European Commission authorises one of first ustekinumab biosimilars in Europe

Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva^® (biosimilar ustekinumab).

Pyzchiva was developed and registered by Samsung Bioepis to match the reference medicine. It is approved for autoimmune disorders within disease areas such as gastroenterology and dermatology.

“This approval is a crucial step towards offering European patients an additional safe and effective treatment option and further demonstrates our commitment to pioneer access to potentially life-changing medicines,” Rebecca Guntern, President Sandoz Europe commented.

According to Sandoz, the regulatory submission package for Pyzchiva included “extensive analytical, preclinical, and clinical data, including a Phase I PK/PD study and a Phase III confirmatory study”.

Progressing Pyzchiva

Sandoz entered into a development and commercialisation agreement for the biosimilar ustekinumab with Samsung Bioepis in September 2023.

Under terms of the deal, Sandoz was given commercialisation rights for Pyzchiva in the US, Canada, the European Economic Area (EEA), Switzerland, and the UK. Samsung Bioepis is responsible for development, registration, intellectual property (IP), manufacturing and supply.

Recent biosimilar developments

In February 2024, the EMA’s Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for Pyzchiva as a biosimilar to treat the autoimmune condition plaque psoriasis.

Another of Sandoz’s recent developments, announced last month, was authorisation of the first and only US Food and Drug Administration (FDA)-approved denosumab biosimilars, to treat all indications of the reference medicines. The company’s Wyost^® (denosumab-bbdz) and Jubbonti^® (denosumab-bbdz) were deemed interchangeable for all indications of Xgeva^® (denosumab) and Prolia^® (denosumab).

A report on the biosimilars market has highlighted that because these medicines provide a cost-effective alternative to the reference product, the market has grown rapidly over the past few years. Looking ahead to the future, the report predicted that demand for affordable biologic drugs is expected to increase and will therefore generate a larger biosimilars market.