Although there appears to be a gap in the market for biosimilars in growth hormone deficiency indications, this does not show a missed opportunity since superior products exist in the form of next-generation biobetters, says an analyst from research and consultancy firm GlobalData.
All of the drugs in late-stage development for growth hormone deficiency in the seven major markets are long-acting growth hormone drugs, or biobetters, according to Lakshmi Dharmarajan.
Dr Dharmarajan says: “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.”
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