Gedeon Richter says that if its European denosumab filing continues along its current trajectory, “there’s a high probability that we can launch on time and have a relatively short approval process, which gives hope that the denosumab launch taking place next year will be successful.”
Richter Eyeing 20%+ Margin On Denosumab As Part Of 2027 Profit Plans
Peak Sales For Prolia/Xgeva Biosimilar Tipped At €80m; US Filing ‘Not Yet Happened’
Gedeon Richter is feeling good about its plan to launch a biosimilar denosumab product in the EU in 2025, as it continued to slow down losses for its biopharma unit ahead of plans to swing to profitability later in the decade.
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With sales and profits shooting up in 2024, Alvotech has revealed plans to rapidly accelerate development to add between four and six programs to its pipeline of biosimilars every year, while at the same time unveiling details of several new brands that it will be seeking to challenge. The firm has also set out longer-term financial targets that anticipate more than trebling its revenues in the next three years.
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After announcing updates in its ongoing legal battle and a leadership shakeup earlier this fiscal year, Hyloris closed 2024 with a slight rise in revenue and a shrinking of its reported net loss.
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Months on from penning a landmark commercial and manufacturing agreement for GLP-1 assets with Metsera, Amneal says it is happy with how the partnership is shaping up.
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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
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Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
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Generics Bulletin previews the most noteworthy and anticipated events for April 2025.