Blog
RSS FeedPosted by Michael Wonder on 01 Sep 2023
Celltrion applies for Australian approval for Stelara biosimilar
31 August 2023 - Celltrion said it has completed a marketing authorisation application for CT-P43, a biosimilar referencing Stelara (ustekinumab) ...
Posted by Michael Wonder on 26 Jul 2022
Henlius Hanquyou received TGA approval in Australia
26 July 2022 - Shanghai Henlius Biotech announced that the company's business partner Cipla has received the relevant registration certificates from ...
Posted by Michael Wonder on 16 May 2022
Pfizer settles two lawsuits, starts another over etanercept biosimilar in Australia
17 May 2022 - After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit ...
Posted by Michael Wonder on 08 Apr 2022
TGA approved Yuflyma
8 April 2022 - The TGA has approved yet another adalimumab biosimilar. ...
Posted by Michael Wonder on 03 Aug 2018
Celltrion’s biosimilar Herzuma approved in Australia
2 August 2018 - Korean biopharmaceutical firm Celltrion said on 2 August that its breast cancer biosimilar has been approved ...
Posted by Michael Wonder on 27 Jun 2018
Sandoz restrained from selling MabThera biosimilar in Australia
21 June 2018 - Australia's first biosimilar interlocutory injunction. ...
Posted by Michael Wonder on 23 Apr 2018
Celltrion’s Truxima approved in Australia
20 April 2018 - Celltrion said Sunday it has recently won approval from the Australia's Therapeutic Goods Administration for the ...
Posted by Michael Wonder on 28 Mar 2018
Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine
27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation ...
Posted by Michael Wonder on 22 Feb 2018
Biosimilar medicines regulation
22 February 2018 - This guidance assists sponsors of biosimilar medicines to complete an application to register their medicine on the ...
Posted by Michael Wonder on 01 Feb 2018
TGA approves first Humira biosimilar
1 February 2018 - Hadlima was registered by the TGA on 24 January 2018. ...
Posted by Michael Wonder on 01 Aug 2017
Nomenclature of biological medicines
28 July 2017 - The TGA is seeking comments from interested parties on proposed options on whether there is a need ...
Posted by Michael Wonder on 13 Jun 2017
Generic and biosimilar prescription medicines, 2016
13 June 2017 -The generic and biosimilar prescription medicines: TGA annual summary 2016 publication provides details of all generic and ...
Posted by Michael Wonder on 02 May 2017
MSD plans 2017 launch of Renflexis (infliximab) in Australia
1 May 2017 - Latest MSD biosimilar secures TGA approval. ...
Posted by Michael Wonder on 30 Sep 2016
Fast-track approval of medicines in Australia
30 September 2016 - The Australian Government has recently taken steps to fast track the registration of new medicines, generics, and ...
Posted by Michael Wonder on 28 Jul 2016
TGA approves Brenzys (etanercept)
28 July 2016 - The TGA has approved a biosimilar to Pfizer's Enbrel. ...