhance recombinant protein production in fed-batch or perfusion processes. This work demonstrates the development of a fed-batch process for a CHO cell line producing a monoclonal antibody (mAb). The results emphasize the importance of an appropriate feeding strategy to achieve optimal cell growth and productivity.

When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. So how can this process improvement be performed reliably? It makes sense to use a Design of Experiments (DoE) and empirical approach. Here is an example of how to do it.

The most widely used and accepted method to monitor host cell protein levels in biologics is an immunological assay, Enzyme-Linked Immunosorbent Assay, also known as ELISA. However, this coverage assay comes with some known challenges. Learn more about an enhanced anti-host cell protein antibody coverage analysis method solution.

In this first of a two-part article based on our discussion, a payer and employer coalition director highlight some of the payer and employer-centric discussions that are being had today to both improve biosimilar access and navigate a system that has not been friendly to lower-cost competition thus far.

Kaiser Permanente's Dr. Sameer Awsare and I touched base in recent weeks to talk about the process in place that has encouraged great success for biosimilars within KP. In particular, Dr. Awsare reinforces many of the lessons I’ve heard from other physicians within different healthcare settings in order to encourage greater physician and patient biosimilar buy-in.

ÄKTA go is a small and compact liquid chromatography system that allows researchers to perform routine protein purification with ease while allowing for efficient use of bench and cold cabinet space.

Epitope binning immunoassays using surface plasmon resonance (SPR) can and should be deployed in the development of new potential drug candidates. This article discusses how SPR is used to characterize closely related “bins” of mAbs targeting the same epitope of the target protein and how the selection process is used to develop new vaccines, therapeutic antibodies, and diagnostic tools.

Seeing as Sheldon has been in oncology care for almost 40 years and still works as an oncology nurse practitioner, she was the perfect person to speak to about the trends she’s observing in oncology care, in addition to the current role biosimilars play — and could still play — in oncology.

This is the second article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding Biosimilars Price Competition and Innovation Act district court litigation and reviewed ongoing BPCIA district court cases. In Part 2, we turn our attention to BPCIA district court cases that were settled in 2019.

Biosimilars Price Competition and Innovation Act (BPCIA) litigants and Federal and district courts grappled with new issues in 2019. In Part 1 of this article series, we summarize BPCIA district court litigation and review ongoing court cases.

I had the fortune of talking with two U.S. Sandoz executives, Sheila Frame, VP, marketing, market access, and patient services, and William Yoon, head, external engagement and medical advocacy. In the first of this two-part article, I picked their brains about the progress they’ve observed and how challenges for the industry have evolved over the past 10 years.

Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.

Following the news of Fresenius Kabi’s new biosimilar R&D lab, I reached out to one executive to discuss the current challenges in biosimilar R&D, including maintaining the delicate balance between biosimilar R&D and commercial teams as Fresenius Kabi prepares for a long future in the biosimilar space.

I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through. So, you’re getting a whopping seven this year.

As we face 2020, several big questions remain from the past year and about what the future may (or may not) bring for the industry. Here, these 19 experts pose their biggest questions for the new year, as well as how they anticipate or hope these questions could be answered.

The industry has shown surprising resilience and consistency, emerging relatively unscathed from the recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and a recession-resistant risk profile.

As we close out another year of global biosimilar successes and twists and turns, it’s always important to take stock on just how far we have come and where we still hope to go as an industry. As in years past, I reached out to members of Biosimilar Development’s editorial board and several other experts to get their take on the past year's progress.

Overall, there are three broad takeaways to both celebrate and consider about the FDA’s latest clarification of the biosimilar regulatory pathway as it relates to insulin biosimilars.

Here, IQVIA’s Jaclyn Bosco, Sandoz’s Edward Li, and the University of Messina’s Dr. Gianluca Trifirò discuss how RWE can impact regulator and payer decisions, shape treatment pathways, and encourage greater stakeholder comfort and action toward biosimilars.

Though these experts all believe this transition should go off without a hitch and will not hinder insulin access, there are several overarching regulatory and educational considerations the industry should be aware of as March continues to creep closer.

In addition to discussing past challenges, two experts from NeuClone shared insights into the critical analytical, manufacturing, and clinical considerations that are important to make for any company — but especially for smaller companies — when developing biosimilars.