The US Food and Drug Administration (FDA) has approved Samsung Bioepis’ Pyzchiva (ustekinumab-ttwe), a biosimilar referencing Johnson & Johnson’s Stelara.
Pychiva, which will be commercialised in the US by Sandoz, is now authorised to treat adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately-to-severely active Crohn’s disease and moderately-to-severely active ulcerative colitis, as well as paediatric patients with moderate-to-severe plaque psoriasis and active psoriatic arthritis.
A provisional determination has also been granted for Pyzchiva’s interchangeability.
Biosimilars, according to the FDA, are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved product. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.
The regulator’s decision on Pyzchiva was supported by a totality of evidence demonstrating that the drug has equivalent efficacy and comparable safety to its reference medicine.
Byoung In Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said: “The FDA approval of Pyzchiva as a biosimilar to Stelara is an important milestone for patients living with inflammatory conditions, as biosimilars can offer more choice and access to biologic treatments.”
Samsung Bioepis and Sandoz entered into a commercialisation agreement for Pyzchiva last year for the US, UK, European Economic Area, Switzerland and Canada.
Sandoz’s chief scientific officer, Claire D’Abreu-Hayling, said: “By further expanding our immunology portfolio with affordable biosimilar alternatives, we continue to make significant strides towards… delivering life-changing medicines to the patients who need them.”
The decision comes just a few months after Sandoz received approval from the FDA for the first biosimilars of Amgen’s bone disease therapy, denosumab.
Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) were authorised as interchangeable biosimilars for all indications covered by Amgen’s reference medicines Xgeva (denosumab) and Prolia (denosumab), respectively.
Wyost was approved to treat bone complications from cancer, including bone metastases associated with solid tumours and multiple myeloma, while Jubbonti has been approved for the treatment of osteoporosis in certain patient populations.
The European Commission has since granted marketing authorisation to Wyost and Jubbonti.