Biosimilars
ASCO/ASH give recommendations for biosimilar ESAs
Recommendations for biosimilar erythropoiesis-stimulating agents (ESAs) in the management of cancer-associated anaemia have been issued by the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH).
Biosimilars education still needed for US and EU clinicians
A review of the literature has concluded that healthcare providers are still cautious when it comes to biosimilars and that clinician-directed education is still needed to increase biosimilar knowledge, facilitate prescribing changes and increase use of biosimilars [1].
EMA approval for pegfilgrastim biosimilar Grasustek
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended the granting of a marketing authorization for the pegfilgrastim biosimilar Grasustek.
Patient and provider views on biosimilars to treat breast cancer
A Canadian breast cancer advocacy group collected insights from patients and medical oncologists regarding the use of biosimilar treatments.
Pharmacokinetic assessment of biosimilar therapeutic monoclonal antibodies
Comparison of the clinical pharmacokinetic (PK) profile of a biosimilar with that of the reference product is an important step in the development of biosimilars. In a recent review, Ishii-Watabe and Kuwabara outline key considerations for the comparative studies required for biosimilar development, focusing on the clinical PK profiles of biosimilar therapeutic monoclonal antibodies (mAbs) and their reference products [1].
FDA approves etanercept biosimilar Eticovo
Korean biosimilars maker Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 25 April 2019 that it had received approval from the US Food and Drug Administration (FDA) for its etanercept biosimilar.
ASCO/ASH update ESA recommendations
The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) have updated their recommendations on the management of cancer-associated anaemia with erythropoiesis-stimulating agents (ESAs).
Biosimilar comparability assessment
In a recent review, Ishii-Watabe and Kuwabara summarize the principles of biosimilar development and outline key considerations for studies comparing a biosimilar with its reference product [1].
FDA to hold public meeting on access to affordable insulin
The US Food and Drug Administration (FDA) is seeking input on the challenges and opportunities the agency should consider as it prepares for the submission and review of applications for biosimilar and interchangeable insulin products, as well as about the development process for such products.
Comparability of biosimilar Ontruzant maintained over three years
Samsung Bioepis has presented positive long-term results for its trastuzumab biosimilar Ontruzant (SB3) at the 16th International Maternal Cancer Congress St Gallen 2019, which was held in Vienna, Austria.
