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?
In addition to laying out some of the concerning themes that came up throughout the hearing, I will unpack some of the FDA’s lines of inquiry which I feel illuminated the agency’s efforts to challenge certain claims for the first time.
Though there’s much to write about the successes and pitfalls in the European, U.S., and Canadian biosimilar markets, it turns out there’s quite a bit that biosimilar makers need to learn about the countries off the beaten market-access path. And in many of these nations, the capacity for a biologics market already exists.
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.
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.
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.
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.
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.
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.
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.
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