GUEST COLUMNISTS

  • Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers
    Drug Coupons: An Ongoing Debate Between States, Payers, And Manufacturers

    The clock is ticking for state lawmakers to preserve an existing law that allows for prescription drug coupon usage in Massachusetts with an end-of-the-year deadline fast approaching.

  • Can The FDA Salvage Interchangeable Follow-On Biologics?
    Can The FDA Salvage Interchangeable Follow-On Biologics?

    Learn the statutory and regulatory requirements for interchangeability designation, how the designation hampers follow-on biologics, and why the FDA should loosen requirements for the designation.

  • EU5 Biosimilar Adoption: What Can The Past Tell Us About The Future?
    EU5 Biosimilar Adoption: What Can The Past Tell Us About The Future?

    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.

  • Will Authorized Biologics Disrupt The Market For Biosimilars?
    Will Authorized Biologics Disrupt The Market For Biosimilars?

    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.

  • Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes
    Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes

    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.

  • Are Good Manufacturing Practices No Longer Good Enough?
    Are Good Manufacturing Practices No Longer Good Enough?

    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?

  • Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time
    Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time

    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.

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BIOSIMILAR WHITE PAPERS

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BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

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Biosimilar approvals in the U.S. are being granted at a quicker pace, but the allure of tailored biosimilar development that lowers or eliminates dependence on large comparative clinical trials remains a long-term, highly sought-after goal. This free collection of articles examines several of the FDA’s most recent high-profile guidances and how certain regulatory decisions will (or will not) advance the biosimilar industry.

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LIFE SCIENCE EVENTS

Effective Batch Record Review – Getting It Right The First Time January 8 - 8, 2020
1:00pm - 2:30pm EST, Online Training
Clinical Research Project Management - 7 Breakthrough Behaviors For Success January 14 - 14, 2020
1pm-2:30pm EDT, Online Training
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error January 15 - 15, 2020
1pm-2:30pm EST, Online Training
Specialty Therapies and Biosimilars Summit January 22 - 24, 2020
Miami, FL
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