Biosimilars/News
Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars
In August 2024, Henlius Biotech's trastuzumab biosimilar, Adheroza, received marketing approval from Health Canada. In July 2024, Celltrion’s ustekinumab biosimilar, Steqeyma (CT-P43), also gained Health Canada approval.
EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars
On 25 July 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for three more monoclonal antibody biosimilars: ranibizumab, rituximab, and trastuzumab.
COFEPRIS approves bevacizumab Bhava and trastuzumab Mamitra biocomparables
In July 2024, the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk, Comisión Federal para la Protección contra Riesgos Sanitarios), approved two biocomparables – bevacizumab Bhava and trastuzumab Mamitra – from India-based Zydus.
EMA recommends approval of four ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi, Steqeyma
On 25 July and 27 June 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of marketing authorization for four ustekinumab biosimilars.
FDA approves filgrastim biosimilar Nypozi
In addition to the biosimilars approval of Pyzchiva (ustekinumab-ttwe), with a provisional determination for interchangeability designation [1], and Ahzantive (aflibercept-mrbb) [2] on 28 June 2024, the US Food and Drug Administration (FDA) also approved Tanvex BioPharma’s Nypozi (filgrastim-txid) biosimilar, which references Amgen’s Neupogen.
FDA approves third aflibercept biosimilar Ahzantive
The US Food and Drug Administration (FDA) was busy in June 2024. On 28 June 2024, the FDA granted approval for Formycon’s Ahzantive (aflibercept-mrbb), making it the third approval for a biosimilar referencing Eylea.
Richmond to launch similar biologicals bevacizumab Yriviak and adalimumab Armixa
On 22 July 2024, the Argentina-based Laboratorios Richmond announced the launch of Yriviak, a bevacizumab similar biological, in Argentina. In the coming months, Richmond plans to launch their adalimumab similar biological, Armixa.
China approves Simcare’s cetuximab beta Enlituo
On 25 June 2024, Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group based in Nanjing, China, announced that Enlituo, a cetuximab beta injection, had received marketing approval from the China National Medical Administration (NMPA). This new-generation anti-epidermal growth factor receptor (EGFR) antibody drug was developed in collaboration with Mabpharm Limited.
FDA approves third ustekinumab biosimilar Pyzchiva
On 28 June 2024, the US Food and Drug Administration (FDA) approved a third ustekinumab biosimilar, Pyzchiva (ustekinumab-ttwe). This product has been developed by Samsung Bioepis and is commercialised by Sandoz. It is a biosimilar of reference product Johnson & Johnson’s (J&J) Stelera.
FDA approves first eculizumab biosimilar Bkemv for two rare diseases
On 28 May 2024, the US Food and Drug Administration (FDA) approved Amgen's Bkemv (eculizumab-aeeb), the first biosimilar to AstraZeneca's rare blood disorder treatment Soliris approved in the US.
