More woe for Roche as another Rituxan biosimilar approved in US

Roche Rituxan approval

The FDA has approved a second biosimilar of Roche’s leukaemia drug Rituxan, along with yet another biosimilar of AbbVie’s inflammatory diseases blockbuster Humira.

The regulator has approved Pfizer’s Ruxience, the second biosimilar to Roche’s Rituxan (rituximab), for adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Celltrion and Teva’s Truxima became the first rituximab biosimilar to get approval last November, and is to launch imminently on an undisclosed date following an agreement with Roche.

There was no word from Pfizer about launch date either, as in the US originator companies have often constructed “thickets” of patents that can stave off cheaper competitors for considerable periods of time.

Pfizer also left out any details about pricing from its announcement, but in the US biosimilars are sold at a considerable discount to originator drugs but not at the rock-bottom prices associated with generics.

Amgen and Allergan biosimilars to Roche’s other big cancer drugs Avastin and Herceptin launched earlier this week in the US at average selling price discounts of 12% and 13%, respectively.

In the US alone annual sales of Rituxan are in the region of $4.3 billion and the drug has already seen sales fall dramatically in Europe thanks to biosimilar competition.

Herceptin and Avastin generated sales of $5.8 billion in the US in 2018, and for years have formed the backbone of Roche’s drugs business.

In a separate development the FDA has also approved Merck & Co’s biosimilar to AbbVie’s blockbuster inflammatory diseases and arthritis treatment Humira (adalimumab).

Merck & Co’s biosimilar will be branded as Hadlima and was developed and manufactured by Samsung Bioepis, a South Korean joint venture between Samsung and Biogen, with the US pharma holding marketing rights.

With sales last year of nearly $20 billion Humira is the world’s biggest-selling drug by revenue, but has gone off-patent in Europe, where biosimilars are already beginning to take market share.

However in the US AbbVie has watertight legal defences in place until the start of 2023, when a gang of biosimilars are due to hit the market.

It looks like this will also apply to Hadlima, which must carry a boxed warning like the originator citing issues including increased risk of serious infections such as tuberculosis and bacterial sepsis.

Biosimilars are near-copies of biologic drugs that have been proven to be as safe and effective as the original drug.

However because they are manufactured in cells rather than the lab there can be slight differences compared with the original branded medicine.