October 16, 2018

October 16, 2018

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October 15, 2018

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FDA Approves Third Biosimilar Product

As we predicted in yesterday’s post, FDA approved a new biosimilar product, Sandoz’s Erelzi (etanercept-szzs), which is a biosimilar to Amgen’s Enbrel (etanercept), on August 30th. FDA’s decision comes shortly after its Arthritis Advisory Committee voted unanimously in support of approving the biosimilar. FDA followed its draft naming guidance and assigned the biosimilar’s non-proprietary name using the reference product’s drug substance name followed by a nonsense four-letter suffix. Erelzi becomes the third biosimilar to receive FDA approval (the second for Novartis subsidiary Sandoz) and is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis, similar to Enbrel.  However, Erelzi cannot be launched commercially until at least 6 months after Sandoz provides Amgen with the mandatory notice required under the law, which the Federal Circuit Court of Appeals has affirmed cannot be provided until after FDA approves the biosimilar application.

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Joanna Hawana, Mintz Levin, FDA Lawyer, Consumer Protection Attorney, Washington
Of Counsel

Joanne advises clients around the world in the food, drug, and biotechnology industries on issues ranging from prescription drug advertising to state licensing requirements for wholesale distribution. In particular, Joanne counsels clients on the business impact of new US federal and state actions that affect regulated products, such as drugs, foods, and medical devices.

Joanne is experienced in US federal drug regulations, including pre-market and post-market requirements, and restrictions on advertising and sampling. Joanne also has counseled...

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Sarah Beth S. Kuyers, Mintz Levin, nonprofit affiliation lawyer, health care systems attorney
Associate

Sarah Beth’s practice focuses on advising health care providers, PBMs, and laboratories on a variety of regulatory issues.

Prior to joining Mintz Levin, Sarah Beth worked as a law clerk with the health staff of the US Senate Committee on Finance, where she researched policy, regulations, and legislation regarding commercial insurance reform, health IT, Medicare, Medicaid, and the Affordable Care Act. She also drafted legislation.

In addition, Sarah Beth worked as a law clerk for a legal practice in Washington, DC. Her experience also includes legal internships with a large, nonprofit health care system and with the International Trade Administration of the US Department of Commerce. 

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