GUEST COLUMNISTS

• 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. — Competitive Dynamics Analysis

  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.

• Expectations Vs. Reality: The Financial Impact Of Market Delays On Biosimilars

  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.

• End Of The Enbrel Battle: How Amgen Beat Sandoz

  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.

• An Update On 2020 U.S. Biosimilars Regulation & Litigation

  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.

• Janssen v. Celltrion Federal Circuit Judgment: What Biosimilar Makers Need To Know

  The Federal Circuit recently issued Rule 36 judgments in two separate BPCIA cases: Genentech v. Amgen and Janssen v. Celltrion. This two-part article series explores some of the unanswered questions raised in these two cases. In Part 1, Genentech v. Amgen was discussed. Here, Part 2 delves into the remaining questions following Janssen v. Celltrion.