Henlius Collaborates With Getz Pharma for Adalimumab Biosimilar

Shanghai Henlius Biotech has announced a collaboration with Getz Pharma Limited to commercialize an adalimumab biosimilar, Handayuan (HLX03), for several countries throughout Asia and Africa.

The licensing and supply agreement will allow for Getz Pharma to market the product in Pakistan, the Philippines, Vietnam, Cambodia, Myanmar, Nigeria, Kenya, Sri Lanka, Ukraine, Kazakhstan, and Uzbekistan, and any other territories mutually agreed upon.

HLX03 is Henlius’ first self-developed monoclonal antibody in autoimmune treatment. The biosimilar references Humira, which grossed $20.7 billion in sales during 2021, making it the highest grossing drug in the world during 2021 that was not a COVID-19 vaccine. Humira has been approved for more than 10 indications worldwide and is listed as a recommended drug in guidelines for autoimmune disease management in North America and Europe.

In December 2020, HLX03 was approved by China’s National Medical Products Administration (NMPA) for the treatment of rheumatoid arthritis, ankylosing spondylitis, uveitis, and plaque psoriasis. Jiangsu Wanbang oversees commercialization of HLX03 in China.

“In the future, with the long-term commitment to ‘affordable innovation’, Henlius will actively collaborate with more global industry leaders, maximizing the value of biosimilars and accelerating diversified innovation to develop more products based on clinical and market needs to deliver more affordable products to patients worldwide,” said Henius in a compnay statement.

More About Henlius

The company, based in Shanghai, China, had 3 other biosimilar products on the market in China, including Hanlikang (rituximab), Zercepac (trastuzumab), and Hanbetai (bevacizumab). Henlius also has 2 other products in development: HLX04-O, a recombinant anti-vascular endothelial growth factor humanized monoclonal antibody, and Serplulimab, an innovative anti-programmed death-1 monoclonal antibody.

Hanlikang (HLX01) was the first biosimilar to be approved in China. The NMPA approved it in February 2019. The product references Rituxan and is used to treat patietns with non-Hodgkin lymphoma.

Hanbeitai was approved for marketing in China in December 2021 and references Avastin, which is used to treat patients with metastatic colorectal cancer and unresectable locally advanced recurrent or metastatic nonsquamous non–small cell lung cancer. In October 2020, Henlius inked a global development and distribution deal for Hanbeitai with Zhuhai Essex and Essex Bio-Investment for ophthalmic conditions, such as neovascular age-related macular degeneration.

China’s NMPA approved Zercepac (HLX02), which references Herceptin, for marketing in August 2020. It is indicated for treatment of patients with human epidermal growth factor receptor 2-positive breast cancer. Additionally, Zercepac is the first biosimilar developed by Henlius to obtain marketing authorization from the European Commission, which it received in July 2020.

In September 2020, Henlius amended its 2018 license agreement with Accord Healthcare for Zercepac to allow Accord to have the commercialization rights for the biosimilar in the United States and Canada. The original agreement gave Accord exclusive commercialization rights for Zercepac in 53 countries, including the United Kingdom, the European Union, 17 countries in the Middle East and North Africa, and some in the Commonwealth of Independent States.

In June 2020, Helius’ denosumab biosimilar (HLX14) referencing Prolia and Xgeva was approved for marketing in China. Prolia and Xgeva are used to treat conditions that cause bone loss, including postmenopausal osteoporosis. The approval came 2 months after the investigational new drug application for the biosimilar was accepted for review by the NMPA.

Henlius has 3 biosimilars in development, referencing cetuximab (Erbitux), ramucirumab (Cyramza), and pertuzumab (Perjeta). Erbitux is used to treat rectal, head, and neck cancers, Cyramza is used for patients with solid tumors, and Perjeta is a breast cancer treatment.