Biosimilars
Canada approves first tocilizumab biosimilar Tyenne
On 11 October 2024, Health Canada approved Fresenius Kabi’s tocilizumab biosimilar, Tyenne – the first and only tocilizumab biosimilar currently available in Canada – which references Roche’s Actemra/RoActemra (tocilizumab).
Pertuzumab biosimilar HLX11 meets primary endpoint in Phase 3 comparative clinical study
Shanghai Henlius Biotech and Organon announced on 30 September 2024 that their phase 3 comparative clinical trial for HLX11, an investigational biosimilar to Perjeta (pertuzumab), met its primary endpoint.
Uzpruvo/AVT04 biosimilar in profile
Alvotech and STADA’s Uzpruvo/AVT04 is an ustekinumab biosimilar with similar efficacy, tolerability, safety and physicochemical and biological characteristics to Stelara, the reference product, as has been summarized in a recent study published in Clinical Drug Investigation [1].
EMA recommends approval for ustekinumab biosimilar Absimky and Imuldosa
On 17 October 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 Accord’s Absimky and Imuldosa, both of which are ustekinumab biosimilars referencing Janssen/Johnson & Johnson’s Stelara.
Biologicals and biosimilars available for IBD in Canada
The GI Society (Canadian Society of Intestinal Research) recently published an updated list of originator biologicals and biosimilars used to treat inflammatory bowel disease (IBD), specifically Crohn’s disease and ulcerative colitis, in Canada.
Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
In recent years, biosimilar medicines have gained increased support and access in Australia through the Pharmaceutical Benefits Scheme (PBS), a government program designed to subsidizes essential medicines and make them affordable for all Australians. Biosimilars are versions of original biological medicines that are highly similar in terms of quality, safety, and efficacy but are generally more affordable.
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.
SBR issues consensus on interchangeability of reference products and biosimilars
On 25 September 2024, the Brazilian Society of Rheumatology (SBR, Sociedade Brasileira de Reumatologia) shared its position and consensus on the interchangeability between reference products and biosimilars, a topic of great importance for clinical practice, especially in light of recent regulatory developments by Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária) and other international authorities.
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.
