Guest Columns

31. What To Expect From The FDA During (And After) COVID-19 4/20/2020

    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.

32. Do We Need Comparative Clinical Efficacy Testing For Biosimilars? 4/7/2020

    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.

33. Which Biosimilar Companies Will Thrive In 2025? 3/31/2020

    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.

34. Biosimilar Pipeline Experiencing 12% Annual Growth: A Progress Update 3/26/2020

    This article compares aspects of the biosimilar development pipeline and related market evolution since 2013, including what has and hasn’t changed.

35. Analyzing FDA's Final Q&A Guidance On Transition Biologics 3/12/2020

    For 10 years, the date March 23, 2020 was circled in red on the FDA calendar. On that “transition date,” certain drugs FDA approved under the drug approval statute were “deemed” to have a biologics license instead of a New Drug Application approval. How soon will biosimilars see an impact?

36. The 4 Stages Of Drug Delivery Device Evolution: An Inhaler Case Study 3/11/2020

    To illustrate how delivery device development is evolving in practice, we will use the example of respiratory inhalers. This is a well-established treatment modality, with mature technology solutions available, but one where you can envisage a number of future changes enabled by technology. 

37. Shifting Site Of Care For Infused Drugs: An Opportunity For Biosimilars 3/3/2020

    An emerging target for payers is how IV drugs are distributed to providers and where these products are administered. Site of care strategies can generate cost savings, but they may also create unintended consequences. However, just as biosimilars have disrupted the status quo of the biologics market, they may also find opportunity in impacting how care is delivered.

38. FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers 2/28/2020

    Part two of this series takes a deep dive into the types of drug manufacturers that received warning letters and their locations, including data on how frequently the FDA recommends that firms hire qualified consultants and its request for “independent assessments” in warning letters.
     

39. U.S. Sites Play Surprise Role In FDA’s Drug GMP Warning Letter Report 2/21/2020

    Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.

40. FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark? 2/7/2020

    At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” but there's a lot more to the story.