Guest Columns

41. 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.

42. 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. 

43. 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.

44. 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. 

45. 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.

46. 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.

47. FDA Releases Guidance On Normal GMP Operations During COVID-19 9/18/2020

    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.

48. 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.

49. End Of The Enbrel Battle: How Amgen Beat Sandoz 9/8/2020

    This case serves as a reminder that sometimes it is impossible to fully evaluate the likelihood of success in biosimilar litigation before the challenge begins.

50. An Update On 2020 U.S. Biosimilars Regulation & Litigation 9/1/2020

    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.