When Pfizer announced its intention just more than a week ago to begin marketing its rituximab biosimilar Ruxience® in January 2020, industry watchers wondered when we might hear a response from its sole approved competitor. The wait was over quickly: Teva and Celltrion will begin shipping their own rituximab biosimilar Truxima® on November 11. Truxima … Continue reading Partners Teva/Celltrion Seek the Jump on Pfizer, Launch Their Rituximab Biosimilar Next Week
Tag: Truxima
The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab
In a busy beginning of the week, the US Food and Drug Administration approved new biosimilars for Humira®and Rituxan®. Samsung Bioepis gained approval for Hadlima™ (adalimumab-bwwd), and Pfizer scored with Ruxience™ (rituximab-pvvr). HADLIMA The approval for Hadlima covers the following indications: Rheumatoid arthritisJuvenile idiopathic arthritisPsoriatic arthritisAnkylosing spondylitisCrohn’s disease in adultsUlcerative colitisPlaque psoriasis Formerly known as SB5, … Continue reading The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab
Rituximab Biosimilar Approved by FDA for Cancer Treatment
On November 28, 2018, the Food and Drug Administration (FDA) announced the approval of rituximab-abbs (Truxima™), produced by Celltrion and marketed by Teva. Approval for this rituximab biosimilar was overwhelmingly recommended by the FDA’s Oncology Drug Advisory Committee by a vote of 16-0 in October. It is the first biosimilar agent approved for the treatment … Continue reading Rituximab Biosimilar Approved by FDA for Cancer Treatment
FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar
Sandoz announced today that the Food and Drug Administration (FDA) has decided not to approve its biosimilar version of the oncology biosimilar rituximab. The content of the complete response letter was not revealed by Sandoz. This marks the second rituximab biosimilar rejected by the FDA. Celltrion and Teva’s Truxima™ was also rejected in early April. … Continue reading FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar
Rituximab and Filgrastim Biosimilars Being Reviewed by FDA
Sandoz's Rituximab and Adello Biologic' Filgrastim Biosimilars Submitted to FDA
Celltrion’s Rituximab Recommended for Approval in Europe
Just weeks after Celltrion presented data at the American College of Rheumatology meeting demonstrating that its product CT-P10 is as safe and effective as Rituxan® for the treatment of rheumatoid arthritis (RA), the European Medicines Agency (EMA) received the recommendation to approve the product for use in the EU.