Biosimilar Development solution center
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Biosimilars: The New World Of Commercialization
10/20/2020
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.
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The Past, Present, & Future of Biosimilar Manufacturing
10/14/2020
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.
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Droplet Digital PCR Applications Guide
10/13/2020
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.
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Private Equity: A New Pillar For Biosimilar Development?
10/13/2020
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.
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Weighing The Potential Of Humira Biosimilars In The U.S. — Expected Winners And Losers
10/6/2020
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.
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Counting DNA Molecule By Molecule
10/1/2020
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.
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Weighing The Potential Of Humira Biosimilars In The U.S.
9/29/2020
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.
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Biosimilar News You May Have Missed During COVID-19
9/21/2020
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.
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Sandoz: Critical Initiatives For The New Canadian “Biosimilars Generation”
9/16/2020
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.
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Expectations Vs. Reality: The Financial Impact Of Market Delays On Biosimilars
9/15/2020
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.