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May 8, 2013

Oncobiologics Finds Partner to Launch Biosimilars in U.S., China

  • Zhejiang Huahai Pharmaceutical will develop, manufacture, and commercialize for the Chinese market four biosimilars being developed by U.S.-based Oncobiologics, as part of a partnership the companies disclosed today.

    Under the partnership, the companies also agreed to establish a co-development and commercialization partnership for launching the biosimilars in more than 30 developed countries, including the U.S., the EU, Japan, Canada, and Australia. That effort will include local partners, Zhejiang Huahai and Oncobiologics said.

    The companies said they will commercialize generic versions of Humira®, Rituxan®, Avastin®, and Herceptin®, with the first product set to be launched by late 2016. The nations covered by the partnership account for more than half of the more than $40 billion in combined annual sales the drugs collectively enjoyed last year.

    Financial terms were not disclosed.

    "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," Jun Du, vice chairman and CEO of Zhejiang Huahai U.S., said in a statement. "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."

    Fouded in 1989, Zhejiang Huahai produces finished dosage forms, APIs (active pharmaceutical ingredients), and intermediates for both domestic and international markets. The company has a staff of 3,800, and 11 subsidiaries in the U.S. and the Chinese cities of Shanghai, Hangzhou, and Linhai.

    Oncobiologics, which started in May 2011, is developing biosimilars and new biotherapeutics focused on cancer, immuno-oncology, and immunology. The company’s original drugs are based on its Trident™ discovery platform, which integrates fully human, single-chain, bi-specific antibodies with HSA binding.

    Pankaj Mohan, Ph.D., Oncobiologics’ founder & CEO, noted in the statement that Zhejiang Huahai was the first Chinese company to receive finished product manufacturing approval from the 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.”

    The deal with Zhejiang Huahai is the second biosimilar collaboration inked by Oncobiologics this year. On February 25, the company gave Viropro rights to manufacture six Oncobiologics-developed monoclonal antibody products for commercialization in more than 70 emerging market countries (excluding China). In addition to the four biosimilars announced for China, the Viropro deal included a biosimilar to Erbitux® and an undisclosed biotherapeutic.

    Viropro also won exclusive commercialization rights to the six biosimilars for Malaysia, while the companies agreed to co-manage Viropro’s Penang, Malaysia, Alpha Biologics biomanufacturing subsidiary.


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