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RSS FeedPosted by Michael Wonder on 29 May 2024
FDA approves first interchangeable biosimilar for two rare diseases
28 May 2024 - Today, the US FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to ...
Posted by Michael Wonder on 28 May 2024
Fresenius announces FDA acceptance for review of denosumab biosimilar application
27 May 2024 - Fresenius announced today that the US FDA has accepted for review the company’s biologics license application ...
Posted by Michael Wonder on 25 May 2024
EMA validates Henlius and Organon filings for Prolia and Xgeva (denosumab) biosimilar candidate HLX14
24 May 2024 - Shanghai Henlius Biotech and Organon today announced that the EMA has validated the marketing authorisation applications for ...
Posted by Michael Wonder on 25 May 2024
Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe
23 May 2024 - The European Commission decision is based on clinical evidence, including results from a Phase 3 clinical trial ...
Posted by Michael Wonder on 22 May 2024
Sandoz receives European Commission approval for Wyost and Jubbonti, the first and only biosimilars of denosumab in Europe
22 May 2024 - EC approval based on robust development program confirming that biosimilar matches reference medicine in terms of ...
Posted by Michael Wonder on 21 May 2024
Teva and Alvotech announce Simlandi (adalimumab-ryvk) injection now available in the US
20 May 2024 - Simlandi is the first interchangeable high concentration, citrate-free biosimilar to Humira. ...
Posted by Michael Wonder on 20 May 2024
FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions
20 May 2024 - Today, FDA approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercecpt-yszy) as the first interchangeable biosimilars to Eylea (aflibercept). ...
Posted 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 ...