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The lack of biosimilars in the growth hormone deficiency (GHD) treatment pipeline does not signify a missed opportunity, because superior products exist in the form of next-generation biologics known as biobetters, says an analyst with research and consulting firm GlobalData.
According to Dr Lakshmi Dharmarajan, GlobalData's analyst covering Cardiovascular & Metabolic Disorders, all the drugs currently in late-stage development for GHD in the seven major markets, namely the US, France, Germany, Italy, Spain, UK, and Japan, are long-acting growth hormone (GH) drugs, or GH biobetters.
Dr Dharmarajan explained, "Despite the patent expirations of the originator drugs, there are no biosimilars in the GHD treatment pipeline. Instead, long-acting GH biobetters will have an increased chance of market uptake upon entry, as they address the unmet need for improved compliance while offering a clinical advantage over their predecessors.
"Additionally, biobetters can be approved through the established regulatory pathways, whereas the biosimilar guidelines are still somewhat murky. While GH biobetters require more time and investment for development, the net payoff is higher when they are marketed due to their premium pricing."
On the other hand, high biobetter prices could facilitate the adoption of GH biosimilars, because these products are expected to significantly reduce treatment costs.