Unlike many other biosimilar products, there is little experience with insulin. Globally, only one version has been approved: Eli Lilly’s version of insuline glargine (e.g., Abasaglar® in Europe and Basaglar® in Australia, in 2015 and 2014, respectively). Yet, the size of the market is many times the size of markets for drugs like anti-TNFs or filgrastim, for which several biosimilars have been approved and many years of data have been accumulated.
Like the case of somatropin and Teva’s version of filgrastim in the US, Eli Lilly and Boehringer Ingelheim elected to go the 351(a) biologic license application route to the FDA for a “follow-on biologic” for its version of insulin glargine (Basaglar® for the US market). Regardless, the drug is the same as the biosimilar produced for the global market. The FDA approved the drug in December 2015.
Unlike many other biosimilars, insulin is not too difficult and more importantly, far less expensive to produce (which may make insulin attractive to prospective manufacturers). This is a fertile area of development; half a dozen companies have applied or are close to applying for various forms of insulin. This raises questions about biosimilar pricing.
Another interesting question with biosimilar insulins is the compatibility of one cartridge or pen with another brand or innovator product. If each new product has its own pen delivery system, then additional resources will need to be spent on education for both providers and their patients.
A major consideration with biosimilar insulin is its placement on the drug formulary. Insulin is rarely on a specialty tier. Value-based benefit designs seek to maximize access to proven agents like this, meaning waived or tier 1 copays. If a payer opts for a biosimilar insulin, would the innovator version be placed on a specialty tier or even excluded?
In a number of ways, insulin does seem to break the mold of what we expect from a biosimilar product and how it may be managed. It will require additional thinking to figure out how it fits in with treatment of type 1 and type 2 diabetes. It will be very interesting to see how the market for it develops in the US and beyond.
For more detail on several of these concepts, please read my blog at the Center for Biosimilars