Roche predicts its existing Lucentis (ranibizumab) franchise will be “cannibalized” by biosimilars in the US, with the first rival product sets to launch in June 2022 and beyond.
Roche Feels Lucentis Market Could Move On Before Biosimilars Debut
Two New Ophthalmology Products Will Challenge Biosimilars, Roche Believes
Roche upended expectations for biosimilar Lucentis (ranibizumab) in the US, with a recent licensing deal signed with biosimilar sponsor Samsung Bioepis keeping the first proposed rival from the market until June 2022. The originator is also confident its pipeline assets will stem competition.
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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.
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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.
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.
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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 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.
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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?
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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.