Amgen/Allergan’s rituximab biosimilar could be $4bn blockbuster

Ten drugs filed with regulators have potential to become billion-sellers by 2025 according to new research, with a near-copy of Roche’s rituximab from Amgen and Allergan showing the most potential.

Data and analytics firm GlobalData said that the rituximab biosimilar, filed with the FDA in December and codenamed ABP 798, is one of several near-copies of the drug that are either on or close to the market.

Branded as Rituxan in the US and MabThera in other markets, rituximab is used in non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL), as well as immunological diseases such as rheumatoid arthritis and various forms of vasculitis.

It is one of Roche’s “big three” cancer drugs and amassed around $7 billion in annual sales at peak, but has been off-patent in the US since 2018.

If approved ABP 798 will follow in the footsteps of Teva/Celltrion’s Truxima and Pfizer’s biosimilar Ruxience, approved by the FDA in 2018 and earlier in 2019, respectively.

A fourth potential rival developed by Novartis subsidiary Sandoz has been cleared in Europe but won’t be developed for the US market after the FDA requested more information on the drug in late 2018.

GlobalData said Amgen and Allergan’s biosimilar could reach almost $4 billion in sales by 2025, far above the predicted sales for other blockbusters in the group, which will all amass $1-$2 billion in annual sales in the next six years.

Other drugs on the list include Bristol-Myers Squibb’s ozanimod (multiple sclerosis), Roche’s risdiplam (spinal muscular atrophy), BioMarin’s valoctocogene roxaparvovec (haemophilia A), Immunomedics’ sacituzumab govitecan (triple negative breast cancer),  and BioHaven’s Zydis (buprenorphine+naloxone) for migraine.

Valentina Gburcik, senior director of cardiovascular and metabolic diseases, gender health and digital at GlobalData, said: “The competitive pricing of the biosimilar drug will help its wider use, and the drug will steal a significant proportion of patient share from the mega-blockbuster Rituxan.”

“The high cost of biologic oncology and haematology therapies coupled with high unmet needs in target patient populations will contribute to the soaring revenues from these drugs.”

 

 

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