Guest Columns

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

   This year saw a significant change in the process for submitting drug master files (DMFs) for biologic products: as of March 23, biologic-related DMFs are now administered by the FDA’s Center for Biologics Evaluation and Research (CBER). This transition of responsibilities presents a number of challenges for sponsors accustomed to working under the Center for Drug Evaluation and Research ( CDER).

2. 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.

3. 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.

4. 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. 

5. 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!

6. 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.

7. 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.

8. 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.

9. A New Guide For Promotional Labeling And Advertising Of Biosimilar Products 5/26/2020

   This article will outline the central components of new FDA guidance on promotional labeling and advertising considerations for biological reference and biosimilar products. While such materials are overseen by the FDA, the article also explores an alternative method of challenging claims of misinformation and other forms of unfair competition that may impact the biosimilar space moving forward.

10. Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing? 5/19/2020

    This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.