How Can We Make FDA’s Biosimilar Action Plan A Game-Changer?
How Can We Make FDA’s Biosimilar Action Plan A Game-Changer?

Despite all the FDA’s efforts to increase review time and get products to market more quickly, I remain unconvinced that the BAP will turn around the U.S. market — at least not our current market. So what can we do in the meantime?

  • How Mylan Used Partnering Deals To Become A Key Player In Biosimilars
    How Mylan Used Partnering Deals To Become A Key Player In Biosimilars

    Mylan’s roots are firmly based in the small-molecule generics business; however, the company has positioned itself as a strong competitor in the biosimilar field with the help of key strategic partnerships in recent years. This article explains how the company expanded its access to different biosimilars and given it more rapid access to key biosimilar markets.

  • Should U.S. Drug Makers Enter Europe Via The Netherlands (Not The UK) Post-Brexit?
    Should U.S. Drug Makers Enter Europe Via The Netherlands (Not The UK) Post-Brexit?

    By March 30, 2019, the European Medicines Agency (EMA) will officially relocate its headquarters from London to Amsterdam — just one of many implications of the UK’s departure from the EU. As a result, U.S. pharmaceutical companies could begin turning to the Netherlands instead of the UK when launching new medicines in Europe post Brexit.

  • The Benefits Of Real-World Evidence (RWE) For Biosimilars And Special Populations
    The Benefits Of Real-World Evidence (RWE) For Biosimilars And Special Populations

    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.

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

  • How The Regulatory Pathway Shapes Biosimilar Business Decisions
    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.

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

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

  • Biosimilars In Brazil: Healthcare Salvation Or Waterloo?
    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.  

  • 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.     

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