Oncobiologics, Inc. announced today that Zhejiang Huahai Pharmaceutical Co., Ltd and Oncobiologics have signed an alliance agreement for the development, manufacture and commercialization of biosimilar monoclonal antibody products.  The scope of the agreement includes exclusive commercialization by Huahai of four biosimilars developed by Oncobiologics and manufactured in China at a Huahai biologics facility for the China market, and will also establish a co-development and commercialization partnership for launching such biosimilars to more than 30 developed countries, including the U.S., E.U., Japan, Canada and Australia.  The partnership will seek local partners to drive commercialization in those 30 countries.

The four biosimilars are generic versions of Humira, Rituxan, Avastin, and Herceptin. These biologics are the most popular therapies in the world for their respective cancer and immune-disease indications, representing annual global revenue of more than $40 billion with more than $20 billion in the countries covered by this agreement. The partnership is planning to launch its first product by late 2016.

“This partnership is an important step toward introducing affordable, high-quality biotherapeutics to China.  Huahai is thrilled to partner with Oncobiologics, which brings us excellent biologics development and manufacturing capability, and a deep knowledge of the scientific and quality requirements within the developed world,” said  Vice Chairman of Zhejiang Huahai and CEO of Huahai U.S., Mr. Jun Du.

“Through this partnership, we look forward to establishing a world class biologics operation in China while also participating in the very promising biosimilars market in the developed world.” “Huahai is a leader in small-molecule pharmaceuticals in China, and was the first company in China to receive finished product manufacturing approval from the US FDA.  They are distinguished by commercial strength in China and a deep quality culture in their operations, which is essential as we partner to create a strong biologics capability there,” commented Oncobiologics Founder & CEO Pankaj Mohan, Ph.D.

Mohan added, “Oncobiologics is fortunate to have a strong, experienced partner like Huahai as we work to launch these biosimilar assets to the world’s most important commercial markets.”