Hematology

Phase 1 Study Demonstrates Bioequivalence Between Enoxaparin Biosimilar vs Reference Product

September 10th 2022

By Skylar Jeremias

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.

Phase 3 Study of Amgen Biosimilar to Eculizumab Meets Primary End Points

August 24th 2022

By Mary Caffrey

Article

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.

Phase 1 Study Finds Similar PK Between Eculizumab Biosimilar, Soliris

August 13th 2022

By Deana Ferreri, PhD

Article

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.

Rituximab Biosimilars Prove Effective in Large B-Cell Lymphoma

July 14th 2022

By Skylar Jeremias

Article

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.

EHA Abstracts Preview Potential for Eculizumab Contenders

June 21st 2022

By Skylar Jeremias

Article

Abstracts from the 2022 European Hematology Association (EHA) Congress presented positive data for 2 biosimilar candidates referencing Soliris (eculizumab).

Blood Clot Prevention Biosimilars Achieve Reimbursement in British Columbia

March 24th 2022

By Skylar Jeremias

Podcast

Three biosimilars used for blood clot prevention secure public reimbursement status in British Columbia, one of several Canadian provinces that has a biosimilar switching program.

SB12 Eculizumab Biosimilar Candidate Demonstrates PK, PD Equivalence in Phase 1 Trial

December 18th 2021

By Tony Hagen

Article

In a pharmacokinetic (PK) and pharmacodynamic (PD) trial in healthy participants, Samsung Bioepis' SB12 eculizumab biosimilar candidate demonstrated equivalence to Soliris, the reference product.

Xbrane Seeks to Bring Keytruda and Darzalex Biosimilars to Market

December 15th 2021

By Tony Hagen

Article

Xbrane Biopharma of Stockholm, Sweden, said its next biosimilar candidates will target the demand for oncology and hematology therapeutics.

EHA25 Virtual Roundup

June 18th 2020

By Skylar Jeremias

Video

Here is a summary of our coverage from EHA25 Virtual, the annual meeting for the European Hematology Association (EHA).

Data on Complement Inhibitors and Proposed Biosimilars Feature at ASH

December 10th 2019

By Kelly Davio

Article

During this week’s 61st meeting of the American Society of Hematology (ASH), researchers reported on eculizumab, a prospective biosimilar, and the long-acting ravulizumab.