Biosimilars

Biosimilar naming and AE reporting

Biosimilars/Research | Posted 30/10/2015

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

Biosimilars/General | Posted 30/10/2015

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

Biosimilars/News | Posted 30/10/2015

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

Biosimilars/Research | Posted 30/10/2015

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

Biosimilars/Research | Posted 23/10/2015

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

Biosimilars/General | Posted 23/10/2015

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

Biosimilars/Research | Posted 23/10/2015

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

Biosimilars/News | Posted 23/10/2015

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.

Australia’s DoH seeks feedback on biosimilars awareness project

Biosimilars/General | Posted 16/10/2015

Australia’s Department of Health (DoH) wants to improve awareness and confidence in biosimilars in the community and among healthcare professionals, including pharmacists and prescribers. To do this the DoH has developed an implementation framework, for which it is seeking feedback.

Pharmacovigilance compliance for biocomparables in Mexico

Biosimilars/Research | Posted 16/10/2015

Filgrastim is widely used in Mexico, as in other countries. Its patent has expired and hence several non-originator biologicals have appeared. Following WHO guidelines, the General Health Law of Mexico was modified in 2009 to provide a solid regulatory environment for biosimilars (or biocomparables as they are called in Mexico) [1].