Just-Evotec Biologics and Sandoz Expand their Collaboration for Biosimilar

Shots: Just-Evotec Biologics (Evotec’s biologics segment) & Sandoz have expanded their tech collaboration to develop & manufacture biosimilars. They have been in a multi-year tech collaboration since May 2023 Under the agreement, Just-Evotec will get payment for early scientific validation along with additional funding tied to milestones from 2025 Through the expanded collaboration, Just-Evotec will…

ByDipanshu DixitJuly 8, 2024

INSIGHTS+

Insights+ Key Biosimilars Events of June 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 NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal…

ByDipanshu DixitJuly 4, 2024

NEWS

Fresenius Kabi Introduces Tyenne (Biosimilar, Actemra) Across the US

Shots: The company has introduced SC formulation of Tyenne, a biosimilar of Actemra, to treat chronic autoimmune diseases across the US. It is available in the form of prefilled syringe & an autoinjector The IV formulation of the biosimilar was introduced in Apr 2024 after the US FDA’s approval on Mar 05, 2024 Tyenne, an…

ByDipanshu DixitJuly 2, 2024

NEWS

Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer’s Disease

Shots: The approval of Kisunla (350mg/20mL, IV, QM) for early symptomatic Alzheimer's disease was based on P-III (TRAILBLAZER-ALZ 2) study. Coverage & reimbursement is available through National Coverage Determination with Coverage with Evidence Development The P-III (TRAILBLAZER-ALZ 2) trial assessed Kisunla vs PBO in patients (n=1,736) with early symptomatic AD (MCI or mild dementia) &…

ByDipanshu DixitJuly 2, 2024

NEWS

Tanvex BioPharma Reports the US FDA’s Approval of Nypozi (Biosimilar, Neupogen)

Shots: The US FDA has granted BLA approval of Nypozi (TX01), biosimilar version of Amgen’s Neupogen Nypozi (TX01) is intended to reduce the incidence of infection among patients having non-myeloid malignancies undergoing chemotherapy that may reduce neutrophil count The company’s Nypozi was introduced across Canada in Jan 2024 Ref: Tanvex BioPharma | Image: Tanvex BioPharma | Press Release…

ByDipanshu DixitJuly 1, 2024

NEWS

Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea)

Shots: The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO) The approval was based on analytical, pre-clinical, clinical and manufacturing data…

ByDipanshu DixitJune 28, 2024

NEWS

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Shots: The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability…

ByDipanshu DixitJune 28, 2024

NEWS

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Shots: The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability…

ByDipanshu DixitJune 28, 2024

NEWS

Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea)

Shots: The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO) The approval was based on analytical, pre-clinical, clinical and manufacturing data…

ByDipanshu DixitJune 28, 2024

NEWS

Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC)

Shots: The CHMP has granted a positive opinion to Balversa monotx. (QD, oral) to treat inoperable mUC adults with susceptible FGFR3 mutations & previously treated with at least 1L of therapy with PD-1/PD-L1 inhibitor The opinion was based on the arm 1 of P-III (THOR) trial assessing the safety & efficacy of erdafitinib (n=136) vs…

ByDipanshu DixitJune 28, 2024

Dipanshu Dixit

Just-Evotec Biologics and Sandoz Expand their Collaboration for Biosimilar

Insights+ Key Biosimilars Events of June 2024

Fresenius Kabi Introduces Tyenne (Biosimilar, Actemra) Across the US

Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer’s Disease

Tanvex BioPharma Reports the US FDA’s Approval of Nypozi (Biosimilar, Neupogen)

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC)

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