New Biosimilars Continue to be Approved But Uptake Varies by Class

Biosimilars launched to date account for 23% of molecule volume, but uptake has varied across therapeutic areas, according to the newest Use of Medicines report by IQVIA Institute for Human Data Science.

For example, uptake of biosimilars on the market for at least three years varies from 8% for insulin lispro to 82% for bevacizumab, which are biosimilars of Avastin.

There are currently five Avastin biosimilars of Avastin, which are used to treat certain cancers, including colorectal cancer, non-small lung cancer, renal cell cancer and ovarian cancer. The most recent biosimilar that references Avastin —Avzivi — was approved by the FDA on Dec. 7, 2023. Developed by the Chinese company Bio-Thera Solutions, Avzivi (bevacizumab-tnjn) is marketed by Sandoz.

Biosimilars of the arthritis drug Humira (adalimumab) achieved just 2% of volume as of the end of 2023, but biosimilars of Lucentis (ranibizumab), which treats macular degeneration, is now at 45% by end of 2023 after a slow start in 2022. IQVIA officials suggested that the impact on a net basis from the Humira biosimilars will continue this year and into 2025.

By Febuary 2024, biosimilars of Humira reached a market share of 4%, according to a Samsung Bioepis Quarterly Biosimilar Market Report released last month.

Of these, the Humira biosimilar, Hadlima had the highest market share, 1.4%. Hadlima is offered with a low wholesale acquisition cost of 85% off Humira’s list price of $6,922 in 2023. Hadlima, developed by Organon and Samsung Bioepis, launched in the United States in July 2023. It is available in both citrate-free high concentration and citrate-containing low concentration.

The Humira biosimilars have faced more barriers to adoption related to brand contracting and PBM controls, according to an analysis by the Biosimilars Council of IQVIA data.

The uptake of the Humira biosimilars has been driving by small payers not affiliated with the larger PBMs. The larger PBMs prefer Humira with its rebates and fees based on the higher list. Those that do provide coverage with the biosimilars include them on parity with Humira.

Related: Humira Biosimilars Have a Slow Uptake, Finds Samsung Bioepis Report

The Samsung Bioepis report suggests that on average, biosimilars gain 53% of market share within three years of launch. Therapeutics in oncology, ophthalmology and the pegfilgrastim have the fastest uptake, reaching 75% market share in three years. Among the slowest uptake are the immunology, filgrastim, epoetin alfa and insulin glargine products, reaching 23% market share by year three.

Projecting to 2028, IQVIA predicts biosimilars will contribute to net price growth declines between 1% and 4%. Over the next five years, several branded biologics are expected to lose patent protection. The report predicted that loss of exclusivity for biologics and small generics will result in $93.6 billion in spending reductions by 2028.

Already, some of these have seen FDA approvals for the biosimilars. Earlier this week, the FDA approved two biosimilars that are interchangeable with Eylea (aflibercept). Biocon Biologic’s Yesafili (aflibercept-jbvf) and Samsung Bioepis’ Opuviz (aflibercept-yszy) are approved to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy.

In March 2024, the FDA approved Wyost and Jubbonti as the first biosimilars for denosumab that reference Amgen’s osteroporisis drug Prolia and the bone cancer drug Xgeva. Developed by Sandoz, both biosimilars are interchangeable with the reference products for all indications.

Several Stelara biosimilars have also been approved and are expected to launch next year, including Alvotech’s Selarsdi, Amgen’s Wezlana

In March 2024, the FDA approved Fresenius Kabi’s Tyenne as both an IV and subcutaneous formulations. In In September 2023, the FDA approved Biogen’s IV formulation biosimilar, Tofidence. Additionally, in January 2024, Celltrion USA completed its biologic license application to the FDA for CT-P47, its Actemra biosimilar in both intravenous and subcutaneous formulations.

Closer to 2028, IQVIA expects biosimilar introductions for Opdivo (nivolumab) and Keytruda (pembrolizumab), two blockbuster PD-1/PD-L1 therapies with several oncology indications.