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RSS FeedPosted by Michael Wonder on 13 May 2024
Boehringer Ingelheim expands access to adalimumab-adbm injection, the company's biosimilar to Humira
13 May 2024 - Boehringer Ingelheim announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient ...
Posted by Michael Wonder on 10 May 2024
Celltrion USA's adalimumab-aaty biosimilar to Humira now available at low wholesale acquisition cost
9 May 2024 - Adalimumab-aaty will be priced at an 85% discount to Humira (adalimumab). ...
Posted by Michael Wonder on 02 May 2024
US FDA approves high concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable biosimilar to Humira
1 May 2024 - Boehringer Ingelheim announced today that the US FDA has approved the high concentration, citrate-free formulation of ...
Posted by Michael Wonder on 29 Apr 2024
Evernorth announces Humira biosimilar available at $0 out of pocket for Accredo patients in June
25 April 2024 - Biosimilar price will be about 85% lower than Humira. ...
Posted by Michael Wonder on 27 Apr 2024
A milestone in facilitating the development of safe and effective biosimilars
26 April 2024 - This week, the FDA approved the 50th biosimilar, reflecting the markedly increased availability of biosimilar products—products that ...
Posted by Michael Wonder on 27 Apr 2024
Biogen receives positive CHMP opinion for Tofidence (tocilizumab), a biosimilar referencing RoActemra
25 April 2024 - CHMP positive opinion is based on a robust analytical, non-clinical and clinical data package comparing Tofidence ...
Posted by Michael Wonder on 23 Apr 2024
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s ...
Posted by Michael Wonder on 22 Apr 2024
Alvotech signs US agreement to expand access for newly approved high concentration interchangeable biosimilar to Humira (adalimumab)
19 April 2024 - Alvotech, in agreement with Teva Pharmaceuticals, has signed an agreement with a strategic partner to bring to ...
Posted by Michael Wonder on 22 Apr 2024
Sandoz confirms European Commission approval of Pyzchiva (ustekinumab), further strengthening immunology offering
22 April 2024 - EC approval based on robust development program confirming match to reference medicine in terms of safety, ...
Posted by Michael Wonder on 20 Apr 2024
Nora Pharma receives Health Canada approval for Niopeg, a biosimilar of Neulasta
19 April 2024 - Nora Pharma, a wholly owned division of Sunshine Biopharma, has received approval from Health Canada for the ...
Posted by Michael Wonder on 18 Apr 2024
Alvotech and Teva announce US FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)
16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...
Posted by Michael Wonder on 12 Apr 2024
Formycon announces commercial launch of FYB201 (ranibizumab) in Canada (Ranopto) and Switzerland (Ranivisio)
11 April 2024 - Commercialization partner Teva markets FYB201 in Canada under the trademark Ranopto and in Switzerland under the trademark ...
Posted by Michael Wonder on 18 Mar 2024
Zymfentra (infliximab-dyyb), the first and only FDA approved subcutaneous infliximab, now commercially available in the U.S.
17 March 2024 - Zymfentra is commercially available across the US on 15 March 2024. ...
Posted by Michael Wonder on 11 Mar 2024
Celltrion USA completes submission of biologics license application to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab)
10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...
Posted by Michael Wonder on 09 Mar 2024
Fresenius Kabi’s biosimilar Tyenne (tocilizumab-aazg) becomes the first intravenous and subcutaneous tocilizumab biosimilar approved by the FDA
7 March 2024 - Fresenius Kabi announced today that the US FDA has approved Tyenne (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra ...