Mylan and Momenta Pharma Combine Biosimilar Forces

Mylan said today it will partner with Momenta Pharmaceuticals to develop, manufacture, and commercialize six of Momenta’s current biosimilar candidates, including Orencia® (abatacept), in a collaboration that could generate up to $245 million for Momenta, as reported by GEN magazine.

The collaboration is designed to combine Momenta’s biosimilars with Mylan's global R&D, supply chain, and commercial infrastructure. Mylan said the companies will be jointly responsible for product development, with Mylan leading worldwide commercialization efforts.

In a separate statement, Momenta said it will have an option to co-commercialize in a supporting commercial role any approved products in the U.S.

In return, Mylan agreed to pay Momenta $45 million in up-front cash, plus up to $200 million in payments tied to achieving milestones. The companies will share equally in the costs and profits of the biosimilars with respect to the products.

Momenta’s biosimilar pipeline, according to the company’s website, includes nine programs, only two of them disclosed—Orencia (M834) and the company’s lead biosimilar candidate M923, a biosimilar version of Humira® (adalimumab).

Last month, Momenta said M923 met its primary endpoint in a pharmacokinetic study comparing the biosimilar to U.S. and EU Humira reference products in patients with chronic plaque psoriasis. Momenta said it is planning its first regulatory submission for M923 in 2017, and its first commercial launch the following year.

Orencia and the seven unnamed biosimilars are in preclinical phases, with Orencia expected to advance into the clinic this year for moderate to severe rheumatoid arthritis in adults and juvenile rheumatoid arthritis.

Mylan said the partnership with Momenta will complement a biosimilars and insulin analog alliance with Biocon launched in 2009, and will position Mylan as “a definitive world leader” in biosimilars with a portfolio to 15 biosimilar or insulin analog generic products in development.

“This collaboration builds upon Mylan's existing successful biologics and insulins collaboration with Biocon, which is focused on more near-term biosimilar opportunities,” Mylan CEO Heather Bresch said in a statement.

The Biocon partnership includes programs to develop biosimilars for six compounds—trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept, and filgrastim—as well as three insulin analogs—glargine, lispro, and aspart. Mylan said five of those biosimilar programs have successfully completed Phase I clinical trials, while four are in Phase III studies.

Mylan and Biocon expect to submit three biosimilar applications and one insulin application in the U.S. and Europe this year. Mylan already has successfully launched its trastuzumab biosimilar product in India and other emerging markets.