Some of the most widely prescribed and profit‑generating biologic therapies are set to lose exclusivity over the next few years, yet only a fraction have a biosimilar competitor currently in development. Patient advocates and industry groups are pushing for regulatory changes that will make it easier and cheaper to bring biosimilars to the market.
What does loss of exclusivity mean?
Drugmakers have patents on their products in the same way that other companies have patents on their inventions. Patents are an intellectua property right granted by the United States Patent and Trademark Office and can be issued anytime during the development of a drug. But for drugs, there is another layer of a variety of protections against market competition that are tied to FDA approvals. In effect, these “exclusivities” create monopolies for drug developers for a defined period of time with the goal of allowingthem to recoup their investment while at the same time eventually allowing competition. For small-molecule drugs, these exclusivities include five years of protection against generic competition for a new chemical entity and seven years if the drug is for an orphan disease (a conditions that affects fewer than 200,000 people in the U.S.). Drugmakers can also get an additional six months of exclusivity if they’v conducted pediatric studies requested by the FDA. Biologics, such as Humira and Keytruda, get 12 years of exclusivity. The thinking is that the monopolies should last long because biologics are more expensive to develop because they are more complex. Loss of exclusivity can refer to the expiration of a drug’s patent, the end of an exclusivity tied to an FDA approval, or both.
In total, 118 biologics in the U.S. are expected to lose patent exclusivity by 2034, representing an estimated $234 billion market opportunity for biosimilars, according to a report by IQVIA Institute published in 2025. Only 12 biosimilars were in development as of September 2024, a gap IQVIA dubbed the “biosimilar void.”
Alex Keeton, M.P.P., executive director of The Biosimilars Council, a trade group for biosimilar makers, said in an email to Managed Healthcare Executive (MHE) that biosimilars have worked to deliver more than $56 billion in savings in just over a decade. But there are no biosimilars under development for 90% of the biologics expected to lose exclusivity in the next 10 years. according to Keeton. His organization wants Congress to pass several pieces of legislation to “remove unnecessary roadblocks, foster competition, and unlock the full promise of a sustainable biosimilars market,” including the Biosimilar Red Tape Elimination Act, the ETHIC Act, and the Skinny Labels, Big Savings Act.
A number of the top‑selling therapies by revenue fall are losing patent protection, including Merck & Co.’s cancer immunotherapy Keytruda (pembrolizumab), Eli Lilly and Company’s diabetes drug Trulicity (dulaglutide), and Takeda Pharmaceutical Company Limited’s inflammatory bowel disease therapy Entyvio (vedolizumab), according to an analysis by IPD Analytics. More immediately, therapies such as Janssen Biotech’s autoimmune treatment Simponi (golimumab) and Genentech USA and Novartis Pharmaceuticals Corporation’s asthma and chronic idiopathic urticaria drug Xolair (omalizumab) are set to lose exclusivity in 2026.
Although the largest, best‑selling biologics are the most likely to attract biosimilar developers, the IQVIA analysis shows that pipeline activity drops off sharply once products fall below the “blockbuster” territory of drugs with sales greater than $1 billion annually.
Some of the reforms biosimilar advocates are pushing for focus on making development faster and less expensive without changing the basic safety bar. Recent FDA draft guidance would give companies more flexibility in generating comparison data for branded biologics, including allowing the use of certain foreign data, and would scrap earlier recommendations for clinical studies that compare the same biosimilar against multiple versions of the reference drug.
“We applaud the FDA as they continue to trust the science and advocate for streamlining biosimilar development, which will help biosimilar developers bring high-quality biosimilars to patients more quickly,” says John Murphy III, president and CEO of the Association for Accessible Medicines, the umbrella organization that includes the Biosimilar Council, in a news release.
Biosimilars differ from traditional generics because they are made from living cells and are not exact chemical copies, but FDA requires them to be “highly similar” to an approved biologic with no clinically meaningful differences in safety or effectiveness.
Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in 2010 to give FDA an abbreviated approval pathway for these follow-on biologics, with the aim of promoting competition, reducing healthcare costs and increasing patient access once originator exclusivity expires. The BPCIA was incorporated into Affordable Care Act legislation that former President Barack Obama signed into law in March 2010. Mainly because of intense patent litigation by drugmakers, it took five years for the first biosimilar to reach U.S. patients. In March 2015, the FDA approved Sandoz’s Zarxio (filgrastim‑sndz), a version of Amgen’s Neupogen (filgrastim) used to help prevent infections in certain patients with cancer. Since then, the FDA has approved more than 90 biosimilars across 20 molecules as of March 2026, with 67 launched, according to Samsung Bioepis, a biosimilar manufacturer that tracks U.S. pricing and market share in a quarterly report.
340B
Hospitals complicate the picture. Those that participate in the federal 340B Drug Pricing Program realize revenue by buying outpatient drugs at steeply discounted prices available to hospitals eligible for the program and then being reimbursed at higher prices. That difference can create an incentive to administer more expensive drugs. A 2025 analysis by HHS found that Medicare would have saved $55 million in 2023 if 340B hospitals had prescribed biosimilars at the same rate as other providers.
So-called patent thickets, or layers of overlapping patents that biosimilar developers must clear before they can launch, have caused delays in biosimilar launches. In a review of litigation involving 30 biosimilars, 377 patents were litigated in the U.S., according to an analysis published in DIA Global Forum in January 2026. These legal disputes corresponded with an average launch delay of 34 months after regulatory approval.
“Obtaining a new drug patent typically costs between $10,000 and $50,000, but challenging a patent through litigation typically costs over $1 million,” the analysis said. “[B]iosimilar developers face impractical litigation burdens that delay patient access and stifle competition.”
AbbVie’s strategy
The clearest test so far is Humira (adalimumab), AbbVie's anti-inflammatory drug that lost U.S. exclusivity in early 2023. Biosimilars were slow to gain ground at first, as payers and pharmacy benefit managers (PBMs) kept brand-name Humira in a preferred position on their formularies. By February 2026, Humira biosimilars, including private-label versions, had reached 60% of the market, according to Samsung Bioepis, a biosimilar manufacturer that tracks U.S. pricing and market share. Biosimilars of Johnson & Johnson’s Stelara (ustekinumab), which lost exclusivity more recently, held 27% as of late 2025.
AbbVie’s Humira brought in $688 million in the first quarter of 2026, down about 40% from a year earlier due to competition from biosimilars, yet the company’s total revenue rose 12% as two newer immunology drugs, Skyrizi (risankizumab) and Rinvoq (upadacitinib), replaced the lost sales.
“When I look at the current state of AbbVie’s business, the long-term outlook, and the pipeline's replacement power, we have never been in a stronger position,” Rob Michael, AbbVie’s chairman and CEO, said during the company’s first quarter earnings call.
Unlike the advent of generic medicines in the 1990s, when patients and physicians quickly moved to cheaper versions, biosimilar adoption has been “respectable” but slower, says Jeffrey Casberg, M.S., RPh, senior vice president of clinical pharmacy at IPD Analytics and a member of MHE’s editorial advisory board. He described the U.S. as now entering a second phase of biosimilar adoption, with the FDA requiring fewer clinical trials and PBM reforms starting to curb rebate strategies that kept some reference biologics in preferred positions.
“The market has been at least modestly successful in biosimilars in the first 10 years, maybe we were hitting singles and doubles in the early innings, but I think as we get into the later innings, maybe we’ll get some triples and home runs,” Casberg said.
The economics for biosimilar makers remain a central question as the next wave of high-profile drugs approaches loss of exclusivity, though FDA changes that reduce clinical trial requirements and clearer rules on interchangeability will help, he said.
“I think there is a chance that there will be some additional competition in the biosimilar market, and more companies will survive,” he says. “I’m going to be optimistic. I’ll try to be positive.”
Ryan Flinn is a healthcare writer based in Northern California.
