Shots: Mundipharma acquires all shares of the parent company of Cinfa, Infarco including Pelmeg (pegfilgrastim, biosimilar) having global market value $4.5B The acquisition focuses on expansion of biosimilar platform by […]readmore
Tags : Biosimilar
Biosimilars
Regulatory
Celltrion and Teva Announces Approval Recommendations for CT-P10’s (rituximab, biosimilar)
Shots: FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16-0 in favor of CT-P10 and recommended it on the basis of analytical biosimilarity, nonclinical & clinical pharmacology, immunogenicity, efficacy and safety […]readmore
Biosimilars
Regulatory
Sandoz’s Biosimilar Pegfilgrastim Receives CHMP Approval for Febrile Neutropenia
Shots: The CHMP approval is based on data demonstrating analytical, preclinical, and clinical information, confirming biosimilar pegfilgrastim as a reference medicine in febrile neutropenia in terms of safety, efficacy and […]readmore
Biosimilars
Pharma
Pfizer receives EU approval for Trazimera(Trastuzumab), the First Oncology Biosimilar
Shots: Trazimera is a biosimilar of Herceptin indicated for treatment of HER2 overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma The EC approval is based on the data […]readmore
Biosimilars
Biotech
Pfizer’s Retacrit (epoetin alfa-epbx, biosimilar) Receives FDA Approval for Anemia
Shots: The approval is based on non-inferiority data demonstrating biosimilarity between Retacrit and the reference product, Epogen & Procrit In May, 2016 Pfizer and Vifor Pharma collaborated for the commercialization […]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