Biosimilar Regulatory solution center

  1. What Brazil Can Learn From Denmark’s Biosimilar Policies

    In this article I continue to outline some of the Brazil Ministry of Health's biggest questions about post-market surveillance, big data, and procurement, as these are particularly telling of how the nation’s biosimilar policy could take shape in the future.

  2. How The Regulatory Pathway Shapes Biosimilar Business Decisions

    I took the opportunity to pick editorial board member Hubert Chen's brain about the ins and outs of the 505(b)(2) pathway, which led to an even larger discussion about the critical impact a regulatory pathway can have on a company's business decisions and strategies.

  3. Brazil’s Ministry Of Health Weighs Biosimilar Safety, Interchangeability

    Though the extent to which biosimilars will be used in Brazil is still unclear, I’m hopeful that several discussions on safety, efficacy, and interchangeability will provide a successful path forward for the country.

  4. What Can Biosimilar Developers Learn From The 1990s Biopharma Industry?

    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.

  5. Biosimilars In Brazil: Healthcare Salvation Or Waterloo?

    I was recently given a first-hand look at some of the unique market-related challenges standing in the way of Brazil taking full advantage of biosimilars. In the first of this two-part article, I will provide a closer look at some of these challenges and what these may mean for the Brazilian biosimilar industry moving forward.  

  6. 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.     

  7. 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.

  8. 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.

  9. 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.


  10. 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.