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: rituximab
Pfizer Announces Launch Dates for Rituximab and Trastuzumab Biosimilars
At an earnings call this week, Pfizer’s CEO highlighted the impending launches of Ruxience® and Trazimera®, not long after the previously announced launch of Zirabev® (bevacizumab) at the end of this year. The New York–based pharmaceutical manufacturer plans to begin marketing Ruxience in January 2020, and Trazimera February 15, 2020. This would make Pfizer first … Continue reading Pfizer Announces Launch Dates for Rituximab and Trastuzumab Biosimilars
Do Skinny Labels for Biosimilars Matter to Payers?
Extrapolation of indications by the Food and Drug Administration (FDA) has been widely accepted by providers, payers, and most patient groups. Yet how to address the approval of a narrow indication list (or skinny label) seems less settled. The four FDA-approved adalimumab biosimilars received the agency’s endorsement for a large set of Humira®’s 10 indications. … Continue reading Do Skinny Labels for Biosimilars Matter to Payers?
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
Apotex/Apobiologix: Success in Canada, but Are They Shelving Biosimilars in the US?
Apotex has recently made news in Canada, introducing biosimilars and obtaining marketshare there. However, the story of Apotex and its Apobiologix biosimilar subsidiary in the US is less positive. As we’ve listed in our updated table, Apotex had originally filed for approval for its pegfilgrastim biosimilar with the FDA in late 2014 and its filgrastim … Continue reading Apotex/Apobiologix: Success in Canada, but Are They Shelving Biosimilars in the US?
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
Sandoz Decides Against Marketing Rituximab Biosimilar in US
On October 30, Novartis announced that it was culling its investigational drug pipeline and dropping 20% of its development programs. Just three days later, its subsidiary Sandoz announced that it would halt its efforts to obtain approval for its biosimilar version of rituximab from the US Food and Drug Administration (FDA). The decision by Sandoz … Continue reading Sandoz Decides Against Marketing Rituximab Biosimilar in US
Fresenius Kabi and Celltrion Get Good News
A German manufacturer is considering its options after the successful completion of two clinical studies involving a pegfilgrastim biosimilar (MSB11455). Fresenius Kabi, which completed its purchase of the biosimilar business from Merck KGaA in September 2017, announced its investigational biosimilar agent had proved sufficiently similar to the reference product Neulasta® in these phase 1 investigations … Continue reading Fresenius Kabi and Celltrion Get Good News
Celltrion’s Rituximab Biosimilar Earns Positive Review
The information package released by reviewers for the Food and Drug Administration (FDA) indicates that a positive recommendation for Celltrion’s rituximab biosimilar is likely at the Advisory Committee meeting on October 10. The members of the Oncologic Drugs Advisory Committee will review the data and hear public comments before voting to recommend that the FDA … Continue reading Celltrion’s Rituximab Biosimilar Earns Positive Review
A Profile on Lesser-Known Player in the Biosimilar Space: Archigen Biotech
On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this post, we highlight a joint venture between AstraZeneca and Samsung … Continue reading A Profile on Lesser-Known Player in the Biosimilar Space: Archigen Biotech