Biosimilar Regulatory solution center

  1. Biosimilar Policies To Watch As We Approach 2019
    10/18/2018

    I reached out to Biosimilar Development editorial board member Molly Burich of Boehringer Ingelheim for her input on the policies she expects could have the largest positive or negative impact on biosimilars, as well as what progress has been made on the policy front.

  2. The Current State Of U.S. Biosimilar Policies — An Overview
    10/17/2018

    With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilars may offer is intriguing to many policymakers as well as those in the industry. 

  3. A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch
    10/16/2018

    In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.

  4. Internal And External Risks To Biosimilar Companies And The Path Forward
    10/15/2018

    There are many challenges to walk through to truly understand the opportunity, the risks, and the best path forward for biosimilars, but the best thing would be to start by recognizing the external and internal risks that likely every player in the space is facing.

  5. Biosimilar Regulatory Inefficiencies: Would Data Sharing Violate The U.S. Constitution?
    10/11/2018

    One of the regulatory inefficiencies the FDA is trying to address is the current requirement for bridging studies to submit data comparing a biosimilar to a non-U.S. licensed product.

  6. The Humira Biosimilar Tsunami Cometh: What Can We Expect?
    10/9/2018

    In the first segment of this two-part Q&A article, da Silva and Heller share their perspectives on the EU market potential for Humira biosimilars, which markets they expect will be most dynamic from a competition standpoint, and what Humira biosimilar players can learn from previous tumor necrosis factor (TNF) biosimilar launches.

  7. What To Watch For In The Implementation Of FDA’s Biosimilar Action Plan
    10/3/2018

    In July 2018, the FDA unveiled a Biosimilar Action Plan (BAP) intended to “facilitate the efficient development and approval” of biosimilars. This article discusses two significant elements of the BAP.

  8. Biosimilar Education: The Elements Of An Effective Strategy
    9/28/2018

    In this first of what I expect will be several articles, I will lay out one of the current educational gaps I’ve noticed, as well as introduce real educational examples or efforts I’ve encountered (or would like to see more of) that show promising and widely adaptable pathways forward.

  9. Off The Beaten Path: 3 Strategies For Improving World-Wide Biosimilar Access
    9/28/2018

    Low- and middle-income nations naturally demand different approaches, and, there is, of course, still much work to be done to bolster biologics use in these countries. This article continues that discussion, illuminating several specific strategies companies can explore to better reach a wide variety of countries and patients.

  10. Charting A Biosimilar Course In Low- And Middle-Income Nations
    9/26/2018

    Though entering some of these nations will not be for the faint of heart, Iyer believes the solution to these access issues is closer than we realize.