Tags : Herceptin

Top 20 Prescription Drugs Based on 2019 Revenue

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 for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More

Roche Reports Acceptance of BLA for Fixed-Dose SC Combination of

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 eBC who are being treated in the neoadjuvant & adjuvant settings The P-III FeDeriCa study resulted in meeting its 1EPs & 2EPs i.e. non-inferior levels […]Read More

Insights+ Key Biosimilars Events of August 2019

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 similar therapeutic properties in terms of potency, safety, and efficacy to original biologic products. Our team at PharmaShots has summarized key events of biosimilar space […]Read More

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 differences from Roche’s Herceptin Kanjinti is the second biosimilar from Amgen and Allergan’s collaboration and third biosimilar from the Amgen’s portfolio to receive FDA’s approval […]Read More

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, potency and safety between Herzuma and Herceptin in patients with HER2-overexpressing breast cancer Herceptin biosimilar, Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist, approved by the […]Read More

Roche Reports Results of Kadcyla (trastuzumab emtansine) in P-III KATHERINE

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 or death 50%; didn’t have breast cancer return (88.3% vs 77.0%); with no new safety issues Kadcyla is an antibody-drug conjugate (ADC) developed for delivering […]Read More

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, toxicology data with efficacy, safety and immunogenicity in patients ABP 980 (trastuzumab) is a recombinant DNA-derived mIgG1 kappa Ab indicated for HER2-overexpressing early BC, adjuvant […]Read More