Biosimilars

Inflectra shows comparable results in IBD patients

Biosimilars/Research | Posted 12/06/2015

US-based generics maker Hospira presented preliminary results from its Hungarian National Registry study for its infliximab biosimilar Inflectra at the European Crohn’s and Colitis Organisation Inflammatory Bowel Diseases (ECCO-ibd) conference, which was held in Barcelona, Spain on 18–21 February 2015.

Spanish Society of Rheumatology issues position statement on biosimilars

Biosimilars/General | Posted 12/06/2015

The Spanish Society of Rheumatology (Sociedad Española de Reumatología, SER) has issued a position statement on biosimilars, reflecting its views on issues such as interchangeability and traceability of biosimilars.

Cost of filgrastim biosimilars compared to originator filgrastim

Biosimilars/Research | Posted 05/06/2015

Italian researchers have completed a retrospective cost analysis comparing the use of filgrastim biosimilars with the originator granulocyte colony-stimulating factor (G-CSF). Their retrospective, single institution study of 56 lymphoma and myeloma patients concluded that treatment with the biosimilars Tevagrastim and Zarzio was associated with cost reductions of 56% and 86%, respectively.

Biosimilars applications under review by EMA – April 2015

Biosimilars/General | Posted 05/06/2015

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Indian drugmakers make progress with candidate biosimilars

Biosimilars/News | Posted 05/06/2015

India-based biologicals specialist Biocon announced on 7 May 2015 that it had made clinical progress in its partnered programmes with US generics maker Mylan.

Clinical trials for infliximab biosimilars

Biosimilars/Research | Posted 29/05/2015

A systematic review into clinical trials for infliximab biosimilars was carried out as part of an investigation into biosimilars for the treatment of psoriasis by researchers from the Charité – Universitätsmedizin Berlin, Germany [1].

Incomplete processing in recombinant streptokinase

Biosimilars/Research | Posted 29/05/2015

A study investigating the impact of incomplete processing on streptokinase activity has found that ‘similar biologics’ or different batches of the biological may have different potencies, depending on the degree of amino-terminal methionine processing and on the pharmacopoeial assay method used, affecting the dosage patients receive [1].

Latin American deal for infliximab biosimilar

Biosimilars/News | Posted 29/05/2015

US-based Epirus Biopharmaceuticals (Epirus) announced on 14 May 2015 that it had made a deal with biosimilars specialist mAbxience, a subsidiary of Spanish healthcare firm the Chemo Group, for Latin America with respect to the infliximab biosimilar made by Epirus.

GPhA launches Biosimilars Council

Biosimilars/General | Posted 29/05/2015

As part of ongoing efforts to educate and expand access to biosimilars, industry group, the US Generic Pharmaceutical Association (GPhA), has launched its Biosimilars Council, a division of GPhA.

Baxter and Coherus amend biosimilar etanercept collaboration

Biosimilars/News | Posted 29/05/2015

US-based biosimilars developer Coherus BioSciences (Coherus) and Baxter International (Baxter) announced on 15 April 2015 that they had amended some of the financial terms of their collaboration agreement for CHS-0214, an etanercept biosimilar candidate.