Clinical

A new paper describes the process of assessing the analytical and functional similarity of EU- and US-licensed reference trastuzumab and Amgen's ABP 980, Kanjinti. 
Genor Biopharma, a China-based drug developer that is engaged in development of a number of biosimilars, has completed a phase 1 study of a proposed infliximab biosimilar, GB242, referencing Remicade.
While the United States awaits the launch of its first biosimilar rituximab, other regulatory jurisdictions have biosimilars referencing Rituxan already available on the market. One such product, available in South America, the Middle East, and Africa, is RTXM83, developed by drug maker mAbxience.
The Center for Biosimilars® recaps the top news for the week of April 8, 2019.
Between reference infliximab and biosimilar infliximab CT-P13 (Inflectra, Remsima), different recommendations exist for the clinical solutions. Recently, a research article, published in BioDrugs, assessed and compared the stability of the solutions prepared from the originator and the biosimilar using a set of characterization methods in line with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use recommendations.
During this week’s 21st Congress of the Asia Pacific League of Associations for Rheumatology and Australian Rheumatology Association, held April 8-11 in Brisbane, Australia, multiple groups of researchers are reporting on the real-world use of biosimilars in rheumatology. According to these research teams, biosimilars are proving to be effective in the real-world clinical setting.
This week, rheumatology experts will gather in Brisbane, Australia, for the 21st Congress of the Asia Pacific League of Associations for Rheumatology (APLAR) and Australian Rheumatology Association (ARA), held April 8-11. During the meeting, several groups of researchers will discuss real-world experience with biosimilar infliximab in Asia.
The study is an open-label extension of a phase 3 trial that included 68 weeks of treatment with the biosimilar adalimumab, Amjevita, followed by an assessment visit at week 70 and an end-of-study visit at week 72.
Biosana Pty Ltd, a subsidiary of BiosanaPharma BV, says it received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase 1 trial for a biosimilar version of omalizumab.
The Center for Biosimilars® recaps the top news for the week of April 1, 2019.

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