Kabi Brings In Reddy’s Rituximab As Biosimilar Breakeven Date Retreats

Indian Firm’s Rituxan Biosimilar Added Amid Pegfilgrastim Frustrations

The Fresenius group had much to say of Fresenius Kabi’s biosimilar business during the firm’s Q4 and year-end results call, which disclosed a US in-licensing deal for Dr Reddy’s proposed rituximab biosimilar and suggested additional biosimilar manufacturing is among its top priorities.

high jump
Kabi is hoping soon to get over its pegfilgrastim hurdle • Source: Alamy

Fresenius Kabi has in-licensed exclusive US commercialization rights to Dr Reddy’s Laboratories proposed biosimilar Rituxan/MabThera (rituximab) product, as the German firm once again pushed back its expectations for its biosimilars business to break even at the EBITDA level.

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Organon Looks To Tap Tocilizumab Potential Following Biogen Acquisition

 
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Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.

Who’s Hired? Alvotech Appoints Strategy And Quality Chiefs

 
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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.

Richter Confirms European Tocilizumab Filing

Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.

Accord’s Denosumab Biosimilars Get Thumbs-Up From EMA

 
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Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.

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Teva Provigil ‘Pay For Delay’ Fines Should Stand, AG Says

 
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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.

Who’s Hired? Alvotech Appoints Strategy And Quality Chiefs

 
• By 

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.

Richter Confirms European Tocilizumab Filing

Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.