• 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.     

  • 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.

  • 6 Ways Biosimilar Companies Should Engage State Governments

    This article provides insights and several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial. 

  • Why Biosimilar Companies Should Pay More Attention To U.S. State Governments

    A critical mechanism in the U.S. constitutional framework is often overlooked in a larger public affairs strategy — the right of a state to govern itself in most aspects. This article conveys the importance of shifting resources from the federal campaign efforts to a more local effort to ensure biosimilar success.


Nicolas Arkells

Nicolas Arkells, JD, MBA, is the CEO at Manticore Consulting Group, a global health economics and outcomes consulting firm. He has over 15 years of leadership experience focusing on ensuring organizational commitment to statistical analysis and implementation. His law and science juris doctorate concentration in intellectual property allowed him to focus his research on biotechnology, market access, policy, regulatory strategy, and patent law. He is certified in medical devices and pharmaceuticals by the Regulatory Affairs Professionals Society, Lean Six Sigma Black Belt trained in the healthcare industry, agile certified as a PSM and PSPO, and advanced certified in global human capital through Columbia University. He has been recognized for excellence in legal research, alternative dispute resolution, and leadership.