A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch
A Possible “Humirageddon:” Perspectives On The EU Biosimilar Launch

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.

  • The Humira Tsunami Cometh: What Can We Expect?
    The Humira Tsunami Cometh: What Can We Expect?

    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.

  • What To Watch For In The Implementation Of FDA’s Biosimilar Action Plan
    What To Watch For In The Implementation Of FDA’s Biosimilar Action Plan

    In July 2018, the FDA unveiled a Biosimilar Action Plan (BAP) intended to “facilitate the efficient development and approval” of biosimilar products. When FDA Commissioner Scott Gottlieb introduced the BAP, he emphasized the importance of building a market for biosimilar products and expressed concern that the market is not yet established.

  • Biosimilar Education: The Elements Of An Effective Strategy
    Biosimilar Education: The Elements Of An Effective Strategy

    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.

  • Off The Beaten Path: 3 Strategies For Improving World-Wide Biosimilar Access
    Off The Beaten Path: 3 Strategies For Improving World-Wide Biosimilar Access

    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.

  • Charting A Biosimilar Course In Low- And Middle-Income Nations
    Charting A Biosimilar Course In Low- And Middle-Income Nations

    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.

  • Could Naïve Patients Be The Key To U.S. Biosimilar Success?
    Could Naïve Patients Be The Key To U.S. Biosimilar Success?

    A decade after the primary negotiations that resulted in the Biologics Price Competition and Innovation Act (BPCIA), it is safe to say the promise of biosimilars is yet to be realized. And as it turns out, perhaps naivety, in a clinical sense, is the solution.

  • How Can We Make FDA’s Biosimilar Action Plan A Game-Changer?
    How Can We Make FDA’s Biosimilar Action Plan A Game-Changer?

    Despite all the FDA’s efforts to increase review time and get products to market more quickly, I remain unconvinced that the BAP will turn around the U.S. market — at least not our current market. So what can we do in the meantime?

  • Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?
    Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?

    In light of increased development and demand for biosimilars, as well as looming patent expiries, biologic developers are racing to release the next blockbuster biologic to replicate the success of past top-performers like Humira, and to prevent biosimilars from cannibalizing their market share.

  • 4 Revelations From The FDA’s Biosimilar Part 15 Hearing
    4 Revelations From The FDA’s Biosimilar Part 15 Hearing

    In addition to laying out some of the concerning themes that came up throughout the hearing, I will unpack some of the FDA’s lines of inquiry which I feel illuminated the agency’s efforts to challenge certain claims for the first time. 

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