Biosimilars Business Roundup: June 2023

As the US biosimilar industry prepares for a busy summer, businesses worldwide make strides to elevate their biosimilars portfolio, from some business extending and strengthening their partnerships to new deals for adalimumab products ahead of US launches.

Gearing Up for Adalimumab

At the beginning of the month, Coherus Biosciences partnered with the Mark Cuban Cost Plus Drug Company to bring Yusimry, an adalimumab biosimilar launching on the US market in July 2023, to patients at a lower price.

Cost Plus Drugs, an online pharmacy created by SharkTank’s Mark Cuban, aims to bring low-cost generic drugs to the public, regardless of a patient’s health coverage status. The new partnership is the first time Cost Plus Drugs will offer a biologic to its customers.

Yusimry will be offered to patients at $569.27 plus dispensing and shipping fees. The biosimilar will be available with an autoinjector presentation featuring a 29-gauge needle and will be included in the Team Cuban Card prescription benefit program, allowing for patients to obtain their prescriptions from a local independent pharmacy at the same price they would get through the online platform.

The partnership led to AbbVie, the developer of Yusimry’s originator, filing a preliminary injunction against Coherus, alleging that Coherus’ partnership with Cost Plus Drugs infringed on a previous agreement between AbbVie and Coherus that granted the latter a nonexclusive license to commercialize Yusimry. Since the filing, AbbVie and Coherus have agreed to settle the dispute.

Additionally, SmithRx has become the first pharmacy benefit manager (PBM) to announce that it will cover Yusimry, which is one of 9 FDA-approved adalimumab products expected to launch in 2023. The PBM will offer the drug at more than a 90% discount from the originator (Humira) and is working with Cost Plus Drugs and Coherus to work out coverage options.

Ahead of the July adalimumab boom, when 8 adalimumab biosimilars are projected to launch in the United States, The Center for Biosimilars^® updated a series of articles prepping major stakeholders on the products that are coming down the pipeline, the differences between them, and how they can prepare for the large influx of new lower-cost products.

Partnerships and Policy

Alvotech and Advanz Pharma announced they would extend their partnership to commercialize 5 new biosimilars for European markets. Under the agreement, Alvotech will be responsible for development and commercial supply and Advanz Pharma will be in charge of registration and commercialization in Europe.

In addition to the development of an omalizumab biosimilar, which was the drug included in the original partnership, the expanded deal includes biosimilars for Simponi (golimumab) and Entyvio (vedolizumab), as well as 3 early-stage undisclosed biosimilar candidates.

New research has found the Medicare 340B program is slowing uptake of biosimilars by incentivizing use of more expensive biologics. The researchers investigated the 340B Drug Pricing Program’s impact on biosimilar uptake in hospital outpatient departments based on use of filgrastim and infliximab products from 2017 to 2019.

Using a regression discontinuity design to examine the impact of the 340B program on biosimilar administration, the researchers found substantial discontinuities in biosimilar use among hospitals just above the threshold compared with those just below it. The authors suggested for the program to consolidate billing codes to ensure biosimilars are reimbursed at the same rate as the reference product, which would make the lowest-cost product (ie, the biosimilar) the most profitable to prescribe.

Sandoz established a new roadmap to provide actionable steps, across 4 focus areas (approvability, acceptability, accessibility, and affordability) to overcome key challenges and increase biosimilar adoption globally. The Act4Biosimilars Action Plan is part of the Act4Biosimiliars initiative, which has the goal of increasing biosimilar adoption by at least 30 percentage points in 30-plus countries by 2030.