A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief
A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief

This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.

  • Biosimilars Conquer Factual Hurdle, Now Face “Emotional Hurdle”
    Biosimilars Conquer Factual Hurdle, Now Face “Emotional Hurdle”

    Conversations about biosimilars amongst stakeholders are beginning to shift in the way that we’d like them to. The industry no longer needs to (stringently) justify the science so much as provide information on how the product can be used. One expert shares some recent revelations she plans to turn into actionable strategies in her role at Mylan and with Medicines for EU.

  • Innovators' Next-Gen Strategy: Is Obsolescence The Best Biosimilar Defense?
    Innovators' Next-Gen Strategy: Is Obsolescence The Best Biosimilar Defense?

    As biosimilars are targeting drugs with more than $5 billion in annual revenue, the originator manufacturers desperately need to find ways to either defend or replace that revenue. Strategies have included portfolio contracting, rebating, patent pursuits, supply chain differentiation, licensing deals, and building customer loyalty.

  • The Search For Biosimilar Value: The Devil Is In The Details
    The Search For Biosimilar Value: The Devil Is In The Details

    In many situations, value is associated with the price tag, and, specifically, the savings associated with a certain product. But there are still questions of how biosimilar value can be presented to stakeholders, especially since it can feel as though there is a missing part in the equation.

     

  • Patentable Subject Matter Barriers For Biosimilars — And How To Overcome Them
    Patentable Subject Matter Barriers For Biosimilars — And How To Overcome Them

    Patents are the most important requirement for successful biologic commercialization, yet stakeholders often have little understanding of the unique obstacles encountered in this field, especially for biosimilars. Biologics may treat less than 2 percent of the U.S. population, but they account for 38 percent  of all U.S. prescribed drug spending.

  • What To Watch In The Biosimilar Regulatory Space
    What To Watch In The Biosimilar Regulatory Space

    Though none of the regulatory issues discussed will be resolved right away, you can guarantee these will become regular parts of the dialogue between the industry and regulators in the years ahead.

  • How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often
    How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

    The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. 

  • EU Turns Focus To Biosimilar Sustainability Questions
    EU Turns Focus To Biosimilar Sustainability Questions

    As Julie Maréchal-Jamil of Medicines for Europe shared, the biggest questions in Europe now circle around sustainability — particularly whether market policies, procurement mechanisms, and benefit sharing models are in sync with the system's needs, and if they can teach nations that have yet to seize the biosimilar opportunity.

  • Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs
    Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs

    Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.

  • Working With Patient Groups To Strengthen Biosimilar Understanding In The U.S.
    Working With Patient Groups To Strengthen Biosimilar Understanding In The U.S.

    When it comes to biosimilars, building confidence that these medicines can deliver the same experience as a branded medicine will ultimately require more than communicating successful clinical trial results. Here, we unpack several strategies patient advocacy groups have indicated to be essential for successfully reaching patients.

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1:00 PM - 2:30 PM EDT)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
4th Annual Data Integrity Validation August 15 - 16, 2018
Cambridge, MA)
Partnering with IDNs August 15 - 16, 2018
Philadelphia, PA)
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1pm-2:30pm EDT, Online Training
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Arlington, VA
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