Biosimilars
Non-originator low molecular weight heparins: generics or biosimilars
First developed in the 1980s, low molecular weight heparins (LMWHs) are complex anticoagulants derived from porcine intestinal mucosa and are used in the treatment of deep vein thrombosis and pulmonary embolism. Heparin sodium’s anticoagulant activity is mainly governed by its ability to bind to the serine protease inhibitor antithrombin (AT). In this sense, heparin sodium functions as a cofactor for AT by modifying its conformation, thereby accelerating the inactivation of clotting factors.
Positive phase I results for adalimumab biosimilar
In an announcement on 28 October 2015, biopharmaceutical specialist Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) claimed that results from a phase I study of its adalimumab biosimilar (BI 695501) had ‘demonstrated pharmacokinetic bioequivalence’ to Humira (adalimumab).
Biosimilar naming and AE reporting
How will biosimilar naming affect the ability to attribute adverse events (AEs) to a particular product? This is a question researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) sought to answer [1].
Biosimilars of ranibizumab
Last update: 4 December 2020
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1].
Boehringer Ingelheim stops biosimilar rituximab development
Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) has reportedly halted clinical development for its biosimilar version (BI 695500) of Roche’s blockbuster leukaemia treatment Rituxan/MabThera (rituximab).
Rituximab biosimilar claimed similar pharmacokinetics to originator
A phase I/II study of Pfizer’s rituximab biosimilar candidate PF-05280586 has shown similar pharmacokinetic (PK) properties, according to Jacobs and co-authors [1].
Biosimilars use in Italy increasing
A study of the use of biosimilars in four large Italian geographic areas has found that the use of biosimilar erythropoiesis-stimulating agents (ESAs), especially in naïve patients, increased significantly during the years 2009–2013 [1].
Call for compulsory license for biosimilar trastuzumab emtansine
A pressure group, which includes both patients and doctors, has called for the UK Government to overturn patents on Roche’s breast cancer treatment Kadcyla (trastuzumab emtansine).
Candidate infliximab biosimilar SB2 equivalent to Remicade
Results from a phase III clinical trial for a candidate biosimilar version of infliximab in patients suffering from rheumatoid arthritis has shown SB2 to be equivalent to Remicade [1].
Insulin glargine biosimilar in US delayed until end 2016
Pharmaceutical majors Eli Lilly and Sanofi announced on 28 September 2015 that the two companies had agreed to end the legal dispute over biosimilar insulin glargine in the US and to discontinue similar disputes worldwide.
