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On 16 February 2025, Samsung Bioepis announced that the European Commission has approved Obodence™ (60mg pre-filled syringe) and Xbryk™ (120mg vial), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. The biosimilars are approved for the same indications as the reference medicines. This announcement came just days after the FDA approval of Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb) on 13 February 2025. Obodence™ and Xbryk™ received positive CHMP opinions in November 2024, and are the second set of denosumab biosimilars to be approved in the EU, following Sandoz’s Wyost® and Jubbonti® (approved May 2024). The European Medicines Agency has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024). The CHMP adopted positive opinions for Celltrion’s Osenvelt®/CT-P41 and Stoboclo®/CT-P41 in December 2024. On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis. According to Galderma, Nemluvio® is the first approved mAb specifically targeting IL-31 receptor alpha, inhibiting the signalling of IL-31 (which drives itch and is involved in inflammation and skin barrier dysfunction), and the only approved biologic for atopic dermatitis and prurigo nodularis with 4-week dosing intervals from the start of treatment. Nemluvio® received a positive opinion from the EMA’s CHMP in December 2024. On 14 February 2025, the FDA approved Sanofi-Aventis US’s Merilog™ (injection, 10 mL)/Merilog™ SoloStar (injection, 3 mL) (insulin-aspart-szjj), biosimilars to Novo Nordisk’s Novolog® (insulin aspart), for the improvement of glycaemic control in adults and paediatric patients with diabetes mellitus. Merilog™/Merilog™ SoloStar are the first rapid-acting insulin biosimilars to be approved in the US. There were two long-acting insulin biosimilar products (insulin glargine) approved in 2021, Biocon/Mylan’s Semglee® and Eli Lilly’s Rezvoglar® (reference product: Sanofi’s Lantus®). On 13 February 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its subcutaneous formulation for Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for rheumatoid arthritis (RA). In the same announcement, Celltrion also confirmed that its intravenous (IV) Aptozma™ in 80 mg/4ml formulation received approval. According to Celltrion, this approval completes its Aptozma™ line up in Korea following approval of IV Aptozma™ in 200mg/10ml and 400mg/20ml formulations in December 2024. The December approval marked the first tocilizumab biosimilar approved in Korea. In January 2025, Aptozma™ became the third tocilizumab biosimilar approved in the US, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023). On 13 February 2025, CSL announced that the European Commission has approved Andembry® (garadacimab) to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. This is the third approval for the anti-FXIIa mAb, following January 2025 approvals by Australia’s Therapeutic Goods Administration (TGA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Andembry® was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for funding on Australia’s Pharmaceutical Benefits Scheme (PBS) at its November 2024 meeting. Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug (previously referred to as CSL312) accepted in December 2023. According to CSL, Andembry® is also under review by regulatory agencies in Japan, Switzerland and Canada. On 13 February 2025, the US FDA approved Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb, SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively. The biosimilars are approved for the same indications as the reference medicines. Ospomyv™ and Xbryk™ are the second denosumab biosimilars to be approved in the US, following the approval of Sandoz’s Wyost® and Jubbonti® in March 2024. There are also a number of denosumab biosimilars in the wings, with the FDA having accepted applications for review, including for: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024). In December 2023, Celltrion filed an abbreviated Biologics Licence Application (aBLA) for its denosumab biosimilar, CT-P41. Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown). In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars. That litigation remains pending, as do similar proceedings brought by Amgen against Fresenius Kabi (FKS518/commenced October 2024) and Accord/Intas (INTP23/commenced November 2024). A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances). Amgen also settled its US litigation against Celltrion in January 2025, permitting launch of Celltrion’s yet to be US-approved denosumab biosimilar from 1 June 2025. Samsung Bioepis received a positive opinion from the European Medicine Agency’s CHMP in November 2024 for its denosumab biosimilars (to be marketed as Obodence™ and Xbryk™ in Europe). On 12 February 2025, Qyuns Therapeutics Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorisation application and supplemental application for QX001S, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for use in Crohn’s disease. The NMPA has previously approved QX001S for the treatment of moderate-to-severe plaque psoriasis in adults (October 2024) and for use in paediatric plaque psoriasis (December 2024). Qyuns Therapeutics jointly conducted the R&D and clinical trials for QX001S with Zhongmei Huadong, with QX001S obtaining clinical trial approval in 2018, its Phase I clinical trial completing in 2020, and the Phase III clinical study completing in June 2023. QX001S was the first ustekinumab biosimilar approved in China, followed closely by CSPC Pharmaceutical Group which announced in November 2024 that its biologic licence application for ustekinumab was accepted by the NMPA. On 12 February 2025, Pfizer announced that the US FDA has approved Adcetris® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL). Specific indications include treatment for patients with: The approval is based on data from the Phase 3 ECHELON-3 study, which demonstrated that patients with relapsed/refractory DLBCL who were treated with Adcetris® in combination with lenalidomide and rituximab achieved a statistically significant and clinically meaningful improvement in overall survival. On 12 February 2025, UCB announced that two-year data from the BE HEARD trials for Bimzelx® (bimekizumab) demonstrated sustained disease control in patients with moderate to severe hidradenitis suppurativa (HS). The data revealed that after two years of treatment with bimekizumab, 53.1% of patients achieved mild disease status, compared to 0.0% at baseline. Additionally, 83.4% of patients remained flare-free, and 86.9% of those who responded to treatment at 48 weeks maintained their response. UCB launched its high dose presentation of Bimzelx® in the US in January 2025. Bimzelx® has received several FDA approvals for new indications in recent months, including for moderate to severe HS (November 2024), and for active psoriatic arthritis, active non-radiographic axial spondyloarthritis and active ankylosing spondylitis (September 2024). In May 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider UCB’s application to PBS-list Bimzelx® for moderate to severe HS. On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for patients with recurrent respiratory papillomatosis, ocular conditions, liver cancer and advanced ovarian cancer. Pharmac has also awarded Vegzelma® “principal supply status”, meaning it will be the main funded brand of bevacizumab in the New Zealand public health system until at least 31 August 2028. All patients with recurrent papillomatosis are required to transition to Celltrion’s bevacizumab product by 1 August 2025, but “any brand” of bevacizumab will continue to be funded in public hospitals for patients with ocular conditions. In the same announcement, Pharmac also reported that greater funding will be directed to Roche’s Tecentriq® (atezolizumab) for use in combination with bevacizumab for patients with liver cancer.2025
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
lecanemab | Leqembi® | Eisai/Biogen
liraglutide | Victoza® /Saxenda® | Novo Nordisk
natalizumab | Tysabri® | Biogen/Elan
olaparib | Lynparza® | AstraZeneca/Merck
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
semaglutide | Wegovy®/Ozempic® | Novo Nordisk
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
ustekinumab | Stelara® | Johnson & Johnson/Janssen
BioBlast® Editor and Contributing Author
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