In reporting its second quarter earnings, Momenta Pharmaceuticals stated on August 2 that it no longer plans to market M923, its biosimilar version of Humira®.
“Today, Momenta announced the Company will cease active development of M923 at this time, due to changes in the market opportunity associated with Humira patent litigation settlements,” according to a company press release.
In 2018, Momenta decided to drastically scale back its biosimilar development as part of a strategic review. However, it continues to partner with Mylan on one remaining biosimilar candidate, M710. This is a biosimilar version of aflibercept (Eyela®).
Momenta’s troubles were first apparent after it completed its phase 3 trial of M923 in psoriasis. The clinical study pitted the biosimilar versus the EU-licensed version of adalimumab, and was successfully completed in 2017; however, no FDA filing ensued, despite a company announcement that it would occur in 2018. Later that year, the company stated that it delayed filing for financial reasons, but it would continue to seek a partner to commercialize the product.
In 2018, it signed a licensing agreement with AbbVie, which would have allowed it to launch in December 2023—in the back of the pack of licensed biosimilars in terms of timing (which could not have helped its efforts to seek a partner). In view of its refocusing its strategic outlook, the delay in filing a 351(k) biologic licensing application (BLA) application with the FDA may have made some sense from a couple of perspectives
First, the company may have thought twice about continuing expenditures if it was undecided as to whether it would remain committed to the biosimilar development. These expenditures could be quite significant (beyond payment of user fees) if the FDA requested additional data in an initial review of the BLA.
Second, with a potential launch date of December 2023, Momenta certainly had time to get its ducks in a row. If a commercialization partner could be lined up before the BLA filing, that company could help shoulder additional associated costs.
In any case, Momenta’s pull back is not entirely unexpected. Though it intended to file an application with the European Medicines Agency early this year (which would not have required a further delay in launch), this also did not occur (probably because of existing biosimilar adalimumab competition in Europe).