Biosimilars
AE reporting for biologicals
Researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) sought to answer [1] examined primary suspect reports sent to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) from US reporters for two biologicals that have lost patent exclusivity – somatropin and human insulin. The study was carried out to inform both FDA and the global drug development community about how naming of biosimilars might affect the traceability of adverse events (AEs).
Positive phase III results for etanercept biosimilar
On 9 November 2015, biopharmaceutical specialists Coherus and Baxalta (a spin-off company from Baxter International) announced positive results from a phase III study of its etanercept biosimilar (CHS-0214).
Biosimilar naming in the US, the debate continues
The United States Pharmacopeial Convention (USP) has called on the US Food and Drug Administration (FDA) to reconsider its draft guidance Nonproprietary Naming of Biological Products: Guidance for Industry.
Biosimilar naming conventions around the world
Naming conventions from around the world was one of the topics investigated in a study by researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) [1].
Positive phase III results for Samsung Bioepis biosimilars
Results of phase III clinical studies of candidate etanercept biosimilar SB4 infliximab biosimilar SB2 and adalimumab biosimilar SB5 have all met their primary endpoints, according to an announcement on 7 November 2015 by Samsung Bioepis (a Biogen and Samsung joint venture).
Celltrion submits rituximab biosimilar application to EMA
South Korean biotechnology company Celltrion has, according to Business Korea, submitted a second biosimilar application to the European Medicines Agency (EMA).
Biologicals patent expiries
Biosimilars are now a reality. The European Medicines Agency (EMA) approved its first biosimilar back in 2006 [1] and, with the increasing price of new biologicals and continuing pressure on healthcare budgets, biosimilars are expected to make up an increasing share of the biologicals market.
Biosimilars and interchangeability
In a study by researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) the question of interchangeability around the world was one of the topics investigated [1].
Economic considerations for rheumatoid arthritis biosimilars
In the paper by Gulácsi et al. [1], the authors stated that biosimilars have the potential to reduce costs and increase patient access to biologicals in the treatment of rheumatoid arthritis (RA) and other chronic inflammatory rheumatic and bowel diseases.
Formycon starts phase III trial for ranibizumab biosimilar
German biosimilars companies Formycon and Bioeq announced on 7 October 2015 that they had initiated a pivotal phase III clinical trial with their candidate ranibizumab biosimilar (FYB201).
