Guest Columns

91. The Benefits Of Real-World Evidence (RWE) For Biosimilars And Special Populations 9/4/2018

    While RWE can serve as a key complement to clinical studies in the development of a wide range of therapies, there are specific instances for which RWE is particularly beneficial and indeed the only available evidence to support regulatory approval. RWE has the potential to spur the uptake of biosimilars in the U.S. market and to provide information on a drug’s efficacy and safety in special populations that may otherwise be excluded from clinical trial studies.

92. What Can Biosimilar Developers Learn From The 1990s Biopharma Industry? 8/22/2018

    This article highlights some of the early biologics industry decisions and thought processes and the subsequent actions and opportunities biosimilars create for the pharma industry.

93. The Doctrine Of Equivalents — A Major Barrier For The Marketability Of Biosimilars 8/16/2018

    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.     

94. A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief 8/9/2018

    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.

95. What Pharmacists Need From Biosimilar Developers 7/31/2018

    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.

96. Innovators' Next-Gen Strategy: Is Obsolescence The Best Biosimilar Defense? 7/26/2018

    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.

97. Patentable Subject Matter Barriers For Biosimilars — And How To Overcome Them 7/17/2018

    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.

98. How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often 7/13/2018

    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. 

99. Working With Patient Groups To Strengthen Biosimilar Understanding 7/3/2018

    When it comes to biosimilars, building confidence that these medicines can deliver the same experience as a branded medicine will require more than communicating successful trial results.

100. Can Real-World Evidence Improve Market Access For Biosimilars In The U.S.? 6/29/2018

     A look at the role real-world evidence (RWE) can play in increasing the uptake of biosimilars in the U.S. market and some of the challenges in leveraging the potential of RWE.