Guest Columns

  1. EU5 Biosimilar Adoption: What Can The Past Tell Us About The Future? 11/12/2019

    In this article, we review the penetration of biosimilars in the top five EU markets, with special emphasis on the years 2016 and 2018, as well as the key elements that could explain these results. The survey focuses on 23 of the 57 approved products for which we have data from at least 18 months in the five markets.

  2. Will Authorized Biologics Disrupt The Market For Biosimilars? 11/5/2019

    The small molecule generic drug market and the current biologics/biosimilar market are ultimately not directly comparable. However, it's instructive to analyze how authorized generics impact the small molecule space to predict how authorized biologics may impact the biosimilar/interchangeable market in the future.

  3. Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes 10/29/2019

    Once again, Congress has its eyes on the pharmaceutical industry. Legislators from both parties have been active in proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.

  4. Are Good Manufacturing Practices No Longer Good Enough? 10/28/2019

    Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?

  5. Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time 10/22/2019

    In this second part of a two-part series, we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.

  6. Trends To Watch In China’s Biopharma Industry 10/18/2019

    China’s biopharma segment has experienced double-digit growth for the past decade, and the landscape is poised for robust growth for the near future. The country's biopharma sales are on track to reach over $50 billion. Here's why that matters to you.

  7. Intro To Prefilled Syringe Selection: Staked-In Needles 10/15/2019

    This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts. 

  8. The Need For Enhanced Control Strategies In Biopharma Production 10/15/2019

    Biologicals are the next great step for the pharmaceutical industries. The double-edged sword is that, as the molecules become more and more complex, our need for control and understanding becomes greater. 

  9. Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook 10/8/2019

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

  10. New Bill Aims To Drive Insulin Price Reductions 10/1/2019

    The Insulin Price Reduction Act (IPRA) proposes to drive price reductions by drug companies by providing them with incentives to roll back the list price of insulin products to 2006 levels. Specifically, IPRA would make it illegal for pharmacy benefit managers (PBMs) and insurers to recover rebates from manufacturers that reduce the prices they charge wholesalers for insulin to those 2006 levels.