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Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

Amgen v Hospira: BPCIA dance lessons in the Federal Circuit

By Naomi Pearce | Aug 22, 2017

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Just over a week ago, the US Federal Circuit provided BPCIA “dance lessons” for reference product sponsors and biosimilar applicants, as it handed down its decision in Amgen v Hospi...
Sandoz launches Erelzi® in Canada

By Bioblast Editor | Aug 21, 2017

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Sandoz launches Erelzi® in Canada.
Biocon/Mylan withdraw EU applications

By Bioblast Editor | Aug 16, 2017

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Biocon/Mylan withdraw EU applications for biosimilar trastuzumab & pegfilgrastim.
AbbVie commences BPCIA proceedings against Boehringer Ingelheim

By Bioblast Editor | Aug 02, 2017

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AbbVie commences BPCIA proceedings against Boehringer Ingelheim for Humira® (adalimumab) biosimilar in the District Court of Delaware, alleging infringement of 8 patents: (8,926,975; 9,018,361; 9,090,867; 9,096,666; 9,255,143; 9,266,949; 9,272,041; and 9,546,212), a subset ...
TGA seeks input on biosimilar naming in Australia

By Naomi Pearce | Aug 01, 2017

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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...
Celltrion and Mundipharma disclose financial impact of Truxima®

By Bioblast Editor | Aug 01, 2017

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Celltrion/Mundipharma claim their biosimilar rituximab (Truxima®) has 30% of total EU market due to rapid growth.
MSD's Renflexis® becomes PBS listed

By Bioblast Editor | Aug 01, 2017

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MSD’s biosimilar infliximab (Renflexis®), co-developed with Samsung Bioepis, is the second biosimilar to be PBS listed in Australia.
Amgen and Allergan files BLA for biosimilar trastuzumab

By Bioblast Editor | Jul 31, 2017

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Amgen and Allergan announce BLA filing for ABP980, biosimilar trastuzumab.
FDA reviews Celltrion & Teva BLA for biosimilar Herceptin®

By Bioblast Editor | Jul 31, 2017

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Celltrion & Teva announce the FDA has accepted for review their BLA for CT-P6, biosimilar Herceptin® (INN: trastuzumab).
Boehringer Ingelheim commences AmAb interchangeability studies

By Bioblast Editor | Jul 28, 2017

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BI commences interchangeability studies between biosimilar BI695501 and Humira 40mg/0.8ml, with the results expected in second half of 2019.