An image of a patient with psoriasis. Sandoz’s ustekinumab biosimilar is indication for several autoimmune conditions including psoriasis. Image credit: Shutterstock/Fuss Sergey
Sandoz
has announced the European launch of Pyzchiva, a ustekinumab biosimilar approved for the treatment of several autoimmune conditions including psoriasis and Crohn’s disease.
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Pyzchiva is a biosimilar of Johnson and Johnson Innovation Medicine’s (J&J)
Stelara
, which is approved for treating plaque psoriasis, psoriasis arthritis, and paediatric plaque psoriasis for patients six years and older and weighing over 60kg, as well as Crohn’s disease. In 2021, a Phase III trial (2020-006115-19) demonstrated equivalent efficacy and comparable safety between the biosimilar and reference treatments.
The launch comes after the European Medicines Agency (EMA) approved the therapy in April. Following a US Food and Drug Administration (FDA) approval in June, Sandoz has stated that it intends to launch the biosimilar for the US market in February 2025.
The launch came in the wake of
an agreement
between the Swiss company and Samsung Bioepis, finalised in September 2023. Sandoz holds the commercial rights to Pyzchiva in the US, the EU, the UK, Switzerland, and Canada. Meanwhile Samsung Bioepis retains intellectual property rights and remains responsible for development and supply of the drug. The biosimilar joins the Sandoz’s portfolio of five other biosimilars for autoimmune disorders on the market.
Launching Pyzchiva in Europe holds particular significance. The continent has the highest prevalence of psoriasis worldwide, estimated to affect 6.4 million people, with over 85% of cases presenting as plaque psoriasis. Along with North America, Western Europe is also home to the world’s highest prevalence of Crohn’s disease, creating ample demand for cheaper, more abundantly available therapeutic options.
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According to GlobalData, the market surrounding psoriasis treatments is estimated to have doubled since 2014, potentially reaching $13.1bn globally and $4.13bn in the EU in 2024. While Stelara earned $10.8bn in 2023, the drug sales are estimated to drop to $2.9bn in 2028, as per GlobalData. Pyzchiva is set to benefit from this growing market, with its global sales projected to rise to $120m in 2025 and then further to $339m by 2028.
GlobalData is the parent company of
Pharmaceutical Technology
.
While not the sole ustekinumab biosimilar approved in Europe, Pyzchiva is the first that is available in 90mg or 45mg concentrations for injection and as a 130mg concentration for infusion—the same dose strengths shown to be effective for the reference medicine.
Ustekinumab targets IL-12 and IL-23, both interleukins, which are key to the pathogenesis of several inflammatory diseases. This inhibits signalling and further cytokine production, reducing inflammation and modulating the body’s immune response.
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French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
North Korea
South Korea
Kuwait
Kyrgyzstan
Lao
Latvia
Lebanon
Lesotho
Liberia
Libyan Arab Jamahiriya
Liechtenstein
Lithuania
Luxembourg
Macao
Macedonia, The Former
Yugoslav Republic of
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian Territory
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Réunion
Romania
Russian Federation
Rwanda
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and The South
Sandwich Islands
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
US Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela
Vietnam
British Virgin Islands
US Virgin Islands
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Kosovo
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