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Formycon and Fresenius Kabi
Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of FYB202 (Biosimilar, Stelara) 
Shots:    The CHMP has granted a positive opinion to Fresenius & Formycon’s FYB202, a biosimilar version of Stelara (ustekinumab), with the decision anticipated during Q4’24  The opinion was supported by non-clinical & clinical studies plus manufacturing data, depicting similar effectiveness, safety & PK profile of FYB202 vs Stelara among moderate to severe psoriasis vulgaris (plaque psoriasis)…
July 26, 2024
Johnson& Johnson
Johnson & Johnson’s Yuvanci (macitentan and tadalafil) Receives the CHMP’s Positive Opinion for Treating Pulmonary Arterial Hypertension (PAH) 
Shots:    The CHMP has granted positive opinion to Yuvanci [macitentan (10mg) + tadalafil (40mg)] as a substitution therapy of PAH adults, based on P-III (A DUE) study  The P-III (A DUE) trial assessed Yuvanci STCT vs macitentan (10mg) & tadalafil (40mg) alone in PAH patients (n=187). Subjects with PVR ≥240 dyn×s/cm5 randomly received M/T STCT…
July 26, 2024
Bio-Thera New
Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda)
Shots:    Bio-Thera Solutions has commenced the patients dosing under the combined P-I/P-III study evaluating BAT3306, a biosimilar version of Keytruda (pembrolizumab)  The trial aims at assessing PK profile, safety & efficacy of BAT3306 vs Keytruda among patients (n=676) with non-squamous non-small cell lung cancer (nsNSCLC)  In addition, the company is also developing biosimilars of…
July 25, 2024
Samsung Bioepis
Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)
 Shots:    The US FDA has granted approval to the company’s BLA of Epysqli (eculizumab-aagh), a biosimilar version of Soliris (eculizumab)  Approval was supported by data from the P-I trial depicting similar PK/PD, safety, tolerability & immunogenicity profiles among healthy subjects and the P-III trial showing comparable efficacy, safety, PK & immunogenicity in PNH patients b/w Epysqli vs Soliris …
July 22, 2024
STADA and Alvotech Introduces Uzpruvo (Biosimilar, Stelara) Across the EU
Shots:    The company has introduced Uzpruvo, biosimilar of Stelara (ustekinumab) across the EU to treat gastroenterology, dermatology & rheumatology indications. Uzpruvo is available in a pre-filled syringes with a thinner needle & is latex-free to avoid allergic reactions   Further EU launches are expected in the upcoming mos., pending national price approvals through a fully European supply…
July 22, 2024
 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…
July 8, 2024
Fresenius Kabi
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…
July 2, 2024
Eli Lilly
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) &…
July 2, 2024
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