Samsung Bioepis Scoops First EU Lucentis Biosimilar As 2022 Date Looms

Byooviz Biosimilar Backed By EMA Committee In June

Samsung Bioepis has seen a positive opinion in the EU for its Byooviz (ranibizumab) biosimilar treatment for wet age-related macular degeneration turned into final approval by the European Commission. The company is also leading the pack in the US.

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Byooviz is to be marketed in Europe by Biogen • Source: Shutterstock

Samsung Bioepis Co., Ltd. is poised to be among the first wave of biosimilars to Lucentis (ranibizumab) in Europe, after the European Commission granted final approval for the Korean firm’s marketing authorization application.

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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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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.

Another One Bites The Dust: FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?

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.