GUEST COLUMNISTS

• Samsung Bioepis CEO: A COVID-19 Call To Action

  There is a lot of speculation around exactly just how this pandemic will impact our own FDA timelines. But whether a drug will get approved several months later than expected is not the core issue on which we should be focused — it’s the consequences these delays or changes in our day-to-day work might have for people with severe and chronic illnesses.

• Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards

  To ensure that patients receive the correct product and medication dosage and to minimize the potential for medication error, drug delivery devices must be designed both to be differentiable from similar products and also to facilitate distinguishability between varying doses of the same medication.

• How Will COVID-19 Impact Biosimilar Trends In The Top 5 European Markets?

  It is undeniable that COVID-19 will have a significant impact on biosimilar uptake, particularly in European markets in which governments cover citizens' pharmaceutical needs and where the crisis will lead to an important reduction of available resources. However, it is difficult to assess the extent to which this will occur.

• Insulin Under The BPCIA: Opportunities And Obstacles

  As of March 23, 2020, insulin now falls under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This regulatory shift presents both new opportunities and new obstacles for developers of follow-on insulin products.

• What To Expect From The FDA During (And After) COVID-19

  More than 100 non-COVID-19 trials have been put on hold, and only 14 percent of sites are open for enrollment. This dynamic forces an evaluation of the regulatory impacts our industry faces in the wake of COVID-19 and what to expect in the months ahead.

• Do We Need Comparative Clinical Efficacy Testing For Biosimilars?

  This article examines the nature of comparative efficacy testing and suggests that these studies may be providing misleading evidence of safety and efficacy of biosimilars and should be replaced with more objective pharmacokinetic studies.

• Which Biosimilar Companies Will Thrive In 2025?

  Five years after the first biosimilar was made available for prescription in the U.S., the American biosimilar market may be turning a corner on the road to sustainability.