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| Baxalta CEO Ludwig Hantson |
Partners Baxalta ($BXLT) and Momenta Pharmaceuticals ($MNTA), among the many contenders looking to challenge the world's top-selling drug, posted positive data for their take on AbbVie's ($ABBV) Humira with hopes of launching a competitor in 2018.
The pair's biosimilar, M923, demonstrated itself stable and biologically similar to AbbVie's treatment in a 324-patient study, the companies said. M923 also charted a safety and tolerability profile that fell in line with Humira, according to Baxalta and Momenta.
The two companies are working through a Phase III trial, launched in October, that will finalize whether their take on Humira can stack up to the original. Baxalta and Momenta expect to file the treatment for FDA review in 2017 and launch the product the following year.
AbbVie's therapy, used in a range of autoimmune diseases including rheumatoid arthritis, brought in about $12.5 billion for the company last year, accounting for more than 60% of its revenue. But the patents protecting Humira from biosimilar competition are set to expire at the end of 2016, and a growing number of would-be rivals are queuing up to compete.
Amgen ($AMGN), maker of Humira rival Enbrel, has submitted its biosimilar candidate for FDA approval, leading a group that includes Novartis ($NVS) and Merck ($MRK), which is working with Samsung Bioepis.
The gradual patent expirations for the world's top-selling biologics are expected to create a global biosimilar market worth more than $35 billion by 2020, analysts have said, driven by the loss of exclusivity for Johnson & Johnson's ($JNJ) Remicade, Roche's ($RHHBY) Herceptin and other aging blockbusters.
Baxalta's relationship with Momenta began in 2011 when former parent Baxter ($BAX) signed up to pay $33 million up front and up to $419 million more in a collaboration that covers as many as 6 projects.
- read the statement