Patent litigation over biosimilars charges forward, with a new lawsuit filed on November 29 by Johnson & Johnson’s Janssen unit over Amgen’s efforts to bring a ustekinumab biosimilar to the marketplace.
Stelara is expected to be a hotly contested market, with five manufacturers completing phase 3 trials through the first half of 2023. The principal patent expiration is in September 2023. Amgen completed its phase 3 clinical trial last summer and is scheduled to complete a multiswitch interchangeability study in March 2023.
The US revenues for this interleukin 12/23 agent, used to treat autoimmune disorders including Crohn’s disease, ulcerative colitis, and psoriasis, were $5.9 billion in 2021, which represented a 13% increase over 2020.
Amgen has not officially announced a 351(k) filing for ABP 654, but in its November 2 third-quarter financial statement, it hinted that this might be the case, saying “A phase 3 study evaluating the efficacy and safety of ABP 654…in adult patients with moderate to severe plaque psoriasis has completed, and these data were submitted to the FDA to support U.S. approval.”
If true, the first interleukin biosimilar could be ready for marketing as early as the patent expiration in September 2023, and an interchangeability designation could follow in 2024.
Competition is expected to be fierce in this category, with Alvotech, Bio-Thera, Celltrion, Formycon, and Samsung Bioepis in the mix during the 2024 time frame.
In Other Biosimilar News
An article in JAMA Internal Medicine states that approvals of biosimilars with “skinny labels” (i.e., those approved for only some of the reference product’s indications) have saved Medicare $1.5 billion during the period from 2015 to 2020. This figure is based on utilization of five drugs. Two thirds of biosimilars are approved with skinny labels, including the adalimumab biosimilars. Though the adalimumab approvals are for limited indications, these skinny labels aren’t skinny at all–they represent the lion’s share of Humira® prescriptions today.