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The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.
Editor's Note: This article was published in Pharmaceutical Technology Europe's February 2019 print issue.
In the European Union (EU), the landscape for biosimilar medicines continues to be robust, with 16 products representing six biosimilar molecules granted marketing authorization by the European Commission (EC) in 2018. This number is consistent with the biosimilar marketing authorizations granted by the EC in 2017 (1).
Dominating the marketing authorizations was Novartis’ Sandoz, which garnered five biosimilar product approvals, or 31% of total approvals. Pharma major Mylan followed close behind with four biosimilar product approvals, or 25% of total approvals. Amgen also won multiple marketing approvals, and Pfizer received one. Other companies that received marketing authorization for biosimilars include Accord Healthcare Limited, Celltron, Cinfa Biotech, and ERA Consulting (see Table I).
Between Sandoz, Mylan, Amgen, and Pfizer, pharma majors accounted for 75%, or 12, of total 2018 EU marketing approvals for biosimilar products. The six biosimilar molecules these products represent are adalimumab, bevacizumab, infliximab, insulin glargine, pegfilgrastim, and trastuzumab.
Sandoz’s five marketing approvals include Zessly (infliximab), Ziextenzo (pegfilgrastim), and three adalimumab biosimilars: Halimatoz, Hefiya, and Hyrimoz. Zessly is a biosimilar referencing Remicade (infliximab), Johnson & Johnson’s top-selling drug with US$5.3 billion (€4.6 billion) in 2018 sales (2). In the EU, Zessly is indicated for treating rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriasis, and psoriatic arthritis.
Sandoz’s three biosimilar adalimumab products-Halimatoz, Hefiya, and Hyrimoz-reference AbbVie’s Humira (adalimumab), which is AbbVie’s top-selling drug with nearly US$20 billion (€17 billion) in 2018 sales (3). Hefiya is indicated for plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, acne, and uveitis; Halimatoz is indicated for the same conditions plus active enthesitis-related arthritis, and ulcerative colitis; and Hyrimoz is indicated for all the same conditions as Halimatoz as well as Crohn’s disease.
Ziextenzo, indicated for treating neutropenia, is a biosimilar referencing Amgen’s Neulasta (pegfilgrastim), also a blockbuster drug with approximately US$4.5 billion (€3.9 billion) sales in 2018 (4).
Similarly endowed, Mylan also received marketing approvals for biosimilars referencing blockbuster innovator biologics. Mylan’s approvals include Semglee (insulin glargine), Hulio (adalimumab), Fulphila (pegfilgrastim), and Ogivri (trastuzumab). Semglee references Sanofi’s Lantus, which earned €2.7 billion (US$3.1 billion) in the first nine months of 2018 (full-year 2018 sales data not available at time of this article’s publication) (5). Ogivri references Roche’s Herceptin, which garnered CHF 5.3 billion (€4.6 billion, US$5.3 billion) in the first nine months of 2018 (full-year 2018 sales data not available at time of this article’s publication) (6). It is indicated for breast and stomach cancer.
As with Sandoz’s biosimilars, Mylan’s Hulio references AbbVie’s Humira and is indicated for treating plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, Crohn’s disease, ulcerative colitis, acne, and uveitis. Mylan’s Fulphila references Amgen’s Neulasta and is indicated for neutropenia.
With two biosimilar marketing approvals in 2018, Amgen’s products include Mvasi (bevacizumab) and Kanjinti (trastuzumab). Mvasi references Roches’ Avastin (bevacizumab), another blockbuster biologic with CHF 5.1 billion (€4.4 billion, US$5.1 billion) in the first nine months of 2018 (6). Mvasi is indicated for treating colon, breast, lung, kidney, ovarian, and cervical cancer. Kanjinti is another biosimilar referencing Roche’s Herceptin and is indicated for breast and stomach cancer.
Also stepping up competition in oncology is Pfizer’s Trazimera (trastuzumab), another biosimilar referencing Herceptin. Pfizer’s product is also indicated for treating breast and stomach cancer.
The other companies accounting for the rest of the biosimilar marketing approvals in the EU last year were Accord, an India-based global supplier of generic and speciality pharmaceuticals, Celltron, a South Korea-based biopharmaceutical company, Cinfa Biotech, a Spain-based biopharmaceutical company specializing in biosimilars, and ERA Consulting, a German-based consulting firm that specializes in product development and regulatory affairs.
Accord, Cinfa Biotech, and ERA Consulting all received EU approval for their respective pegfilgrastim biosimilars, referencing Neulasta. Accord’s product is Pelgraz; Cinfa Biotech’s product is Pelmeg; and ERA Consulting’s product is Udenyca. All are indicated for treating neutropenia. Celltrion received approval for Herzuma (trastuzumab), also referencing Herceptin and indicated for breast and stomach cancer.
1. EMA, www.ema.europa.eu/en/search/search?sort=field_ema_med_market_auth_date&order=desc&search_api_views_fulltext=biosimilar, accessed 23 Jan. 2019.
2. Johnson & Johnson, “Johnson & Johnson Reports 2018 Fourth-Quarter Results,” Press Release, 22 Jan. 2019.
3. AbbVie, “AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results,” Press Release, 25 Jan. 2019.
4. Amgen, “Amgen Reports Fourth Quarter And Full Year 2018 Financial Results,” Press Release, 29 Jan. 2019.
5. Sanofi, “Sanofi Q3 2018 Performance Confirms Return to Growth,” Press Release, 31 Oct. 2018.
6. Roche, “Roche Reports Very Strong Growth in the First Nine Months of 2018,” Press Release, 17 Oct. 2018.
Pharmaceutical Technology Europe
Vol. 31, No. 2
When referring to this article, please cite it as F. Mirasol, “Roundup of European Biosimilars Approved in 2018," Pharmaceutical Technology Europe31 (2) 2019.