Blog
RSS FeedPosted by Michael Wonder on 22 Feb 2022
Celltrion's auto-immune disease biosimilar wins further approval in Europe
22 February 2022 - South Korean pharmaceutical giant Celltrion said Tuesday that a high concentration version of its auto-immune disease ...
Posted by Michael Wonder on 14 Feb 2022
Medscape awarded contract from FDA to develop educational programming focused on biosimilars
14 February 2022 - Medscape Education has been awarded a contract from the U.S. FDA for the development of an ...
Posted by Michael Wonder on 09 Feb 2022
Nova Scotia becomes fifth Canadian province to implement a biosimilar switching program
5 February 2022 - The province is the latest jurisdiction to adopt a program that will require patients to switch ...
Posted by Michael Wonder on 04 Feb 2022
Samsung Bioepis announces Health Canada approval of 150 mg single-use vial and 440 mg multi-dose vial of Ontruzant (SB3), trastuzumab biosimilar for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer
2 February 2022 - 150 mg and 440 mg vial of Ontruzant are now approved in Canada. ...
Posted by Michael Wonder on 01 Feb 2022
Celltrion Healthcare announces Canadian approval of Yuflyma, a high concentration, low volume, citrate free and latex free Humira (adalimumab) biosimilar
31 January 2022 - Yuflyma brings a new offering to healthcare practitioners and their patients with inflammatory diseases in Canada. ...
Posted by Michael Wonder on 22 Jan 2022
Patent thickets are thwarting U.S. availability of lower cost biosimilar medicines, study finds
18 January 2022 - Amid debate over competition in the pharmaceutical industry, a new analysis found just 6% of patents ...
Posted by Michael Wonder on 13 Jan 2022
The US FDA issues a complete response letter for the biologics license application for insulin aspart
7 January 2022 - The U.S. FDA has issued a complete response letter for the biologics license application for insulin ...
Posted by Michael Wonder on 13 Jan 2022
JAMP and Alvotech announce Canadian approval of Simlandi, a high concentration biosimilar to Humira, providing access to previously unavailable versions in Canada
10 January 2021 - Health Canada rules that 40 mg/0.4 mL and 80 mg/0.8 mL presentations of Simlandi are not subject ...
Posted by Michael Wonder on 31 Dec 2021
Celltrion acquires approval for its new Humira 'Yuflyma' in Canada
30 December 2021 - Celltrion announced on December 30 that it won marketing approval from Health Canada for "Yuflyma", a ...
Posted by Michael Wonder on 26 Dec 2021
Coherus announces U.S. FDA approval of Yusimry (adalimumab-aqvh)
20 December 2021 - Approved for all eligible indications of the reference biological product, Humira (adalimumab). ...
Posted by Michael Wonder on 21 Dec 2021
Sandoz submits biologics license application for proposed biosimilar trastuzumab to US FDA
20 December 2021 - Biologics license application is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix. ...
Posted by Michael Wonder on 16 Dec 2021
AVT02, Alvotech’s biosimilar to high concentration formulation of adalimumab (Humira) approved for use in European Union
15 December 2021 - Alvotech received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira (adalimumab), from the ...
Posted by Michael Wonder on 09 Dec 2021
Henlius' fourth biologic bevacizumab biosimilar approved by National Medical Products Administration
3 December 2021 - Shanghai Henlius Biotech announced that bevacizumab biosimilar, developed and manufactured by Henlius independently, has been approved by ...
Posted by Michael Wonder on 07 Dec 2021
Biosimilar follitropin alfa on the PBS - information for health care professionals and patients
7 December 2021 - A biosimilar brand of follitropin alfa (Ovaleap) was listed on the PBS on 1 December 2021. ...
Posted by Michael Wonder on 03 Dec 2021
TOT Biopharm announces NMPA granted marketing approval for Pusintin (TAB008, bevacizumab) in China
1 December 2021 - TOT Biopharm announced its self-developed Pusintin (TAB008, bevacizumab) has been officially granted approval by the National ...