CHMP OKs First EU Biosimilar Herceptin, And Another Version Of Humira
Samsung Bioepis’s Ontruzant is set to be the first biosimilar version of Roche’s Herceptin on the EU market after getting the all-clear from the EMA’s CHMP on Sept. 15. The committee has also OKd another version of AbbVie’s Humira, this time from Boehringer Ingelheim.
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Five of the nine products that could this week be recommended for EU approval have orphan designation. The final meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London.
The EMA’s CHMP is this week hearing oral evidence on two products it turned down in July – for schizophrenia and metastatic breast cancer – as well as on other drugs for multiple myeloma and multiple sclerosis.
AbbVie boosted its revenue guidance, increasing its longer-term Humira forecast from $18bn in 2020 to $21bn, raising the bar for drugs that will make up for revenue lost when biosimilar competition arrives in five years.