Biosimilars
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.
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.
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 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.
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.
Innovative direct purchase agreement sees adalimumab biosimilar prices slashed
On 1 October 2024, Blue Shield of California in the US announced that it will pay far less for an adalimumab biosimilar. The transparent net price paid by the health plan provider will be US$525 per monthly dose, compared to the market-reported net price of reference product Humira at US$2,100.
