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09/01/2021

Hikma, Bio-Thera Solutions partner on potential Stelara biosimilar

Bio-Thera will maintain responsibility for development, manufacturing and supply of the biosimilar Stelara while Hikma will have exclusive rights to commercialize the product in the United States.
Sandra Levy
Senior Editor
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Bio-Thera Solutions and Hikma have entered into a commercialization and license agreement to commercialize BAT2206, a monoclonal antibody that is a proposed biosimilar to Janssen’s Stelara (ustekinumab).

Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206.  Hikma will have exclusive rights to commercialize the product in the United States. The agreement also provides Hikma with a first-right-to-negotiate to add Europe (excluding CIS countries). Bio-Thera is eligible for an upfront payment of $20 million as well as further development and commercial milestones of up to $130 million.

[Read more: Legislation on generics, biosimilars headed for Biden's desk]

“Partnering with Hikma to commercialize BAT2206, our ustekinumab biosimilar, further validates the high quality of the work performed at Bio-Thera,” said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. “We are proud to expand our network of partners to include another great company like Hikma.”

“This partnership provides us with a unique opportunity to enter the biosimilar market in the US, building on our position as a leading generic manufacturer in the US,” said Siggi Olafsson, Hikma CEO. “Tapping into the growth of the biosimilar market in the U.S. has been an area of focus for Hikma. Our established commercial presence in the U.S. market and Bio-Thera’s strong technical capabilities for the development and manufacturing of biological products are highly complementary and we are excited by the potential this partnership offers.” 

Stelara is currently approved for the treatment of active psoriatic arthritis in adults, alone or in combination with MTX, the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn’s disease in adults, and the treatment of moderately to severely active ulcerative colitis in adults.

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