Despite Overall Increases, Blockbuster Roche Products Take Hit From Biosimilars

Roche’s earnings report for the first quarter (Q1) of 2022 revealed significant decreases in revenue thanks to increased biosimilar competition in the trastuzumab, bevacizumab, and rituximab markets.

Although the company saw an overall 6% increase in pharmaceutical division sales, the introduction of biosimilars referencing Herceptin (trastuzumab), Avastin (bevacizumab), and Rituxan (rituximab) led to sales decreases between 19% and 32% for the 3 reference products compared with their performance during Q1 2021.

Currently, the FDA has approved 3 bevacizumab biosimilars, 3 rituximab biosimilars, and 5 trastuzumab biosimilars, all of which have launched on the US market with the exception of Alymsys (bevacizumab-maly). Alymsys, a biosimilar developed by Amneal Pharmaceuticals, was approved in late-April 2022.

Additionally, patients throughout the European Union have access to 7 bevacizumab biosimilars, 5 rituximab biosimilars, and 6 trastuzumab biosimilars. Herceptin, Avastin, and Rituxan are all used to treat different types of cancers.

Roche Earnings and Losses

In the United States, Roche’s sales increased by 2%, largely driven by sales for Ocrevus (ocrelizumab), Hemlibra (emicizumab-kxwh), Actemra (RoActemra; tocilizumab), Tecentriq (atezolizumab), and Phesgo (pertuzumab/trastuzumab/hyaluronidase). Sales across North America (up 59%), Asia and the Pacific Islands (up 34%), Latin American (plus 9%), and the Middle East and Africa (up 2%) increased.

Japan had the greatest increase in sales, up 69%, which Roche attributed to the high demand for Ronapreve (casirivimab/imdevimab), Polivy (polatuzumab vedotin), and Evrysdi (risdiplam) in the country.

However, sales decreased by 1% in Europe, with the growth observed for certain medications being offset by biosimilar sales. Biosimilar competition also caused a 9% sales decline in China. Further, the sales growth of Perjeta (pertuzumab), Ronapreve, Alecensa (alectinib), Evrysdi, Hemlibra, and Ocrevus were neutralized due to biosimilar competition.

Combined, the global sales for Herceptin, Avastin, and Rituxan was reduced by CHF 568 million ($591 million) for Q1 2022 vs Q1 2021. Roche claimed that the impact of biosimilar competition for these medications has slowed down, which was in line with the company’s expectations.

The reference product that took the biggest hit due to biosimilars was Avastin, which achieved CHF 581 million ($603 million), a 32% decline from Avastin sales during Q1 2021. Bevacizumab products are indicated for the treatment of colorectal, lung, glioblastoma, kidney, cervical, and ovarian cancers and is sometimes used off-label for the treatment of neovascular age-related macular degeneration (wet AMD).

During Q1 2022, Herceptin accumulated CHF 607 million ($631 million), a 19% decline in sales from what it generated during Q2 2021. Trastuzumab products are indicated for human epidermal growth factor receptor 2-positive breast, stomach, and esophageal cancers.

Rituxan experienced a 21% sales decline, generating CHF 564 million ($586 million). Rituxan, also known as MabThera, and its biosimilars are used for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia as well as some autoimmune conditions, including rheumatoid arthritis, granulomatosis with polyangiitis and microscoping polyangiitis, and pemphigus vulgaris.

Interestingly, the US sales for Lucentis (ranibizumab) were down 26% from those during Q1 2021, accumulating CHF 256 million ($266 million). Although Lucentis faces no biosimilar competition in the US currently, 1 biosimilar (Byooviz) has been approved by the European Medicines Agency, the FDA, and Health Canada. Roche did not specify the reason for the decline in sales.

Byooviz is expected to enter the US market around June 2022. Lucentis is used to treat ophthalmic conditions including wet AMD, diabetic retinopathy, and diabetic macular edema.