FDA Approves Two More Biosimilars

Regulatory NewsRegulatory News
| 23 July 2019 | By Zachary Brennan 

The US Food and Drug Administration (FDA) on Tuesday approved the 22nd and 23rd biosimilars: Pfizer’s Ruxience (rituximab-pvvr), which is the second biosimilar to Roche’s Rituxan (rituximab), and Samsung Bioepis’s Hadlima (adalimumab-bwwd), which could end up being the ninth biosimilar to AbbVie’s Humira (adalimumab).

Ruxience is approved as a treatment of adult patients with CD20-positive B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy, and CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with chemotherapy. Ruxience is also the first biosimilar approved to treat Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangitis (MPA), according to FDA.

Celltrion and Teva’s Truxima (rituximab-abbs) was approved last November as the first biosimilar to Rituxan (rituximab). Truxima has yet to launch in the US, but in the EU, adoption of Truxima and Sandoz’s Rixathon has topped 60%, according to Bernstein. Sandoz has since said it will not pursue a US biosimilar for rituximab.

Hadlima, meanwhile, which is expected to launch 30 June 2023, joins a crowded field of adalimumab biosimilars all gearing up for 2023 launch dates.

Amgen’s Amjevita (adalimumab-atto) was first approved in September 2016 and will launch 31 January 2023. Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) was approved second and will launch 1 July 2023. Sandoz’s Hyrimoz (adalimumab-adaz) was approved third and will launch 30 September 2023.

Coherus BioSciences, Pfizer, Mylan, Momenta and Fresenius Kabi also have settlements with AbbVie in place to launch their Humira biosimilars in late 2023 once FDA approved.

Editor's note: Article updated 7/24/19 to reflect that Samsung is the sole marking authorization holder and owner of Hadlima and not Merck, which is commercializing the product in the US.


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