Guest Columns

  1. Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise 5/5/2021

    With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.

  2. Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare 5/5/2021

    The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.

  3. FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities 5/3/2021

    On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.

  4. No, Biologics Are Not Natural Monopolies 4/28/2021

    Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.

  5. Making Sense Of Antibody Epitope Claims 4/16/2021

    Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent. 

  6. Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across 3/31/2021

    Biosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.

  7. Assessing CT-P13 SC’s Impact Across Indications 3/24/2021

    This is the second article in a two-part series exploring the anticipated competitive dynamics for Celltrion’s subcutaneous (SC) infliximab bio-better, CT-P13 SC, in the U.S.The author explores how market dynamics across different autoimmune indications will drive distinct uptake of CT-P13 SC, highlighting the potential impact on TNF inhibitor competition.

  8. Subcutaneous Infliximab In The U.S.: Defining CT-P13 SC’s Competitive Edge 3/17/2021

    TNF inhibiting biologics still reign supreme when treating immunological diseases. GlobalData believes that Celltrion’s CT-P13 SC will likely see better success than IV infliximab biosimilars in the U.S. In Part 1 of this two-part article series, we assess the factors that may give CT-P13 SC a competitive edge over Remicade and IV infliximab biosimilars.

  9. Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021 3/8/2021

    This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020 transition date, as well as FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic. 

  10. Changing Perceptions On Bioprocess Intensification, Continuous Processing 3/1/2021

    Process intensification and continuous bioprocessing are concepts with inconsistent definitions. What's included often varies greatly and, in some ways, has become more about aspirational goal-setting than actual innovation adoption. Here, BioPlan Associates assesses the changing perspectives of 122 bioprocess decision-makers.