Celltrion and Teva Snag Second Biosimilar Approval of a Genentech Drug

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The U.S. Food and Drug Administration (FDA) approved another biosimilar. On Friday, the regulatory agency approved Herzuma, a biosimilar to Genentech’s Herceptin developed by South Korea-based Celltrion and Israel-based Teva Pharmaceutical.

Herzuma is a HER2/neu receptor antagonist biosimilar for the adjuvative treatment of HER2 overexpressing node positive or node negative breast cancer, as well as part of a first-line treatment for metastatic breast cancer combined with chemotherapy.

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For Celltrion, the approval of Herzuma marked its second biosimilar approved in the United States in the past few weeks. At the end of November, the FDA approved Truxima, a biosimilar to Genentech’s Rituxan, a treatment for non-Hodgkin’s Lymphoma. Like Herzuma, Truxima was co-developed with Teva.

Woosung Kee, Celltrion’s chief executive officer, said that biosimilars are of growing importance in oncology treatment. With the approval of Herzuma, Kee said it reinforces the goal of all his company’s approved products, which is “providing broader treatment options for patients and the providers who treat them.”

Teva’s head of commercial operations in North America, Brendan O’Grady, also touted the FDA approval as a product that will help the company “leverage” its strengths in oncology and generics.

The Celltrion and Teva breast cancer drug does come with a boxed warning. The safety warning notes that treatment with Herzuma could be associated with cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.

Last month Celltrion shared its vision on how access to biosimilar drugs will help shape the future of healthcare. During the annual biosimilars conference in New Jersey, Celltrion said that biosimilars, which are which are exact replicas of other drugs, provide a “greater treatment choice and value, better access to treatments and improved patient outcomes.” Citing IMS Health, Celltrion said the use of biosimilars could lead to savings of $107 billion by 2020.

As Celltrion and Teva celebrate another FDA approval of a biosimilar drug, Australia-based NeuClone Pharmaceuticals Ltd. announced that it is developing its sixth biosimilar product. The company said this morning that it has a preclinical asset that is a biosimilar of Genentech’s Perjeta (pertuzumab), a treatment for HER2+ breast cancer. In addition to the pertuzumab biosimilar, NeuClone is also developing a biosimilar of Herceptin (trastuzumab), which is currently in clinical development.

NeuClone is partnering with Serum Institute of India for the development of its biosimilar products. The two companies plan to develop 10 biosimilar products.

Like Celltrion’s Kee, Noelle Sunstrom, NeuClone’s CEO, touted the importance of biosimilars as a healthcare option. Current combination treatments of monoclonal antibodies are typically clinically superior to monotherapies, she said, but are also more expensive.

“We are determined to dramatically expand the number of patients able to receive these life-changing combination therapies by offering lower-priced biosimilars of both mAbs,” Sunstrom said.

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