Guest Columns

1. Mammalian Biomanufacturing Industry Supply & Demand Trends 11/24/2020

   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.

2. Will Biosimilar Manufacturers Pursue Lower-Revenue Products? 11/10/2020

   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.

3. Interacting With FDA During Biosimilar Development: From Initial Advisory Meeting To BLA 11/3/2020

   In Part 2 of this two-part article, we discuss what information is critical to support the sponsor’s argument that the proposed product is biosimilar to the designated reference product and when is it appropriate and at what level of detail it should be for each stage of interaction with the FDA.

4. Mapping The Development Of A Biosimilar Candidate: Analytical & Regulatory Decisions 10/27/2020

   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.

5. Mammalian Biomanufacturing Industry Supply & Demand Trends 10/26/2020

   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.

6. Federal Circuit To Decide Limits On Functional Claiming Of Isolated Monoclonal Antibodies 10/22/2020

   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. 

7. 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.

8. 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. 

9. 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.

10. 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.