Biosimilars
Stelara biosimilars enter US market with 85% discount in 2025
In February 2025, Teva Pharmaceuticals and Alvotech announced the availability of Selardsi (ustekinumab-aekn) in the US, followed by Sandoz’s Pyzchiva (ustekinumab-ttwe). These two products are biosimilars to the originator drug, Johnson & Johnson’s Stelara (ustekinumab).
Canada approves pegfilgrastim biosimilar Pexegra
On 25 February 2025, Health Canada granted marketing authorization to India-based Kashiv BioSciences for its pegfilgrastim biosimilar, Pexegra, which references Amgen’s Neulasta (pegfilgrastim).
IFPMA publishes position on pharmacy-mediated substitution for biosimilars
In January 2025, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published a position paper, ‘Pharmacy-mediated substitution for biosimilars’.
Optimizing costs with biosimilars: Brazil's case
The adoption of biosimilars, biological drugs similar to reference medications, has emerged as a pivotal strategy for reducing healthcare costs while maintaining efficacy and safety. A review by Azevedo, VF, et al.examines how Unimed Maringá, a private healthcare provider in Brazil, implemented a biosimilar management programme, achieving significant cost savings and broader patient access to essential therapies [1].
Insulin aspart and denosumab biosimilars approved in US
In February 2025, the US Food and Drug Administration (FDA) approved Sanofi-Aventis’ Merilog (insulin aspart-szjj), referencing NovoNordisk’s NovoLog (insulin aspart); and Samsung Bioepis’ Ospomyv and Xbryk (denosumab-dssb), referencing Amgen’s Prolia and Xgeva, respectively. Additionally, the FDA granted a provisional determination of interchangeability designation for both Ospomyv and Xbryk with its reference medicines.
The ustekinumab shift: biosimilars displace Stelara’s market leadership
The ustekinumab market is heating up as biosimilar developers aggressively challenge the dominance of Stelara, Johnson & Johnson’s blockbuster drug for autoimmune diseases. With eight biosimilars approved in Europe and seven in the US, the competition is fierce, and the stakes are high.
Biosimilars in low- and middle-income countries
Biosimilars offer a viable route to treatment for those with non-communicable diseases (NCDs) living in low- and middle-income countries (LMICs). A review article published in GaBI Journal titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries,’ offers insights into the benefits of biosimilars for better access to biologics in LMICs, focusing on data from selected emerging markets (Brazil, Colombia, Malaysia, Mexico, Nigeria, Taiwan, and Turkey).
FDA approves tocilizumab biosimilar Avtozma
On 24 January 2025, the US Food and Drug Administration (FDA) has approved tocilizumab biosimilar, Avtozma (tocilizumab-anoh). Celltrion’s Avtozma (tocilizumab-anoh)/CT-P47 is a biosimilar referencing Roche/Genentech’s Actemra/RoActemra (tocilizumab).
Brazilian law establishes December 16 as National Biosimilar Day
On 6 January 2025, President Luiz Inácio Lula da Silva sanctioned Law 15.087/25, officially declaring December 16 as National Biosimilar Drug Day in Brazil. The law, published in the Official Gazette of the Union, aims to raise awareness about the importance of biosimilars in the healthcare system.
January 2025 biosimilar approvals in Europe
On 30 January 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for for three biosimilar medicines: Dyrupeg (pegfilgrastim), Pavblu (aflibercept) and its duplicate Skojoy (aflibercept).
