The Doctrine Of Equivalents — A Major Barrier For The Marketability Of Biosimilars
The Doctrine Of Equivalents — A Major Barrier For The Marketability Of Biosimilars

Often there is a great deal of confusion regarding why manufacturers wait so long to market their biosimilars despite having a more abbreviated pathway than innovator biologics. Other times, manufacturers and investors will be caught off-guard when a court blocks marketing of their biosimilars despite them having obtained FDA approval. Mitigating preventable uncertainty warrants understanding some of the underlying mechanisms related to the “patent dance.” This is the first of two articles that will address the patent infringement issues often used against biosimilars by sponsor biologic owners to delay or derail marketing of the biosimilar.     

  • The Great Canadian Biosimilar Transition: One Payer’s Strategy
    The Great Canadian Biosimilar Transition: One Payer’s Strategy

    Green Shield Canada, a private payer, has created a biosimilar policy and is currently rolling out a pilot biosimilar transition program among its clients. Though it’s still in the early stages, this is an intriguing program to keep our eyes on as the market advances in Canada.

  • 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.

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4th Annual 340B Manufacturer Summit August 21 - 22, 2018
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Bio/Pharma Forum on the State of Medicare Reform August 21, 2018
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Understanding & Implementing The Revised NIH & FDA Clinical Trial Protocol Template August 21 - 21, 2018
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Key Elements of Pharmaceutical Serialization and Track & Trace Systems: Implementation and Compliance Best Practices September 12 - 12, 2018
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 EVENTS

4th Annual 340B Manufacturer Summit August 21 - 22, 2018
Arlington, VA)
Bio/Pharma Forum on the State of Medicare Reform August 21, 2018
Arlington, VA)
Understanding & Implementing The Revised NIH & FDA Clinical Trial Protocol Template August 21 - 21, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Measuring Medical Affairs Success – Identifying the Key Performance Indicators (KPIs) for Successful Teams August 24 - 24, 2018
1:00 PM - 2:00 PM EDT)
Duration:  60-Minutes
Price:  $199 - Includes Bonus Handouts!
Laboratory Data Integrity: Current Expectations for OOS Result Investigations August 29 - 29, 2018
1:00 PM - 2:30 PM EDT)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!

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