Biosimilars/Research

Analytical similarity assessment of teriparatide biosimilar Terrosa

Biosimilars/Research | Posted 10/01/2020

Terrosa and Movymia (both developed under the code name RGB-10), were the first biosimilars of Eli Lilly’s osteoporosis biological Forteo/Forsteo (teriparatide) in Europe. Gedeon Richter and Stada Arzneimittel gained European Commission approval for Terrosa and Movymia in January 2017 [1] and launched the biosimilars in August 2019 [2]. Meanwhile, RGB-10 was also approved in other countries, including Switzerland and Japan.

Positive results for Bio-Thera’s arthritis copy biologicals

Biosimilars/Research | Posted 06/09/2019

China-based Bio-Thera Pharmaceuticals have begun a phase I trial for its Simponi copy biological and obtained positive results from a phase III trial of its Humira copy biological.

Positive trial results for Lannett’s insulin biosimilar

Biosimilars/Research | Posted 17/01/2020

US firm Lannett has completed a successful trial of their candidate insulin biosimilar, which was compared to Sanofi’s blockbuster insulin product Lantus.

NeuClone progress with ustekinumab and trastuzumab biosimilars

Biosimilars/Research | Posted 10/01/2020

Australian biosimilars firm NeuClone has started a phase I trial of their proposed ustekinumab biosimilar and announced positive results from a trial of their trastuzumab biosimilar.

Pharmacists must be ready to take the lead on biosimilars

Biosimilars/Research | Posted 13/12/2019

Pharmacists should take the lead in increasing the adoption of biosimilars in clinical practice, says a review of the implications of biosimilars for pharmacy practice. The review suggests that pharmacists in all settings can take a key role in advocating for biosimilars [1].

Use of pegfilgrastim copy biological Mecapegfilgrastim in neutropenia

Biosimilars/Research | Posted 06/12/2019

Italian oncologists report on studies carried out with a new pegfilgrastim copy biological, Mecapegfilgrastim (HHPG-19K) [1].

Biosimilar education for Canadian nurses

Biosimilars/Research | Posted 29/11/2019

In general, Canadian nurses are familiar with biosimilars. However, according to authors Sehdev et al., they may have knowledge gaps in their specific understanding, resulting in a significant unmet need for education.

Brazilian efficacy and safety data for biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis

Biosimilars/Research | Posted 22/11/2019

Celltrion/Hospira’s infliximab biosimilar Remsima/Inflectra (CT-P13) was authorized by the European Medicines Agency (EMA) in 2013 [1] and by the US Food and Drug Administration (FDA) in 2016 [2].

Biologicals and biosimilar use in Asian patients with IBD

Biosimilars/Research | Posted 15/11/2019

The increasing incidence of inflammatory bowel diseases (IBD) has become a major challenge for gastroenterologists in some Asian countries, particularly China, Japan and Korea. This subject was discussed in the August 2019 issue of the Journal of Gastroenterology and Hepatology [1].

Samsung reveals positive trial results for bevacizumab biosimilar, but admits to failure with rituximab

Biosimilars/Research | Posted 15/11/2019

A phase III trial of Samsung Bioepis’ bevacizumab biosimilar has shown equivalence to reference drug Avastin (bevacizumab). However, the company has admitted to failures in its attempt to develop a rituximab biosimilar at a recent trial in the Seoul Central District Court.