Blog
RSS FeedPosted by Michael Wonder on 26 Apr 2023
Celltrion seeks approval for Xolair biosimilar in EU
25 April 2023 - Celltrion said it has completed a marketing authorization application for CT-P39, a biosimilar referencing Xolair (omalizumab) ...
Posted by Michael Wonder on 12 Apr 2023
ASCO policy statement on biosimilar and interchangeable products in oncology
12 April 2023 - Given the current market dynamics and the regulatory landscape, this ASCO manuscript now seeks to propose several ...
Posted by Michael Wonder on 08 Apr 2023
Accord BioPharma announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
5 April 2023 - The biosimilar for Herceptin seeks to treat several forms of HER2 cancer. ...
Posted by Michael Wonder on 03 Apr 2023
Sandoz receives approval by European Commission for Hyrimoz (adalimumab) high-concentration formulation
3 April 2023 - Biosimilar Hyrimoz (adalimumab) citrate free high concentration formulation is now approved in the EU for use in ...
Posted by Michael Wonder on 02 Apr 2023
Samsung Bioepis receives positive CHMP opinion for eculizumab biosimilar, Epysqli
31 March 2023 - Epysqli, a biosimilar referencing Soliris (eculizumab), is Samsung Bioepis’ first biosimilar in haematology to be recommended for ...
Posted by Michael Wonder on 22 Mar 2023
Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 March 2023 - Biosimilar Hyrimoz (adalimumab-adaz) high-concentration formulation approved for seven indications of reference medicine Humira. ...
Posted by Michael Wonder on 22 Mar 2023
Techdow USA announces FDA approval of generic Lovenox (enoxaparin sodium – preservative free) in pre-filled syringes
20 March 2023 - Techdow today announced the FDA approval of enoxaparin sodium (preservative free) in pre-filled syringes for the US ...
Posted by Michael Wonder on 09 Mar 2023
Samsung Bioepis launches Lucentis biosimilar in Canada, Germany
5 March 2023 - According to industry sources on Sunday, SB11 was introduced to the Canadian market last Wednesday through its ...
Posted by Michael Wonder on 02 Mar 2023
FDA and FTC collaborate to advance competition in the biologic marketplace
2 March 2023 - In 2021 alone, the US spent $256 billion on biologics. Although biologics comprise approximately 3% of prescriptions ...
Posted by Michael Wonder on 27 Feb 2023
Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma (CT-P17), in the US, saying there were some problems, but they have been solved now
24 February 2023 - Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma ...
Posted by Michael Wonder on 16 Feb 2023
Stimufend (pegfilgrastim-fpgk) now available in the United States
16 February 2023 - Fresenius Kabi introduces its first biosimilar in the US. ...
Posted by Michael Wonder on 15 Feb 2023
Henlius announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
14 February 2023 - The first Chinese biosimilar approved in both China and the EU, and potentially to be approved in ...
Posted by Michael Wonder on 13 Feb 2023
Amgen pricing for its Humira biosimilar may benefit PBMs and insurers more than patients
31 January 2023 - Underscoring the opaque and confusing nature of pharmaceutical pricing, Amgen announced long-awaited discounts for its biosimilar ...
Posted by Michael Wonder on 09 Feb 2023
EMA confirms acceptance of application for AVT04, a proposed biosimilar to Stelara (ustekinumab)
9 February 2023 - EMA opinion on AVT04 could come as soon as the second half of 2023. ...
Posted by Michael Wonder on 06 Feb 2023
Sandoz biologics license application for proposed biosimilar denosumab accepted by US FDA
6 February 2023 - Submission supported by comprehensive analytical and clinical data package. ...