Eye on Pharma: First PBM to Cover Yusimry; Celltrion to Test Ocrevus Biosimilar; Another Stelara Settlement

SmithRx becomes the first pharmacy benefit manager (PBM) to announce that it will cover Yusimry, 1 of 9 FDA-approved adalimumab biosimilars launching in 2023; Celltrion Healthcare receives a thumbs-up from the FDA to test a biosimilar for Ocrevus; Alvotech and Teva Pharmaceuticals settle with Johnson & Johnson over their biosimilar referencing Stelara.

SmithRx to Cover Yusimry

Smith Rx, a San Francisco–based PBM, announced that it will offer Yusimry (adalimumab-aqvh) to its members for at an over 90% discount from the list price of the reference product (Humira). It is the first PBM to share that it will cover the biosimilar, which is expected to launch in July 2023.

Yusimry was developed by Coheus Biosciences and was approved by the FDA in December 2021 for several indications, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and Crohn disease. When it launches, it will be offered in a citrate-free, low-concentration formulation.

The PBM is working with the Mark Cuban Cost Plus Drug, an online pharmacy created by SharkTank’s Mark Cuban, which offers generic drugs at significant discounts. The pharmacy recently announced that it would partner with Coherus Biosciences to bring Yusimry to patients at $569.27 plus dispensing and shipping fees, marking the first time that Cost Plus Drugs has added a biosimilar to its list of prescriptions.

Celltrion to Test Ocrevus Biosimilar

Celltrion announced that the FDA approved the company’s investigational new drug (IND) application to conduct a phase 3 study evaluating CT-P53, an ocrelizumab biosimilar referencing Ocrevus, in patients with multiple sclerosis (MS).

According to a report from the Korea Economic Daily, the IND approval came about a month after Celltrion submitted the application in May 2023. Celltrion is planning to conduct comparative studies evaluating the efficacy, pharmacokinetics, and safety between CT-P53 and the reference product in 512 patients with relapsing-refractory MS.

“With the clinical approval of our new pipeline product CT-P53 in the United States, we are entering the main clinical process and preparing for entering the US ocrelizumab market, which is estimated to be over $4.7 billion…. We will do our best to accelerate the phase 3 clinical trials and make CT-P53 a first mover in the Ocrevus biosimilar market,” a Celltrion official commented.

Celltrion is also working on applications for approval for 5 other biosimilars, including an omalizumab product (CT-P39), an ustekinumab biosimilar (CT-P43), an aflibercept biosimilar (CT-P42), a denosumab candidate (CT-P41), and a tocilizumab product (CT-P47).

Alvotech and Teva Settle Over Stelara Biosimilar

Alvotech has announced that the company and its US partner, Teva Pharmaceuticals, have reached a settlement and license agreement with Johnson & Johnson (J&J). The agreement was in reference to Alvotech and Teva's ustekinumab biosimilar (AVT04), which references J&J's Stelara (reference ustekinumab).

The settlement postpones Alvotech and Teva’s anticipated launch date for AVT04 in the United States from late 2023 to February 21, 2025. It is the second settlement regarding J&J and an ustekinumab biosimilar manufacturer after Amgen announced its agreement in May 2023.

Representatives from Alvotech and Teva commented on the announcement with positivity.

“We are delighted to have secured a US license date for our second biosimilar candidate in the US, and I believe this exemplifies our multiproduct approach to biosimilars globally,” said Robert Wessman, chairman and CEO of Alvotech.

“Biosimilars are a key component of Teva’s short and long-term strategy…. Today’s announcement is another step forward in our partnership with Alvotech, who shares our commitment to lower the cost burden of biologics on the health care system,” noted Sven Dethlefs, PhD, executive vice president, North America Commercial, at Teva.

Ustekinumab products are human monoclonal antibodies that target interleukin (IL)-12 and IL-23 for the treatment of moderate to severe plaque psoriasis, Crohn disease, ulcerative colitis, and psoriatic arthritis.