Biosimilars/News

FDA approves aflibercept biosimilars Enzeevu and Pavblu

Biosimilars/News | Posted 15/10/2024

The US Food and Drug Administration (FDA) has approved two more aflibercept biosimilars in August 2024. The FDA granted approval for Sandoz’s Enzeevu (aflibercept-abzv) and Amgen’s Pavblu (aflibercept-ayyh) on 12 and 23 August 2024, respectively, making them the fourth and fifth approvals for a biosimilar referencing Eylea.

EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma

Biosimilars/News | Posted 08/10/2024

The European Commission (EC) granted marketing authorization for four biosimilars between June and August 2024. In August 2024, the EC approved Celltrion’s SteQeyma (ustekinumab), in July 2024, Bio-Thera’s Avzivi (bevacizumab), and in June 2024, Amgen’s Wezenla (ustekinumab) and Biogen/Bio-Thera’s Tofidence (tocilizumab).

Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars

Biosimilars/News | Posted 01/10/2024

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

Biosimilars/News | Posted 24/09/2024

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

Biosimilars/News | Posted 18/09/2024

In July 2024, the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary RiskComisión 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

Biosimilars/News | Posted 10/09/2024

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

Biosimilars/News | Posted 04/09/2024

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

Biosimilars/News | Posted 13/08/2024

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

Biosimilars/News | Posted 06/08/2024

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

Biosimilars/News | Posted 30/07/2024

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.