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NEWS

Accord BioPharma’s Hercessi (Biosimilar, Herceptin) Receives the US FDA Approval

Shots:  Accord BioPharma's Hercessi (trastuzumab-strf; 150mg; IV), a biosimilar to Herceptin (trastuzumab), has been approved by the US FDA to treat HER2 overexpressing breast and G/GEJ cancer in the US  The approval was based on 2 studies incl. P-I (HLX02-HV01 & HLX02-HV02) trial assessing the single-dose, PK equivalence in healthy volunteers. P-III (HLX02-BC01) trial assessing…
April 29, 2024

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NEWS

Alvotech and Teva Pharmaceuticals Collaborate to Expand Access for Adalimumab-ryvk (Interchangeable Biosimilar, Humaira) in US

Shots:  Alvotech entered into a long-term agreement with Teva Pharmaceuticals to expand access to newly US FDA-approved higher concentration Adalimumab-ryvk, an interchangeable biosimilar to Humaira in US market  The partnership agreement aims to broaden access and further availability assurance of biologics for patients at affordable prices in the US and globally  Following commercialization collaboration between…
April 16, 2024

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Bio-Thera Solutions and SteinCares Collaborate for Marketing Biosimilars Across LATAM 

Shots:  Bio-Thera Solutions and SteinCares have entered into a new licensing agreement for marketing two biosimilars as per which SteinCares gains exclusive distribution and marketing rights to Bio-Thera's products across Brazil and the rest of the region  Under the agreement, Bio-Thera will handle the biosimilars’ development & regulatory submissions with the US FDA & the…
March 18, 2024

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Fresenius Kabi
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Fresenius Kabi Reports the US FDA’s Approval for Tyenne (Biosimilar, tocilizumab-aazg) as a Treatment of Immunological and Oncological Indications 

Shots:  The US FDA approved Fresenius’ Tyenne (tocilizumab-aazg) developed as a biosimilar version of Actemra (tocilizumab)   According to the patent settlement agreement signed between Fresenius Kabi and Genentech for Tyenne, Fresenius has the license to market its tocilizumab products across the US as per the undisclosed licensing dates   Tyenne functions as an Interleukin-6 (IL-6) receptor…
March 7, 2024

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NEWS

Alvotech and Teva’s Simlandi (Biosimilar, Humira) Receives the US FDA’s Approval for the Treatment of Multiple Indications 

Shots:  The US FDA has approved Simlandi injection for treating adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa & uveitis as well as juvenile idiopathic arthritis & Crohn's Disease  The approval was based on a series of studies incl. P-I (AVT02-GL-101) trial comparing the PK, safety & tolerability in…
February 23, 2024

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NEWS

Coherus BioSciences Launches an On Body Injector for the Administration of Udenyca (biosimiolar, pegfilgrastim) to Treat Non-Myeloid Malignancies

Shots:   The US FDA approved Udenyca Onbody earlier in Dec 2023, as an OBI device to administer Udenyca, a biosimilar of pegfilgrastim. The company has launched Udenyca in the US market for the treatment of patients with non-myeloid malignancies    Udencya is a leukocyte growth factor indicated to be administered the day after CT to lower the rate…
February 21, 2024

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