Roche MS drug sales rise, but so does biosimilar threat

Impressive sales for Roche’s latest multiple sclerosis drug have for now offset the impact of biosimilar competition to its blockbuster MabThera/Rituxan (rituximab).

But after a mixed set of third quarter results, analysts are predicting the Swiss firm is facing a difficult few years as its three best-selling blockbuster drugs face biosimilar competition for the first time.

Roche’s sales rose 6% to $13.1 billion Swiss francs ($13.4 billion) after MS drug Ocrevus mitigated the impact of rituximab biosimilars in Europe.

Ocrevus’ sales were 308 million Swiss francs after launching earlier this year, but sales of rituximab were almost flat at 1.78 billion francs, dented by European revenues that were down 16%.

Rituximab is off-patent in Europe, where Sandoz and Celltrion have biosimilars approved across its indications in oncology such as non-Hodgkin lymphoma and chronic lymphocytic leukaemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Rituxan, along with cancer drugs Herceptin (trastuzumab) and Avastin (bevacizumab) generate annual sales in excess of $21 billion – more than half of Roche’ drug business.

All face biosimilar competition – while Biocon/Mylan’s Herceptin biosimilar is delayed because of manufacturing issues, Samsung Bioepis filed its Herceptin copycat with European regulators around a year ago, meaning a decision is likely soon.

Herceptin is off-patent in Europe and is also under threat in the US, where Celltrion has challenged its patent and has a biosimilar under review with the FDA along with Amgen and Allergan.

Sales of Herceptin in Q3 were flat compared with last year at 1.69 billion francs, while Avastin revenue fell 4% to 1.59 billion francs.

But analyst forecasts compiled by Thomson Reuters predict sales of the three drugs will fall more than 40% by 2022.

Roche still expects sales to grow around the mid-single digit rate for 2017, driven by newer drugs such as cancer immunotherapy, Tecentriq (atezolizumab).


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