The TGA consultation paper can be found here.
The TGA paper outlines the biosimilar naming conventions implemented in EU (INN), Japan (BSn), and the planned US 4 letter biolog...
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By Naomi Pearce | Aug 01, 2017
The TGA consultation paper can be found here.
The TGA paper outlines the biosimilar naming conventions implemented in EU (INN), Japan (BSn), and the planned US 4 letter biolog...
By Bioblast Editor | Aug 01, 2017
Celltrion/Mundipharma claim their biosimilar rituximab (Truxima®) has 30% of total EU market due to rapid growth.
By Bioblast Editor | Aug 01, 2017
MSD’s biosimilar infliximab (Renflexis®), co-developed with Samsung Bioepis, is the second biosimilar to be PBS listed in Australia.
By Bioblast Editor | Jul 31, 2017
Amgen and Allergan announce BLA filing for ABP980, biosimilar trastuzumab.
By Bioblast Editor | Jul 31, 2017
Celltrion & Teva announce the FDA has accepted for review their BLA for CT-P6, biosimilar Herceptin® (INN: trastuzumab).
By Bioblast Editor | Jul 28, 2017
BI commences interchangeability studies between biosimilar BI695501 and Humira 40mg/0.8ml, with the results expected in second half of 2019.
By Bioblast Editor | Jul 27, 2017
PTAB instituted IPR on 3 of Hospira’s 5 IPR requests relating to trastuzumab. The Board instituted IPR of the following patents: 7,371,379 (IPR2017-00805), 6,627,196 (IPR2017-00804), and 7,892,549 (IPR2017-00737). IPR was denied against 7,892,549 (IPR2017-00739) and 7,846,...
By Bioblast Editor | Jul 24, 2017
Samsung Biopeis launches Renflexis® , biosimilar to J&J’s Remicade® in the US following its April approval in the US.
By Bioblast Editor | Jul 21, 2017
Korean BIOCND shares its plans to complete the phase 1 clinical trials of Lucentis biosimilar (BCD 300) by the end of 2017 and then will seek a partner.
By Bioblast Editor | Jul 17, 2017
Celltrion to commence ph 1 clinical trials for biosimilar bevacizumab in South Korea. Read more
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