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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…
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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…
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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) &…
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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…
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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…
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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…
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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…
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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…
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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…
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The CHMP has granted a positive opinion for conditional marketing authorization of odronextamab (CD20xCD3 bispecific Ab) to treat r/r FL or r/r DLBCL post ≥2L of therapies, with the EC’s decision anticipated in the upcoming mos.
The opinion was based on the P-I (ELM-1) & pivotal P-II (ELM-2) studies, showing strong durable response rates…

