In part two of this two-part series, several experts from a DIA panel share additional insights around the types of differentiation biosimilar companies can pursue and its overall impact on product/device selection and the manufacturing process. 

A recent webinar from IQVIA on the biosimilar and “biobetter” landscape provided a great overview of the opportunities for differentiation and the outlook for biobetter development. In part one of this two-part article on differentiation, I’ll share some of my main takeaways from IQVIA’s webinar.

Will biosimilar makers have any motivation to develop biosimilar competitors for biologics earning considerably less in U.S. sales than previous generations? Biosimilar Development decided to do a deeper dive into one of these products, which may represent a broader base of biologic agents beyond autoimmune and oncology agents.

In recent weeks, there have been several reports released on the current state of the U.S. biosimilar market — including IQVIA's "Biosimilars in the U.S. 2020-2024." Overall, there were a few data points from this report I thought were worth singling out and discussing a bit further. 

This article, the first in a two-part series, details the biosimilar development path to identify and evaluate critical quality attributes for both the candidate biosimilar and the reference product, along the regulatory timeline.

Great changes are afoot in the world of biosimilar commercialization. Here, Abraxeolus Consulting manager Edric Engert walks you through his view as to what has been, what has changed, and what the new flexible biosimilar business model of the future will look like.

A recent publication entitled "Approval of Biosimilars: A Review of Unsuccessful Regulatory Filings" revealed the most common manufacturing issues the FDA and EMA flagged in biosimilar applications. Here, the lead author discusses his findings from the past, current manufacturing challenges, and which technologies could be most impactful for the future biosimilar industry.

Droplet Digital polymerase chain reaction (ddPCR™) was developed to provide high-precision, absolute quantification of nucleic acid target sequences with wide-ranging applications for both research and clinical diagnostic applications. ddPCR measures absolute quantities by counting nucleic acid molecules encapsulated in discrete, volumetrically defined water-in-oil droplet partitions. Droplet Digital PCR using Bio-Rad’s QX100™ or QX200™ Droplet Digital PCR system overcomes the previous lack of scalable and practical technologies for digital PCR implementation.

Recombinant adeno-associated virus (AAV) is rapidly becoming the vector of choice for human gene therapy applications due to the ability to achieve prolonged gene expression in a variety of tissues without a significant immune response or toxicity. Large-scale manufacture of AAV vector for clinical trials requires a high degree of sophistication in both process design and lot release assays. Read how ddPCR represents a highly precise method to determine AAV vector genome titers and is not unduly influenced by inefficient amplification or standard curve issues.

The emergence of the biosimilar market represents an interesting opportunity for private equity firms in the global healthcare landscape. Here are the biggest deals from the last two years that suggest there is growing willingness outside of government funding to invest in biosimilar development — especially in emerging markets. 

This is the second article in a two-part series exploring the anticipated competitive landscape for Humira (adalimumab) biosimilars following their U.S. launch in 2023. In this part, we evaluate the potential for individual adalimumab biosimilar products, comparing and contrasting the agents based on a number of important factors, including order of market entry, company resources and reputation, and product characteristics.

Digital PCR is an established nucleic acid (NA) quantification technology, which enhances the broad use of PCR across molecular biology laboratories globally through improved precision and accuracy. Organizations that impact the quality of nucleic acid measurement and testing, adopted digital PCR early on and have since been pioneering its use for improved accuracy and precision in NA measurement. Ultimately, this will positively impact the quality of NA measurements generally and, more specifically, clinical NA testing. Molecular counting of nucleic acid molecules is the next measurement paradigm.

This two-part article series explores the factors differentiating the Humira (adalimumab) biosimilar market from that of infliximab biosimilars, which could lead to stronger uptake of these products in the U.S. In Part 1, we focus on the unique competitive dynamics within the adalimumab biosimilar market.

There have been a few exciting pieces of news and industry movements that are worth noting as we approach fall. I anticipate these topics will continue to come up and/or shape biosimilar conversations in the years ahead. 

Following the launch of The Biosimilars Generation, I sat down with Sandoz's Karine Matteau. In addition to sharing the goals of the educational initiative, she also discussed how biosimilar companies and governments can encourage greater biosimilar buy-in among all stakeholders.

Given originators' actions and the resulting commercialization risks, as well as the inherent technical risks of biosimilar drug development, how can one possibly expect a biosimilar to launch at a 90 percent discount to the brand? Let’s create a hypothetical example that closely mimics the reality biosimilar manufacturers are facing today and discuss how that impacts the discounts they can provide.

Successful chimeric antigen receptor- (CAR-) T cell therapy requires a target antigen that is unique to cancer cells. But what happens when there are no unique antigens? Researchers at Columbia University Medical Center addressed this problem by replacing healthy non-target cells with genetically modified versions lacking the CAR-T cell target (Borot et al., 2019). Their results, published in PNAS, may provide a new avenue for treatment of some types of cancer.

The breadth of digital PCR (dPCR) applications continues to grow and fulfill critical scientific needs. One of the major advantages the technology confers is the ability to count nucleic acid molecules directly, rather than extrapolating quantity based on standard curves as with many other methods. By harmonizing diagnostic procedures on dPCR platforms, the scientific and medical communities can become more coordinated and efficient than ever before.

Presented here are some tips to keep in mind when starting a cell sorting experiment. They will help you to maximize cell viability, separation, and isolation, and set you up for successful downstream applications.

Fluorescence-activated cell sorting is a valuable tool for research, allowing separation of a mixture of cells into distinct populations for analysis. But could the physical forces of sorting stress the cells, altering their behavior and confounding experimental results? Andrä et al. (2020) found that although cell sorting activated p38 MAPK stress signaling, no functional or structural changes were observable. The results indicate that jet-in-air systems such as the Bio‑Rad S3e Cell Sorter do not alter cell behavior.

This article shares some tips to help you avoid buyer’s remorse and make an educated decision about which instrument to purchase. These tips provide you with the tools to make an informed decision when purchasing a cell sorter.

The biopharmaceutical industry has been growing and evolving at a pace that’s hard to match, especially in terms of manufacturing. Understanding what challenges diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.  

This ebook demonstrates process intensification approaches that enable the development and production of high-quality, niche-segment drugs in a more efficient and cost-effective way. 

In this Q&A, HoUng Kim, Head of the Medical and Marketing Division at Celltrion Healthcare, shares the biggest market-related considerations and regulatory challenges facing a biosimilar company exploring both biosimilars and bioinnovative products.

In this Q&A, Carol Lynch, President, U.S. and Head North America for Sandoz, discusses the supply challenges she’s observed in the biologics space throughout the current pandemic and the efforts biosimilar makers should be taking to meet patients’ needs and prepare for future supply disruptions.

The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.

We are at an interesting time in this industry as it relates to biosimilar competition and education. The EU and U.S. are now learning together how to encourage uptake of the curative oncology biosimilars. This raises two questions around what types of data have and will play crucial future roles for improving confidence in your biosimilar.

In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.

There are several changes I have been observing in the broader healthcare space that biosimilar companies must be prepared to consider to promote greater uptake of biosimilars and, in turn, greater cost savings.

In this Q&A, one rheumatologist talks through some of the biggest takeaways he had from a recent Cardinal Health survey and how rheumatologists, manufacturers, and payers can better move the biosimilar industry forward for patients.