Shire has terminated a five-year-old collaboration with Momenta Pharmaceuticals to develop and commercialize a proposed biosimilar of Humira (adalimumab).

Momenta said in a statement Shire terminated the partnership “based on a comprehensive portfolio assessment” following Shire’s completion in June of its $32 billion merger with Baxalta.

Under the 2011 agreement signed by Momenta with Baxter International—from which Baxalta was spun out last year—the collaboration will end in 12 months, with Shire obligated to fund the “M923” biosimilar Humira program until termination.

In the meantime, Momenta added, Shire will begin to transfer all ongoing clinical, regulatory, and commercialization activities.

“We view Shire's decision as a significant opportunity for us to capture additional value from this program for the Company and its shareholders,” Momenta president and CEO Craig Wheeler said in a statement. “We remain very excited about the potential for our biosimilar Humira candidate.”

By year’s end, Wheeler added, Momenta will report top-line results of the current Phase III trial of M923. The study is designed to compare the safety, efficacy, and immunogenicity of M923 with Humira in patients with chronic plaque psoriasis.

Humira is indicated for numerous autoimmune/inflammatory disorders, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis.

Momenta’s biosimilar Humira will face competition. On Friday, the FDA approved Amgen’s biosimilar version of the drug, Amjevita (adalimumab-atto). The European Medicines Agency in July accepted for review Samsung Bioepis’ biosimilar version SB5, to be marketed by Biogen. Earlier this year, Merck Group launched Phase III trials for its biosimilar Humira. And in India, Cadila Healthcare has marketed its own biosimilar Humira since December 2014.

In a regulatory filing, Momenta stated that it had received $52 million from Baxalta and Baxter through the collaboration agreement—a $33 million upfront payment, a $7 million license payment for achieving pre-defined “minimum development criteria” for M834, Momenta’s biosimilar Orencia ® (abatacept) candidate, and $12 million in technical and development milestone payments in connection with the UK Medicines and Healthcare Products Regulatory Agency’s acceptance of Baxalta’s clinical trial application to initiate a pharmacokinetic clinical trial for M923.

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