Guest Columns

31. 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.

32. 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.

33. Samsung Bioepis CEO: A COVID-19 Call To Action 5/14/2020

    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.

34. Your Drug Or Mine? Managing Drug Delivery Device Differentiation Hazards 5/13/2020

    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.

35. How Will COVID-19 Impact Biosimilar Trends In The Top 5 European Markets? 5/5/2020

    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.

36. Insulin Under The BPCIA: Opportunities And Obstacles 4/22/2020

    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.

37. 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.

38. 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.

39. 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.

40. 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.