Emerging markets, particularly Africa, represent an interesting case study for biosimilars. With a young population of more than 1.3 billion, Africa’s economy is the world's second-fastest growing, and the GDP is expected to grow to 3.9 percent in 2020 and 4.1 percent in 2021, according to the African Development Bank.

A new peer-reviewed paper, armed with the necessary data, aims to carry us into the days of more tailored biosimilar development. Lead author Martin Schiestl discusses the paper’s most important findings and what implications these data will have for biosimilar developers and regulators.

As we continue discussing the role of large comparative efficacy studies in the biosimilar development paradigm, two Covance experts focus more specifically on the near-term clinical challenges companies are likely to face as the biosimilar pipeline diversifies in the next few years.

This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.

There is a lot of speculation around exactly just how this pandemic will impact our own FDA timelines. But whether a drug will get approved several months later than expected is not the core issue on which we should be focused — it’s the consequences these delays or changes in our day-to-day work might have for people with severe and chronic illnesses.

Unless we’re pharmacists ourselves, we rarely get a look into the formulary-building process and what this can mean for biosimilar usage overall. Here, pharmacist Sophia Humphreys of Providence St. Joseph Health shares the ins-and-outs of formulary building and the role pharmacists can play to encourage greater biosimilar usage. 

At the U.S. World Biosimilar Congress, Covance's Joan Meyer highlighted the biggest clinical trial challenges and shared tips on how biosimilar companies can communicate the benefits of comparative efficacy trials for patients and investigators alike.

Time to experiment, time to clinic, and time to market are becoming even more important for developers and manufacturers of biopharmaceuticals. These tools make process development more efficient.

Consider what process development capabilities you have versus what you could possibly gain from working with a CDMO to not only be successful but also improve your chances of getting to market sooner.

As of March 23, 2020, insulin now falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This regulatory shift presents both new opportunities and new obstacles for developers of follow-on insulin products.

Though debate on this topic has been simmering on and off for the past few years, members of the biosimilar industry were approaching the nuances of interchangeability with increased zeal at the U.S. World Biosimilar Congress. Here, one expert tackles the lingering questions surrounding interchangeability and its impact on stakeholders.

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 since 2013, including what has and hasn’t changed.

There is a continued demand for novel, fit-for-purpose immunoassays. It’s important for developers to streamline the selection and potential modification of critical reagents to get 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.

This note compares cell growth and recombinant protein production of multiple Chinese hamster ovary cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.

This app note demonstrates a fed-batch process for a CHO cell line producing a mAb. The results emphasize the importance of an appropriate feeding strategy to optimize 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.

iEnzyme-Linked Immunosorbent Assays (ELISAs) to monitor host cell protein levels are challenging. This article illustrates 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.