Celltrion Hit By Truxima Price Cut, Temporary Utilization Rate Drop
Intensifying competition in the global biosimilars space and a temporary drop in its factory utilization rate took a toll on Celltrion's earnings in the third quarter, but analysts still expect a rosy outlook next year amid the expected US launches of biosimilar rituximab and trastuzumab, and the first subcutaneous version of Remsima on the horizon in Europe.
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Thwarted by the FDA, Novartis sees better opportunities for other biosimilars in its portfolio and has decided not to pursue a refiling for its version of Roche's blockbuster Rituxan. However CEO Vas Narasimhan told Scrip that the US remains very much a focus of the group's biosimilars strategy.
Oncologic Drugs Advisory Committee says totality of evidence supports licensure of CT-P10 for three lymphoma indications, but panelists question what additional data would be needed to eventually get Rituxan’s other approved uses, which were carved out for patent and exclusivity reasons, onto the biosimilar’s label.
Helped by new guidelines, South Korean pharma and biotech firms now have clearer standards related to the reflection of R&D costs in their accounting books, with some pointing out that biosimilar companies may be the biggest beneficiaries.