EMA Recommends Four Biosimilars for Approval

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The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has offered a positive opinion on four biosimilars, recommending the granting of marketing authorization for these products, the agency announced in a June 1, 2018 statement summarizing the results of its recent committee meeting in late May 2018.

The four biosimilars that received the CHMP’s recommendation are three adalimumab biosimilars from Novartis and a trastuzumab biosimilar from Pfizer. The adalimumab biosimilars reference AbbVie’s Humira (adalimumab), which is that company’s top-selling product with 2017 sales of more than $18 billion. The trastuzumab biosimilar references Roche’s Herceptin (trastuzumab), which is one of Roche’s top-selling products with 2017 sales of CHF $7 billion(US$7.1 billion).

The CHMP recommended approval of Novartis’ Halimatoz, Hefiya, and Hyrimoz-all containing adalimumab-for treating certain inflammatory and autoimmune disorders and Pfizer’s Trazimera (trastuzumab) for treating breast and gastric cancer.

Novartis, through its generic drug arm, Sandoz, is seeking approval of the proposed biosimilar adalimumab products for use in all reference medicine indications, including rheumatology, gastroenterology, and dermatology. The committee’s positive opinion recommends granting marketing authorization for indications including rheumatoid arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis.


Pfizer is seeking approval for its trastuzumab biosimilar for treating HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

“Many patients with breast and gastric cancers have an HER2 overexpression, which can correlate with poor outcomes and aggressive disease,” said Dr. Mark Pegram, associate director for clinical research at the Stanford Comprehensive Cancer Institute, and director of the breast oncology program at the Stanford Women’s Cancer Center, in a company press release issued by Pfizer. “With the availability of biosimilars like Trazimera in Europe, oncologists will have additional treatment options to choose from, which potentially helps our patients have greater access to these medicines.”

Source: EMA, Novartis, Pfizer