Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 29 Nov 2021
Biosimilar industry vets critique Biden's drug pricing reforms
29 November 2021 - Specialty tiers for biosimilars and reforms that address the proliferation of poor quality patents would help ...
Posted by Michael Wonder on 23 Nov 2021
The BBB’s threat to biosimilar drug development
23 November 2021 - In 2019, longtime pharmaceutical industry critic, Peter Bach, took to the Wall Street Journal to declare that ...
Posted by Michael Wonder on 16 Nov 2021
PHARMAC widens access to adalimumab through transition to biosimilar
17 November 2021 - Pharmac’s chief medical officer Dr David Hughes has today announced the decision to fund a biosimilar adalimumab ...
Posted by Michael Wonder on 16 Nov 2021
Viatris and Biocon Biologics announce launch of interchangeable Semglee (insulin glargine-yfgn) injection and insulin glargine (insulin glargine-yfgn) injection
16 November 2021 - Branded and unbranded versions of the first-ever interchangeable biosimilar in the U.S. provide more affordable options for ...
Posted by Michael Wonder on 11 Nov 2021
FDA touts success and challenges in biosimilar development
10 November 2021 - A top official from the US FDA offered a mixed assessment of the agency’s biosimilars program, noting ...
Posted by Michael Wonder on 11 Nov 2021
Patient access to affordable cancer treatment increases with the launch of new biosimilar in Canada
9 November 2021 - Apobiologix today launched its first oncology therapeutic treatment Bambevi (bevacizumab), which is used in combination with ...