The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced […]readmore
Tags : Herceptin
Shots: The approval is based on P-III FeDeriCa study which involves assessing of Phesgo (SC) + CT vs Perjeta (pertuzumab, IV) & Herceptin (trastuzumab, IV) + CT in 500 patients […]readmore
Shots: The BLA is based on P-III FeDeriCa study assessing FDC of Perjeta + Herceptin (SC) + CT vs Perjeta + Herceptin (IV) + CT in 500 patients with HER2-positive […]readmore
Shots: The P-III FeDeriCa study involves assessing of SC inj. of Perjeta + Herceptin + CT vs IV infusion of Perjeta + Herceptin + CT in 500 patients with HER2+ […]readmore
Biosimilars are key alternatives for costly Biologics therapies and saving million dollars of patients in multiple diseases. Hence physicians are likely to adopt biosimilars “a reference product to biologics” possessing […]readmore
Biosimilars
Regulatory
Amgen and Allergan’s Kanjinti (biosimilar, trastuzumab) Receive the US FDA’s
Shots: The FDA’s approval is based on the totality of evidence which includes extensive comparative analytical, pharmacokinetic and clinical data demonstrating that Kanjinti is highly similar and have no clinical […]readmore
Biosimilars
Biotech
Celltrion and Teva’s Herzuma (trastuzumab-pkrb, Herceptin biosimilar) Receives FDA’s Approval
Shots: The approval is based on non-inferiority data assessing Herzuma vs Herceptin (trastuzumab), testing its safety, efficacy, PK &PD, and immunogenicity The study demonstrated with bio-similarity in terms of purity, […]readmore
Shots: The P-III KATHERINE study assessed Kadcyla vs Herceptin (trastuzumab) as an adjuvant therapy for patients with HER2-positive eBC for three years P-III KATHERINE study results: risk of disease recurrence […]readmore
Biosimilars
Regulatory
Amgen and Allergan’s ABP 980 (biosimilar, Herceptin) Receives CHMP Recommendation
Shots: The CHMP recommendation is based on P-III study results assessing ABP 980 in adult female patients with HER2-positive early breast cancer The P-III study resulted in analytical, PK, pharmacology, […]readmore