AbbVie Settles With Mylan to Delay Humira Biosimilar in U.S.
AbbVie, Inc. ABBV has signed a non-exclusive licensing deal with Mylan MYL regarding the latter’s proposed biosimilar version of AbbVie’s blockbuster arthritis drug, Humira, in the United States. Per the agreement, Mylan will have a license to launch its biosimilar Humira in the United States and in various other countries, excluding Europe, on Jul 31, 2023.
Per the terms of the settlement, Mylan will pay royalties to AbbVie once its cheaper version is launched. AbbVie will make no payments to Mylan.
AbbVie has similar licensing deals with Amgen, Inc. AMGN and Samsung Bioepis. While Amgen can launch Amjevita, its biosimilar version of Humira in the United States on Jan 31, 2023, Samsung Bioepiscan launch Imraldi, its biosimilar version on Jun 30, 2023. While Amgen and Samsung Bioepis’biosimilar versions are already approved by the FDA, that of Mylan is yet to gain FDA approval.
AbbVie made it clear that Mylan's U.S. license will not be accelerated by Amgen's or Samsung Bioepis' biosimilar launch. In most countries of Europe, Samsung Bioepis’ partner Biogen BIIB and Amgen have license to launch their biosimilar versions from Oct 16 this year.
Humira is the key driver of AbbVie’s revenues, accounting for around 65% of its total sales. Currently approved for 13 indications, Humira sales have increased consistently — 11.7% in 2015, 16.1% in 2016 and 14.6% in 2017 — backed by robust demand trends. The product continues to see strong growth in the dermatology and gastroenterology markets. The company expects Humira sales to approach $21 billion in 2020.
Other than, Amgen, Mylan and Samsung Bioepis, Coherus BioSciences, Boehringer Ingelheim, Novartis’ Sandoz and Pfizerare also looking to get approval for a biosimilar version of Humira. In May, June and July, the Patent Trial and Appeal Board (PTAB) ruled against AbbVie on five inter parties review (IPR) challenge filed by Coherus and Boehringer Ingelheim, invalidating three AbbVie patents for Humira. AbbVie has appealed the decision. The entry of biosimilars will have a huge impact on AbbVie’s financials.
However, AbbVie has successfully struck licensing deals with three companies to protect its revenues from Humira. Per settlements with Amgen, Mylan and Samsung Bioepis, biosimilar entry into the United States has been delayed until2023, which gives AbbVie more time to strengthen its pipeline with products that are capable of making up for the expected sales decline when Humira biosimilars are launched.
AbbVie’s stock has declined 1.4% this year so far compared with the industry’s decline of 1.7%.
AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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