MRx Pipeline +: Humira Biosimilars Launch

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Humira® Biosimilars Launch

At Magellan Rx Management, we are dedicated to providing you with timely and valuable information surrounding biosimilars.

Adalimumab (Humira) was approved by the United States (US) Food and Drug Administration (FDA) 2 decades ago. This injectable tumor necrosis factor-blocker has amassed indications across a host of autoimmune conditions. Now almost 7 years after approval of its first biosimilar, the highly anticipated US market launch of the first Humira biosimilar is imminent. Availability of biosimilar Humira is predicted to impact market dynamics.

• There are a total of 8 FDA-approved Humira biosimilars and others await approval.

• Amgen’s Amjevita™ 50 mg/mL is slated to be first-to-market on January 31, 2023.

• Starting in July 2023, a wave of Humira biosimilars is forecasted to hit the US market, including at least 1 interchangeable biosimilar and potentially high concentration (100 mg/mL) formulations.

Earliest Anticipated 2023 Humira Biosimilars


Launch Dates

All biosimilars listed above have a 50 mg/mL concentration unless noted. Products without citrate or citric acid can make injections less painful for patients.

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BIOSIMILAR COMPANY FDA APPROVAL DATE CURRENTLY INTERCHANGEABLE CITRATEFREE EARLIEST ANTICIPATED LAUNCH FDA-Approved Amjevita (adalimumab-atto) Amgen September 2016 No Yes January 31, 2023 Cyltezo® (adalimumab-adbm) Boehringer Ingelheim August 2017 Yes Yes July 1, 2023 Hadlima™ (adalimumab-bwwd) Samsung Bioepis/ Organon July 2019 (50 mg/mL) August 2022 (100 mg/mL) No No (50 mg/mL) Yes (100 mg/mL) July 1, 2023 Yusimry™ (adalimumab-aqvh) Coherus December 2021 No Yes July 1, 2023 Hyrimoz® (adalimumab-adaz) Sandoz October 2018 No No July 2023 Hulio® (adalimumab-fkjp) Biocon July 2020 No Yes July 2023 Idacio® (adalimumab-aacf) Fresenius Kabi December 2022 No Yes July 2023 Abrilada™ (adalimumab-afzb) Pfizer November 2019 No Yes November 2023 Pending FDA Approval Hyrimoz HCF Sandoz Pending, March to April 2023 (100 mg/mL) No Yes July 2023 AVT02 Alvotech Pending, April 13, 2023 (100 mg/mL) No Yes July 2023 Yuflyma Celltrion Pending (100 mg/mL) No Yes July 2023

A biosimilar is a biologic that is highly similar and has no clinically meaningful differences from an existing FDAapproved reference product. Interchangeability designation allows for automatic substitution of a biosimilar for the reference product at the pharmacy without consulting the prescriber, depending on state laws.

Cyltezo is currently the only FDA-approved Humira biosimilar that is interchangeable. Pfizer and Alvotech, are seeking interchangeability for Abrilada and AVT02, respectively, with applications accepted by the FDA. Additional manufacturers may be investigating and/or seeking interchangeability.

Humira biosimilars are approved for most of the same indications as Humira. They are approved in different strengths and presentations as outlined in the US FDA’s Purple Book – a database of approved biologics including biosimilars. Abbvie’s reference Humira is available in 50 mg/mL (low) and 100 mg/mL (high) concentrations.

The biosimilar pipeline is fluid. Earliest anticipated launch dates may vary and be subject to change. Details presented are based on available public information. The content above is not all-inclusive.


2 | 2023 Magellan Rx Management, LLC. All rights reserved. MRX1468_0123
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