Truxima becomes the 15th biosimilar, and the first version of Rituxan (rituximab), to be approved in the US. A settlement agreement with Roche will allow Teva to market the product but the launch date has not been revealed.
The US Food and Drug Administration (FDA) gave the thumbs up to Truxima this week, making it the first biosimilar version of Roche/Genentech’s Rituxan to be approved in the US.
The product is manufactured by South Korean firm Celltrion but will be marketed in the US by Israeli drugmaker Teva Pharmaceutical Industries, after the two companies entered into a $160 million (€140 million) partnership in 2016.
Truxima becomes the 15th biosimilar to be approved in the US. Image: iStock/zimindmitry
While approval has been won, the questions of launch date and pricing remain unanswered. However, both Teva and Celltrion told BioProcess Insider legal issues with reference drugmaker Genetech have been resolved.
“Teva and Celltrion have reached a settlement agreement with Genentech that allows Teva to market Truxima,†said Teva spokesperson Yonatan Beker. “However, the terms and conditions of that agreement – including launch timing – are confidential at this time.â€
Manufacturing
The approval came on the second attempt for Celltrion after the firm received a complete response letter (CRL) for Truxima – previously known as CT-P10 – in April this year.
The letter cited an FDA warning letter​ highlighting “multiple poor aseptic practices†at Celltrion’s production site in Songdo, Incheon where the product is made.
Fellow biosimilar maker Sandoz, which has a rituximab biosimilar approved in Europe, also received a CRL in June this year for its biosimilar candidate asking for additional data to complement the submission. The firm has since pulled its US rituximab program.
A second letter was sent for Celltrion’s proposed biosimilar to Roche’s Herceptin (trastuzumab), CT-P6. If approved, the biosimilar will also be marketed in the US by Teva.
US biosimilars
Truxima is the 15th biosimilar to be approved in the US. FDA commissioner Scott Gottleib said: “The Truxima approval is our third biosimiliar approval in the past month. The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share as this industry matures.â€
The full list is as follows:
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March 2015: Sandoz’s Zarxio (filgrastim-sndz), a version of Amgen’s Neupogen
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April 2016: Pfizer’s Inflectra (infliximab-dyyb ), a version of J&J’s Remicade
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August 2016: Sandoz’s Erelzi (etanercept-szzs), a version of Amgen’s Enbrel
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September 2016: Amgen’s Amjevita (adalimumab-atto), a version of AbbVie’s Humira
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April 2017: Samsung Bioepis/Merck’s Renflexis (infliximab-abda), a version of J&J’s Remicade
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August 2017: Boehringer-Ingelheim’s Cyltezo (adalimumab-adbm), a version of AbbVie’s Humira
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September 2017: Amgen and Allergan’s Mvasi (bevacizumab-awwb), a version of Roche’s Avastin
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December 2017: Mylan and Biocon’s Ogivri (trastuzumab-dkst), a version of Roche’s Herceptin
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December 2017: Pfizer’s Ixifi (infliximab-qbtx), a version of J&J’s Remicade
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May 2018: Pfizer’s Retacrit (epoetin alfa-epbx), a version of Amgen’s Epogen and Procrit
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June 2018: Mylan and Biocon’s Fulphila (pegfilgrastim-jmdb), a version of Amgen’s Neulasta
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July 2018: Pfizer’s Nivestym (filgrastim-aafi), a biosimilar to Amgen’s Neupogen
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Oct 2018: Sandoz’s Hyrimoz (adalimumab-adaz), a biosimilar to AbbVie’s Humira
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Nov 2018: Coherus’s Udenyca (pegfilgrastim-cbqv), a version of Amgen’s Neulasta
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Nov 2018: Celltrion’s Truxima (rituximab-abbs), a version of Roche’s Rituxan