Biosimilars
Innovent-Etana bevacizumab biosimilar approved in Indonesia
Innovent announced the approval of its bevacizumab biosimilar in Indonesia, that was developed in partnership with PT Etana Biotechnologies Indonesia.
Ranibizumab biosimilar, FYB201, receives EMA recommendation
Formycon’s ranibizumab biosimilar, FYB201, has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Biosimilar regulations perspective in Latin America to improve cancer treatment access
To address the issue of regulatory process of biosimilars, including intended copies*, the Americas Health Foundation (AHF) conducted a literature review and convened a panel with eight experts in biological cancer therapies and health economics to address the most salient issues concerning the regulation of biosimilars in Latin America [1].
Pegfilgrastim biosimilar Udenyca demonstrated similar immunogenicity to Neulasta
The pegfilgrastim biosimilar Udenyca (pegfilgrastim-cbqv) is a pegylated, long-acting form of filgrastim (granulocyte colony-stimulating factor [G-CSF]). It is approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a biosimilar of the originator pegfilgrastim (Neulasta) for febrile neutropenia in patients receiving myelosuppressive chemotherapy [1, 2].
Therapeutic drug monitoring with infliximab improves disease control
The latest study from the Norwegian Drug Monitoring (NORDRUM) trial [1] shows that proactive therapeutic drug monitoring (TDM) for patients receiving maintenance infliximab therapy improves disease control, compared to treatment without TDM.
New data on infliximab and adalimumab biosimilars at EULAR 2022
The Annual European Congress of Rheumatology (EULAR 2022) was held at the beginning of June 2022. This platform was used to announce the results of a study that showed that, in patients with rheumatoid arthritis, statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab. In addition, Samsung Bioepis announced new data on their established adalimumab biosimilar Imraldi (Hadlima outside Europe).
WHO revised guidelines for biosimilars: scientific background
A study carried out by Kurki P et al. in 2022 reviewed the current clinical experience and scientific evidence to provide an expert perspective for updating the World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) to increase flexibility and clarity.
EMA accepts application for high concentration adalimumab biosimilar
Sandoz, the generics division of Novartis, announced on 17 June 2022 that the European Medicines Agency (EMA) has accepted the application for its high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017).
Positive phase III results for Samsung Bioepis’ Soliris biosimilar
Samsung Bioepis announced that its biosimilar to Soliris (eculizumab) has comparable efficacy and safety and is bioequivalent to the originator.
EMA recommends approval of bevacizumab biosimilar Vegzelma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 June 2022 that it had recommended granting marketing authorization for the bevacizumab biosimilar Vegzelma.
