Guest Columns

11. 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.

12. 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.

13. 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.

14. 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.

15. Janssen v. Celltrion Federal Circuit Judgment: What Biosimilar Makers Need To Know 8/25/2020

    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.

16. Genentech v. Amgen Federal Circuit Judgment: What Did We Learn? 8/18/2020

    The Federal Circuit recently issued Rule 36 judgments in two separate BPCIA cases: Genentech v. Amgen and Janssen v. Celltrion. Because the Federal Circuit decided both appeals without opinion, several open questions remain unresolved regarding BPCIA litigation. This two-part article explores those questions, starting with Genentech v. Amgen.

17. CBER Takes On More Oversight Of Biologic Biosimilar Master Files 8/11/2020

    For a new biologic product applying for marketing authorization under a biologics license application (BLA), the drug master file (DMF) may be utilized for raw materials, starting materials, and packaging materials, but not for drug substance, drug substance intermediate, or drug product, for reasons that will be discussed in this article.

18. COVID-19’s Impact On Bioprocessing: Insights From Industry Leaders 8/5/2020

    We interviewed 26 biopharma senior executives regarding how they are handling the crisis and its long-term impact on their operations. We found the pandemic has begun to catalyze and accelerate a number of significant changes, including many preexisting trends.

19. 3 Healthcare Changes Biosimilar Companies Must Prepare For 8/4/2020

    There are several changes I have been observing in the broader healthcare space that biosimilar companies must be prepared to consider to promote greater uptake of biosimilars and, in turn, greater cost savings.

20. The Case For Optimism In The U.S. Biosimilar Market 7/28/2020

    In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next five to 10 years. In this op-ed, Amgen's Chad Pettit shares why the U.S. has cause to be optimistic about the competition emerging in the U.S.