FDA review extension will affect launch of Novartis’ ofatumumab, says GlobalData

Following the review extension from the Food and Drug Administration (FDA) of anti-CD20 monoclonal antibody drugs for multiple sclerosis (MS) to September 2020, which will affect the launch of Novartis’ ofatumumab;

Alessio Brunello, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“Ofatumumab is expected to enter the US MS market in 2021, and the 5EU and Japan markets in 2022. As a second-in-class anti-CD20 disease modifying therapy (DMT), Novartis will need to demonstrate a clinical advantage for ofatumumab in order to differentiate it from Roche’s Ocrevus, which will hold an established position in the market.

“The main advantage of ofatumumab is that it is administered by subcutaneous injection. There is no infusion cost or inconvenience to the patients or payers. However, physician do not have any experience using this medication yet and will most likely prefer Roche’s Ocrevus more due to the experience they have with this drug as it was approved in 2017 in US.

“GlobalData forecasted global sales of ofatumumab to be equating to $3.3bn in 2028 in the seven major markets (*7MM) and to be the top selling pipeline asset in MS. Its sales are likely to further increase beyond 2028, as the drug will remain in a growth phase while global sales of Roche’s Ocrevus are expected to reach $7.6bn in 2028 in the 7MM, due to notable clinical attributes of the drug that will support strong market uptake, including high efficacy that appears to be comparable to its competitor Biogen’s Tysabri, as well as infrequent dosing and no reported cases of Progressive multifocal leukoencephalopathy (PML) during clinical trials.

“Key opinion leaders (KOLs) interviewed by GlobalData explained that ofatumumab’s subcutaneous (SC) formulation would be helpful for patients who have to travel long distances for infusions. Despite this, ofatumumab will struggle to compete with Ocrevus, as the Roche/Genentech product will be established in the treatment algorithm at the time of ofatumumab’s launch. However, ofatumumab is also likely to launch in Japan, given there is an ongoing clinical trial of ofatumumab in Japanese patients while Ocrevus not expect Ocrevus to launch in Japan, as there are currently no clinical trials involving Japanese patient populations planned.”

*7MM: US, France, Germany, Italy, Spain, UK and Japan

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