Blog
RSS FeedPosted by Michael Wonder on 12 Oct 2020
Efficacy trials cost more, take longer for biosimilars than originators
11 October 2020 - Average clinical efficacy testing cost millions of dollars more for Phase 3 biosimilar studies than for ...
Posted by Michael Wonder on 12 Oct 2020
Innovent and Lilly jointly announce the NMPA granted marketing approval for Halpryza (rituximab injection) in China
9 October 2020 - Innovent Biologics and Eli Lilly and Company today jointly announce that Halpryza (rituximab injection), a recombinant human/murine ...
Posted by Michael Wonder on 07 Oct 2020
Samsung Bioepis and Biogen announce EMA filing acceptance of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
6 October 2020 - Samsung Bioepis and Biogen today announced that the EMA has accepted for review the marketing authorisation Application ...
Posted by Michael Wonder on 01 Oct 2020
Centus Biotherapeutics receives European marketing authorisation for Equidacent, biosimilar Avastin
29 September 2020 - Centus Biotherapeutics, a joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca, today announced that the ...
Posted by Michael Wonder on 29 Sep 2020
Germany has not fully realised its biosimilar potential
29 September 2020 - Investigators have concluded that fully realizing the cost-saving potential of biosimilars could “release enormous resources” for ...
Posted by Michael Wonder on 21 Sep 2020
UK regulators contend biosimilar efficacy trials are redundant
19 September 2020 - Comparative biosimilar efficacy trials are unnecessary to demonstrate that drug candidates are equivalent to reference products, ...
Posted by Michael Wonder on 15 Sep 2020
Rep Grothman introduces bill for automatic insulin biosimilar interchangeablity
15 September 2020 - Representative Glenn Grothman, (R-Wisconsin), says interchangeability for insulins makes sense based on the savings potential and safety ...
Posted by Michael Wonder on 10 Sep 2020
Biosimilar pegfilgrastim on the PBS - information for health professionals and patients
11 September 2020 - A biosimilar brand of pegfilgrastim (Pelgraz) was listed on the PBS on 1 August 2020. ...
Posted by Michael Wonder on 05 Sep 2020
Biocon, Mylan launch Semglee and seek biosimilar, interchangeable status
31 August 2020 - For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to ...
Posted by Michael Wonder on 04 Sep 2020
Innovent announces NMPA granted marketing approval for Sulinno (adalimumab injection) in China
Innovent Biologics today announced that Sulinno (adalimumab injection), a recombinant human anti-TNF-α monoclonal antibody drug, has been officially approved by ...
Posted by Michael Wonder on 31 Aug 2020
A new biosimilar to NovoRapid is included in the high-cost protection
28 August 2020 - Insulin aspart Sanofi (insulin aspart) solution for injection for the treatment of diabetes is included in ...
Posted by Michael Wonder on 27 Aug 2020
Mylan, Lupin launch etanercept biosimilar in Germany
26 August 2020 - The launch marks the first European market entry for Nepexto. ...
Posted by Michael Wonder on 21 Aug 2020
Samsung Bioepis receives European Commission approval for Aynbintio (bevacizumab)
20 August 2020 - Aybintio is Samsung Bioepis’ fifth biosimilar to be approved by the European Commission. ...
Posted by Michael Wonder on 19 Aug 2020
Launch of two biosimilars
19 August 2020 - Sandoz Canada announces an agreement with the pCPA and the launches of Ziextenzo and Riximyo. ...
Posted by Michael Wonder on 18 Aug 2020
China's first trastuzumab biosimilar approved by NMPA
17 August 2020 - Shanghai Henlius Biotech announced on 14 August that the trastuzumab biosimilar HLX02, developed and manufactured by Henlius ...