GUEST COLUMNISTS

  • Mammalian Biomanufacturing Industry Supply & Demand Trends

    While capacity will increase over the next five years, demand for capacity, pandemic aside, will increase at a slightly faster rate, allowing for some short-term loosening of capacity constraints, but after 2024, capacity tightening may occur.

  • Federal Circuit To Decide Limits On Functional Claiming Of Isolated Monoclonal Antibodies

    Can a patent claim millions of different antibodies based on their function alone? Tens of thousands? Hundreds? What if the patent gives a plug-and-play road map to make and evaluate the antibodies through routine testing? Whatever the CAFC’s answer, one thing is sure: It will affect how biologic innovators use functional claiming and whether patentees or challengers are more likely to win future lawsuits in the biologics and biosimilar arena. 

  • Biosimilars: The New World Of Commercialization

    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.

  • Private Equity: A New Pillar For Biosimilar Development?

    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. 

  • Weighing The Potential Of Humira Biosimilars In The U.S. — Expected Winners And Losers

    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.

  • Weighing The Potential Of Humira Biosimilars In The U.S.

    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.

  • FDA Releases Guidance On Normal GMP Operations During COVID-19

    Most FDA guidance on COVID has been associated with tools to combat the pandemic. This new guidance should be read by all drug and biologic manufacturers, whether or not they produce COVID-related products.

BIOSIMILAR WHITE PAPERS

  • Counting DNA Molecule By Molecule

    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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BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

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The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.

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