Biosimilars/Research

Positive switching data for infliximab and etanercept biosimilars

Biosimilars/Research | Posted 31/08/2018

Sandoz, the generics division of Novartis, announced on 15 June 2018 results of new phase III, long-term and switching data for its infliximab biosimilar Zessly (PF‑06438179) and its etanercept biosimilar Erelzi in rheumatoid arthritis patients.

Switching from Basalin to Lantus effective in Chinese diabetes patients

Biosimilars/Research | Posted 24/08/2018

Switching from copy biological (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus, according to authors from the Qingdao Endocrine and Diabetes Hospital, China [1].

Safety and immunogenicity of originator and biosimilar trastuzumab

Biosimilars/Research | Posted 24/08/2018

A study carried out by international researchers reported results from the HERiTAge trial of Mylan/Biocon’s biosimilar trastuzumab, Ogivri (trastuzumab‑dkst) [1].

Positive phase III results for Amgen’s infliximab biosimilar

Biosimilars/Research | Posted 20/07/2018

Biotech giant Amgen announced on 27 June 2018 positive data from a phase III study of their infliximab biosimilar (ABP 710) compared to Remicade (infliximab).

Biosimilars: implications for oncologists

Biosimilars/Research | Posted 13/07/2018

In 2015, the US Food and Drug Administration (FDA) approved its first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since then, FDA has approved four additional biosimilar tumour necrosis factor α inhibitors, and in May 2017, the Oncology Drug Advisory Committee voted in favour of approval of an epoetin alfa biosimilar. Three biosimilar monoclonal antibodies (mAbs) have been approved in the US. Although their indications are for chronic inflammatory diseases, according to authors Robert Rifkin and Susan Peck, oncologists should become familiar with these agents, because they may need to administer these drugs for patients who have concurrent chronic inflammatory conditions [1].

Positive results for infliximab and trastuzumab biosimilars

Biosimilars/Research | Posted 13/07/2018

Celltrion Healthcare (Celltrion) and Samsung Bioepis have both announced positive results for their infliximab and trastuzumab biosimilars, respectively.

Biosimilarity testing using very low doses of rituximab

Biosimilars/Research | Posted 06/07/2018

Rituximab is a chimeric, monoclonal antibody directed against CD20 expressed on B lymphocytes [1]. Currently approved indications for use are non-Hodgkin lymphomas, chronic lymphatic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic angiitis [2]. However, rituximab is frequently used ‘off label’ for the treatment of numerous antibody-dependent autoimmune diseases [3].

Scientific rationale for extrapolation of cancer indications

Biosimilars/Research | Posted 07/07/2017

Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition. Once biosimilarity has been proven, biosimilars can also be approved for one or more additional indications held by the reference product, without the need for clinical data in those indications. Author Michinori Ogura from the Tokai Central Hospital, Gifu, Japan and colleagues from France and South Korea investigated the scientific rationale for extrapolation using the rituximab biosimilar CT-P10 as an example [1].

Biosimilar insulins have same efficacy and safety as reference biologicals

Biosimilars/Research | Posted 29/06/2018

Researchers from the US have found that biosimilar insulins have comparable safety and clinical efficacy as their reference biologicals [1].

Savings with use of biosimilar trastuzumab for breast cancer patients in Croatia

Biosimilars/Research | Posted 29/06/2018

Breast cancer is worldwide the most common cancer in women. In 2012 alone, there were approximately 464,000 new cases and 131,000 deaths from breast cancer in Europe. In Croatia, breast cancer was the fourth leading cause of death among women and ninth in both sexes in 2016.