Biosimilars

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].

Positive phase I results for pegfilgrastim biosimilar

Biosimilars/Research | Posted 16/10/2015

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 1 October 2015 that results from a phase I study of its pegfilgrastim biosimilar (CHS‑1701) had met its primary endpoint.

Baxalta and Momenta start phase III trial for adalimumab biosimilar

Biosimilars/News | Posted 16/10/2015

Baxalta – a spinoff company from Baxter International – and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 5 October 2015 that they had started a phase III clinical trial for their adalimumab biosimilar (M923) in patients with chronic plaque psoriasis.

European paediatricians advocate biosimilar trials in children with IBD

Biosimilars/General | Posted 09/10/2015

Paediatricians from Europe are concerned about the extrapolation of the limited amount of available clinical data from adults with rheumatologic diseases to children with inflammatory bowel disease (IBD) [1].

Answers to questions about anti-TNF biosimilars

Biosimilars/Research | Posted 09/10/2015

While the potential pharmacoeconomic benefits of cost-effective biosimilars seem clear, several issues have been raised regarding, for example, the definition of biosimilarity and the validity of indication extrapolation, as well as the ‘switchability’ and relative immunogenicity of biosimilars and their reference drugs. In a review by Isaacs and co-authors, these questions with reference to CT-P13 (Remsima, Inflectra), a biosimilar of the anti-tumour necrosis factor (TNF) monoclonal antibody infliximab (Remicade) were discussed [1].