As Biosimilars Approach Their Second Decade, the Pipeline is Stuffed

Plenty is flowing through the biosimilar pipeline.

The current biosimilar pipeline is stuffed with candidates that could more than double the number of biosimilar options for patients in the United States and exponentially increase the success of biosimilars in their second decade.

The first biosimilar in the United States was approved in March 2015, just over nine years ago. In the interim, the FDA has approved 49 biosimilars for 15 originator drugs. However, not all of them have come on the market for a whole set of tangled reasons.

The challenges involved in bringing a biosimilar to market are numerous, such as development expense — variously estimated from $100 million to $300 million — costly patent litigation by originator companies, competition from other biosimilar compounds and “product hopping,” the term for the slight modification of originator products to lure away patients from biosimilars.

Nevertheless, biosimilar producers remain undaunted, and as biosimilars approach the 10-year mark in the United States, the biosimilar product pipeline is stuffed with potential new candidates for capturing market share from originator brand-name products and the biosimilars that are already out there on the market.

As of the beginning of 2024, there were 81 biosimilars for 23 different originator drugs, according to a report published by Cardinal Health. Thirty-nine had been approved by the FDA and are on the market, according to Cardinal’s tally.

Next year is shaping up to be a big year for biosimilars to Stelara (ustekinumab). Alvotech and Teva Pharmaceutical’s biosimilar to Stelara was approved by the FDA earlier this month, and the companies aim to launch their biosimilar, which they are selling under the name Selarsdi, early next year. Amgen’s Stelara biosimilar, dubbed Wezlana, is also expected to hit the market next year. It is a big market. Stelara generates roughly $7 billion annual sales revenue.

At least six originator products that do not already have biosimilar competition are being targeted by biosimilar companies. They include Xolair (omolizumab), an anti-inflammatory; Novolog (insulin aspart), a treatment for diabetes; Cosentyx (secukinumab), an anti-inflammatory; Entyvio (vedolizumab), a treatment for ulcerative colitis and Crohn disease); Eylea (aflibercept), a treatment for macular degeneration; and Perjeta (pertuzumab), a breast cancer drug

Among the most crowded of these pipelines is that for Eylea, which has at least eight biosimilar candidates in development, five of which have applications under FDA review as of this writing.

Here is a list of the eight Eylea biosimilars:

There were five Xolair biosimilars in the works in early January 2024, but none had reached the FDA review stage.

A single Novolog biosimilar candidate is under FDA review, although Europe has two approved insulin aspart biosimilars dating back almost four years.

In U.S. markets where originator products already face biosimilar competition, more biosimilars are on the way.

This is especially true for biosimilars of Prolia and Xgeva (denosumab, bone strength), which have at least 14 pipeline biosimilars. The first two were approved (Sandoz) in March of this year.

Stelara (anti-inflammatory) has at least nine more biosimilars in the pipeline, four of which are pending FDA approval.

Multiple biosimilars are in development for the cancer biologics Herceptin (trastuzumab) and Avastin (bevacizumab), and a handful of each are under FDA review.

Excitement over the popular weight loss drug Ozempic (semaglutamide), which garnered roughly $5.7 billion in U.S. sales last year, has prompted Hangzhou Jiuyan Gene Engineering to develop a biosimilar for sale on the Chinese market, where patents for Ozempic expire in 2026.

But in the United States, Ozempic is not considered a biologic because it meets the definition of a peptide, which has 40 or fewer amino acids, rather than a biologic, which has a longer chain of amino acids. Amino acids are the building blocks of proteins. In the United States, the patents on Ozempic are expected to afford this drug protection from generic competitors through 2031.