November 25th 2023
By Deana Ferreri, PhD
A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.
July 10th 2023
By Justina Petrullo
Noninferiority and comparable safety and immunogenicity between biosimilar romiplostim (ENZ110) and innovator romiplostim (Nplate) were identified in patients with chronic immune thrombocytopenia.
May 31st 2023
By Skylar Jeremias
The European Commission has granted marketing authorization to Samsung Bioepis' biosimilar referencing Soliris (eculizumab). The product, dubbed Epysqli, is the first hematology biosimilar from Samsung Bioepis to be approved in the European Union.
April 12th 2023
The Committee for Medicinal Products for Human Use gave a thumbs up for an eculizumab biosimilar, and a biologic license application for a bevacizumab biosimilar was accepted in Brazil.
March 4th 2023
Authors of a review of safety results across indications and study designs on the epoetin alfa biosimilar HX575 concluded that HX575 “has repeatedly demonstrated long-term safety” in all approved indications in both clinical trials and real-world studies.
September 10th 2022
A phase 1 study of an enoxaparin sodium biosimilar Cloti-Xa established similar pharmacodynamics and pharmacokinetic profiles with the reference product (Clexane, Lovenox) in healthy participants.
August 24th 2022
By Mary Caffrey
Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare bone marrow disorder in which expansion of certain hematopoietic cells that lack a key protein cause the destruction of red blood cells, or hemolysis.
August 13th 2022
A phase 1 study compared pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity between SB12, a proposed eculizumab biosimilar, and EU and US reference products (Soliris) in healthy adults.
July 14th 2022
Abstracts from the European Hematology Association Congress 2022 confirmed comparable safety and effectiveness profiles between 2 rituximab biosimilars and the reference product (Rituxan) in patients with large B-cell lymphoma.
June 21st 2022
Abstracts from the 2022 European Hematology Association (EHA) Congress presented positive data for 2 biosimilar candidates referencing Soliris (eculizumab).
