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Fresenius Kabi
NEWS

Fresenius Kabi’s Otulfi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since March 2025 FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…
May 20, 2025

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NEWS

Formycon Reports the MHRA’s Approval of FYB203 (Biosimilar, Eylea) as Ahzantive

Shots: Following the EC approval, Formycon & Klinge Biopharma have reported the UK MHRA’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand name: Ahzantive The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal…
February 25, 2025

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Lotus Pharma & Formycon
NEWS

Lotus Pharmaceutical and Formycon Enter into a Strategic Partnership to Commercialize FYB203/Ahzantive (Biosimilar, Eylea) in APAC

Shots: Formycon has signed an exclusive license agreement with Lotus Pharmaceutical to commercialize FYB203/Ahzantive in APAC countries, including Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, and Hong Kong. Additionally, Formycon will supply the finished product to Lotus As per the agreement, Klinge will receive upfront and milestone payments, along with royalties on Lotus’ net…
February 5, 2025

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NEWS

Formycon Reports the EC’s Approval of FYB203 (Biosimilar, Eylea) Under the Brand Names Ahzantive and Baiama

Shots: Formycon & Klinge Biopharma have reported the EC’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand names: Ahzantive & Baiama valid across the EU plus Iceland, Liechtenstein & Norway after receiving the CHMP’s recommendation in Nov 2024 The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other…
January 21, 2025

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NEWS

Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel

Shots: Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a…
January 14, 2025

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Insights+ Key Biosimilars Events of July 2024
INSIGHTS+

Insights+ Key Biosimilars Events of July 2024

Shots:     Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency      Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients      The major highlights were the US FDA’s approval of Samsung Bioepis’ Epysqli for Treating Paroxysmal…
August 1, 2024

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Insights+ Key Biosimilars Events of September 2023
INSIGHTS+

Insights+ Key Biosimilars Events of September 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients During the month of September, Sandoz entered into a development and commercialization agreement…
October 4, 2023

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Insights+ Key Biosimilars Events of August 2023
INSIGHTS+

Insights+ Key Biosimilars Events of August 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients During the month of August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…
September 6, 2023

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