The loss of exclusivity for AbbVie's Humira in the United States is a complex topic with multiple dates depending on the specific indication and the types of intellectual property involved.
When Did Humira's Key Patents Begin to Expire?
The earliest U.S. patents for Humira, covering its composition of matter, began to expire around 2016. However, AbbVie held numerous secondary patents, including method of use and formulation patents, which extended its market exclusivity for longer periods [1].
How Does Humira's Patent Exclusivity Work?
AbbVie strategically filed and defended a broad portfolio of patents for Humira. These secondary patents were designed to protect the drug from generic competition even after the primary composition of matter patent expired. Challenges to these patents have been a significant part of Humira's lifecycle.
When Did Humira's U.S. Market Exclusivity Actually End?
While the first patents expired years ago, the U.S. market exclusivity for Humira effectively ended in late 2023, with the launch of the first biosimilars [2]. This was due to a settlement agreement between AbbVie and several biosimilar manufacturers that allowed for the launch of their products in the U.S. after July 1, 2023 [3].
What Are Humira Biosimilars?
Biosimilars are biological products that are highly similar to an already approved biological product, known as the reference product, with no clinically meaningful differences in safety, purity, and potency. In the case of Humira, several companies developed biosimilar versions after AbbVie's patent protections weakened.
Which Companies Are Offering Humira Biosimilars in the U.S.?
Following the loss of exclusivity, companies like Amgen (Amjevita), Boehringer Ingelheim (Cyltezo), Sandoz (Hyrimoz), and others have launched their biosimilar versions of adalimumab, the active ingredient in Humira, in the United States [4][5].
What Are the Implications of Humira's Loss of Exclusivity?
The introduction of biosimilars is expected to significantly reduce the cost of adalimumab treatment in the U.S. This could lead to increased patient access and substantial savings for healthcare systems and patients. Competition from biosimilars can also drive innovation in the pharmaceutical industry.
How Did AbbVie Respond to Biosimilar Competition?
AbbVie has actively defended its intellectual property through litigation and has also developed its own higher-priced formulation of Humira (Humira High Concentration) and has been developing new biologic assets to offset potential revenue loss from biosimilar competition [6].
How Does Humira's Exclusivity Timeline Differ in Europe?
Humira lost exclusivity in Europe much earlier than in the United States. Biosimilars began entering the European market as early as 2018, following the expiry of relevant patents in that region [7].
Sources:
[1] https://www.drugpatentwatch.com/drugs/adalimumab/
[2] https://www.drugpatentwatch.com/news/humira-biosimilar-launch-in-the-us-expected-in-2023/
[3] https://www.drugpatentwatch.com/news/abbvie-and-amgen-settle-humira-patent-dispute/
[4] https://www.drugpatentwatch.com/biosimilars/adalimumab/
[5] https://www.drugpatentwatch.com/biosimilars/
[6] https://www.drugpatentwatch.com/news/humira-biosimilar-challenges-and-abbvies-strategy/
[7] https://www.drugpatentwatch.com/news/humira-biosimilars-in-europe-a-new-era-of-competition/