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RSS FeedPosted by Michael Wonder on 08 Dec 2023
Health Canada approves FYB201/Ranopto (ranibizumab), a biosimilar to Lucentis
7 December 2023 - Formycon, Polpharma Biologics, Bioeq and Teva Canada jointly announce that Health Canada has granted the Notice ...
Posted by Michael Wonder on 04 Dec 2023
Celltrion submits application for FDA approval of Prolia biosimilar CT-P41
4 December 2023 - Celltrion announced on 30 November (local time) that it has completed the application for product licensing ...
Posted by Michael Wonder on 30 Nov 2023
Formycon and Fresenius Kabi announce file acceptance for FYB202, a biosimilar candidate to Stelara (ustekinumab), by the US FDA
30 November 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the US FDA has accepted the biologics ...
Posted by Michael Wonder on 27 Nov 2023
Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea (aflibercept)
27 November 2023 - Formycon and its license partner Klinge Biopharma announce that the marketing authorisation application for FYB203, a biosimilar ...
Posted by Michael Wonder on 21 Nov 2023
Sandoz launches Hyrimoz (adalimumab) high concentration formulation in Europe, aiming to improve patient care
21 November 2023 - Hyrimoz HCF to launch progressively across Europe. ...
Posted by Michael Wonder on 20 Nov 2023
Teva announces approval of a generic version of Forteo (teriparatide injection) in the US
17 November 2023 - Forteo (teriparatide injection) is indicated to treat osteoporosis among certain women and men.
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Posted by Michael Wonder on 14 Nov 2023
Biocon Biologics receives UK (MHRA) approval for Yesafili, biosimilar aflibercept
13 November 2023 - Biocon Biologics has announced that MHRA in the UK has granted marketing authorisation for Yesafili, a biosimilar ...
Posted by Michael Wonder on 13 Nov 2023
In shocking reversal, CMS wants to allow Medicare Part D plan sponsors to substitute non-interchangeable biosimilars
10 November 2023 - On November 6, 2023, CMS announced a proposed Rule that would permit Medicare Part D plan sponsors ...
Posted by Michael Wonder on 10 Nov 2023
STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara
10 November 2023 - CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within ...
Posted by Michael Wonder on 08 Nov 2023
Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira
7 November 2023 - Supplemental biologics license application based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: ...
Posted by Michael Wonder on 02 Nov 2023
HHS Secretary Becerra's statement on the FDA’s approval of Wezlana
31 October 2023 - Today, US Department of Health and Human Services Secretary Xavier Becerra released the following statement regarding ...
Posted by Michael Wonder on 31 Oct 2023
FDA approves interchangeable biosimilar for multiple inflammatory diseases
31 October 2023 - Today, the US FDA approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) ...
Posted by Michael Wonder on 30 Oct 2023
Celltrion USA announces distribution and incorporation of Yuflyma (adalimumab-aaty), a Humira biosimilar, to CarePartners Specialty Pharmacy Cost Savings Programs
26 October 2023 - The treatment will be available on CarePartners Specialty Pharmacy Program in late October and will make ...
Posted by Michael Wonder on 27 Oct 2023
Organon Canada announces availability of a high concentration, citrate free formulation of Hadlima, a biosimilar to Humira
26 October 2023 - Hadlima 40 mg/0.4 mL offers a higher concentration compared to Hadlima 40 mg/0.8 mL. ...
Posted by Michael Wonder on 23 Oct 2023
Celltrion USA announces US FDA approval of Zymfentra (infliximab-dyyb), the first and only subcutaneous infliximab, for the treatment of people with inflammatory bowel disease
22 October 2023 - Zymfentra is the first and only FDA approved subcutaneous formulation of infliximab approved for the maintenance treatment ...