The EU’s CHMP has given the green light to Imraldi, Samsung Bioepis’ biosimilar version of AbbVie’s blockbuster adalimumab product Humira. If approved by the European Commission, this will be the South Korean company’s third biosimilar anti-TNF alpha product to gain a marketing authorization in the EU.
The European Medicines Agency’s scientific committee, the CHMP, has recommended approval of Samsung Bioepis Co. Ltd.’s Imraldi (SB5), a biosimilar version of AbbVie Inc.’s blockbuster TNF-alpha inhibitor, Humira (adalimumab).
The product was OKd for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa,
As CEO Anderson backs high prices for innovative drugs in Europe
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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The novel RAF/MEK inhibitor and FAK inhibitor are the first treatment approved specifically for KRAS-mutated recurrent low-grade serious ovarian cancer (LGSOC).
The drugmaker won US FDA approval for the HIF-2α inhibitor in pheochromocytoma and paraganglioma, a rare cancer of the adrenal glands, in adolescents and adults.
Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.
Shares are hit as German conglomerate lowers revenue forecast.
