Guest Columns

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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. 

  7. 5 Operational Priorities For Pharmas In The Wake Of COVID-19 7/20/2020

    Consider Gilead’s ramp-up of remdesivir under FDA Emergency Use Authorization, or the efforts of companies racing to bring vaccines and therapeutics for COVID-19 through clinical development, safety and efficacy trials at speeds not seen before. The analogy of changing a tire while driving the vehicle is well known — now picture doing so at 7,000 rpm!

  8. Maybe Biosimilar Applicants Should Dance After All 6/30/2020

    The decision to engage in the BPCIA patent dance with a reference product sponsor is rarely black and white. Early dismissals in cases like Eagle v. Slayback and Amgen v. Coherus are just one factor a biosimilar applicant should consider.

  9. Old Drug, New Tricks: Will The BPCIA Drive Generic Competition For Insulins? 6/23/2020

    High demand, few suppliers, and soaring prices point to the need for more generic competition in the insulin market. This article discusses recent changes to the legal and regulatory framework governing insulin approval that might facilitate such entry.

  10. Africa’s Biosimilar Landscape: Outlook & Current Challenges 6/2/2020

    Emerging markets, particularly Africa, represent an interesting case study for biosimilars. With a young population of more than 1.3 billion, Africa’s economy is the world's second-fastest growing, and the GDP is expected to grow to 3.9 percent in 2020 and 4.1 percent in 2021, according to the African Development Bank.