This week, the American Conference Institute held its annual Biosimilar Conference in New York City to discuss the latest developments regarding the BPCIA, among other things. Below is a summary of some key discussions that took place at the meeting.
While we have only seen the approval of two biosimilar drugs to date, panelists anticipate the U.S. biologics market will be robust by 2020. Currently, there are 7 aBLAs pending at the FDA. In addition, at least 60 biosimilar development programs are underway for 19 different products, including at least 33 biosimilar products in phase 3 clinical trials. Panelists noted that innovators are also actively engaging in the development of biosimilar products. For example, Amgen, the reference product sponsor of various biologic drugs including Enbrel®, Neupogen®, and Neulasta®, is currently developing 9 biosimilar products of its own. Moreover, by 2020, there are 10 biologic blockbuster drugs that will be coming off patent. As a result, the U.S. market for biosimilars could see annual revenues of $11 billion (or more) by 2020.
Panelists also discussed how courts are preparing to handle litigation under the BPCIA. The Federal Circuit has held the patent dance is optional and the notice of commercial marketing, at least in cases where the parties did not engage in the patent dance, can only come after FDA approval. District courts are also starting to analyze situations in which the parties only engaged in part of the dance and the resulting ramifications. Panelists debated the advantages and disadvantage of choosing to engage in the patent dance and/or inter partes review. Many questions remain unanswered. However, the details of how biosimilar litigation will proceed are starting to develop and should become more clear in the coming years.
Naming of biosimilar products remains a heated topic given recent FDA guidance offered which proposes a naming convention in which a four letter suffix would be attached to the nonproprietary name describing the reference product. The panelists discussed the benefits and disadvantages of unique names, including whether or not unique names would facilitate or frustrate pharmacovigilance efforts or promote bias with prescribers with regard to any side effects. At this time, the panelists only seem to agree on the fact that the four letter suffix proposal from the FDA fails to complete address the pharmacovigilance concerns of reference product sponsors and bias concerns of biosimilar manufacturers.
Panelists also summarized the hurdles associated with getting states to adopt legislation regarding biosimilar substitution. To date, less than half the states have enacted legislation regarding biosimilar substitution. Panelists expect substitution laws to increase rapidly in the coming years now that there is a biosimilar product on the market.
Other topics discussed included comparing and contrasting U.S. and global biosimilar experiences, developing strategies for marketing and promoting biosimilar products, and strategic implications of the transition from NDA approval to BLA licensure.
As the conference highlights, there are many unresolved legal, regulatory, and commercial questions surrounding the emerging U.S. biosimilars landscape.