1. 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.     

  2. 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.

  3. One Way Biosimilar Manufacturers Could Improve Payer Relationships

    Outside the world of rebate traps, product bundling, and seemingly water-tight innovator contracting efforts, there is certainly still room for biosimilar manufacturers to improve their own payer strategies. Ned Pojskic, an expert from Green Shield Canada, shares one simple solution.

  4. What Pharmacists Need From Biosimilar Developers

    Pharmacists can play an important role in the biosimilar ecosystem, educating prescribers about the benefits of biosimilars and serving as final gatekeepers to their adoption. For a behind-the-lines perspective on pharmacists’ current views regarding biosimilars — and what developers should be doing to engage them as allies in driving biosimilar uptake — we reached out to Steven Lucio of Vizient Inc., a group purchasing organization (GPO) with over $50 billion in total member spend. As associate VP of Pharmacy Services, Lucio provides education to Vizient’s member organizations on topics such as benchmarking pharmacy costs for critical drug classes, evaluating the expense of high-cost biologics, and preparing for implementation of biosimilar medications.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


  9. 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.

  10. 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.