Sales of Roche’s Rituxan Have Started to Decline as Biosimilars Thereof are Marketed

Celltrion and Teva Pharmaceutical released big news on October 11, 2018 that the Rituxan® (rituximab) biosimilar: CT-P10 developed by them achieved positive progress: the FDA Advisory Committee voted unanimously 16:0 to recommend approval of marketing of CT-P10, with indications: 1. r/r-CD20+, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent; 2. previously untreated CD20+, B-cell NHL in combination with chemotherapy, as single-agent maintenance therapy; and (3) stable disease, CD20+, B-cell NHL after chemotherapy. After the marketing, CT-P10 will become the first Rituxan® (rituximab) biosimilar approved for marketing in the U.S.

I. Rituxan biosimilar: 2 have been approved for marketing in the EU

There are about 27 Rituxan biosimilars in development in the world, wherein, biosimilars of Teva / Celltrion and Novartis have successively been approved for marketing in the EU. There has been no Rituxan biosimilar marketed in the U.S. See the following table:

Teva / Celltrion filed the marketing application to FDA early in June 2017, which was rejected; they filed the marketing application again in May 2018. Later, there was good news from the FDA Advisory Committee on October 11, 2018 that the committee voted unanimously 16:0 to recommend approval of marketing of the drug that was approved for 3 indications of Rituxan® (rituximab).

CT-P10 will become the first Rituxan® (rituximab) biosimilar approved in the U.S., which will be an important milestone of CT-P10 development. The U.S. market accounts for about 60% market share of Rituxan® (rituximab), and the marketing of this biosimilar will undoubtedly bring more market pressure to sales of Roche’s Rituxan® (rituximab).

II. Sales of Roche’s Rituxan have started to decline as biosimilars thereof are marketed

As a super-blockbuster drug of Roche, Rituxan had sales of nearly USD 7.9 billion in 2017, however, sales of the drug have started to decline as biosimilars are successively marketed.

The biosimilar of Teva / Celltrion started to be sold in the EU in the middle of 2017 at 30-40% discount. I’ve collected market data of Rituxan in the U.S., EU, Japan, and other regions from 2014 to 2018 according to the annual report data of Roche as follows:

Sales in EU have declined significantly:

Sales of Rituxan in EU CHF (one million)

Sales of Roche’s Rituxan in the EU have showed significant decline for two consecutive half years, after biosimilars of Teva / Celltrion and Novartis are successively marketed in the EU.

2018H1 vs 2017H2: -31.55%

2017H2 vs 2017H1: -16.90%

Global sales have started to decline:

Global Sales of Rituxan CHF (one million)

Affected by the European market and marketing of Rituxan biosimilars, global sales of Roche’s Rituxan started to decline for two consecutive half years after peaking in 2017H1.

To face huge market pressure in the U.S. market

The U.S. market accounts for about 61% market share of Roche’s Rituxan. The marketing of the biosimilar of Teva / Celltrion in the U.S. will bring clear market pressure to Roche’s Rituxan.

Market Shares of Rituximab in Main Regions in the World

The era of Rituxan biosimilars will fully arrive as Rituxan biosimilars are successively marketed in the EU, U.S., Japan, and China, etc. The Rituxan (rituximab) biosimilar developed by Henlius, a controlled subsidy of Shanghai Fosun Pharma, will be marketed in 2018 Q4. We look forward to that quality drugs will benefit more patients.

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