Biosimilars/News
Canada approves pegfilgrastim biosimilar Armlupeg
India-based Lupin Limited (Lupin) announced on 23 August 2024 that it received marketing approval from Health Canada for its biosimilar pegfilgrastim biosimilar, which will be marketed as Armlupeg.
FDA approves fifth ustekinumab biosimilar Imuldosa
On 10 October 2024, the US Food and Drug Administration (FDA) approved Accord’s Imuldosa (ustekinumab-srlf), making it the fifth ustekinumab biosimilar referencing Janssen/Johnson & Johnson’s Stelara.
EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi
The European Commission (EC) granted marketing authorization for three ustekinumab biosimilars: Samsung Bioepis’ Eksunbi on 12 September 2024; Formycon’s Fymskina, and Fresenius Kabi’s Otulfi on 25 September 2024.
FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
The US Food and Drug Administration (FDA) granted approval for two biosimilars, Formycon’s FYB202/Otulfi (ustekinumab-aauz) and Samsung Bioepis’ Soliris biosimilar, Epysqli (eculizumab-aagh), on 27 September and 22 July 2024, respectively. FYB202/Otulfi, a biosimilar referencing Johnson & Johnson’s Stelara, while Epysqli is a biosimilar referencing Alexion’s Soliris.
FDA approves second strength of trastuzumab biosimilar Hercessi
On 18 September 2024, the US Food and Drug Administration (FDA) granted approval for a second strength for Accord’s Hercessi (trastuzumab-strf), a biosimilar referencing Roche’s Herceptin.
EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz
On 19 September 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 two aflibercept biosimilars: Sandoz’s Afqlir and Samsung Bioepis’s Opuviz. These products are biosimilars of the reference product Eylea, developed by Regeneron and Bayer.
FDA approves aflibercept biosimilars Enzeevu and Pavblu
The US Food and Drug Administration (FDA) has approved two more aflibercept biosimilars in August 2024. 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
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
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.
