Sun Pharma’s announcement this week that it would drop almost $12 billion to buy drugmaker Organon points to an emerging dynamic in pharma: a race to the top of the swelling biosimilar market.
The FDA over the last several years has prioritized biosimilar approvals in an effort to introduce competition to the brand-name biologic market, lowering prices through healthy rivalry. In a press release from Sun yesterday, the Indian drugmaker said the deal would help the company’s “entry into biosimilars as a top-10 global player.”
The push for more biosimilars in the U.S., which has been seen as both an opportunity for new entrants and a headache for drugmakers whose branded blockbusters face incoming competition, led to the the first approval for an American copycat in 2015 when Sandoz’s Zarxio, a reference to Amgen’s Neupogen, gained an FDA nod. But that initial thrust was slow to pick up as both the agency and drugmakers navigated the complex science and regulatory landscape of biosimilars, said Linda Huber, an intellectual property partner at law firm Nixon Peabody.
“Back in 2015 with the original guidance, biosimilars were still somewhat new for the FDA to approve because biologics are much more complex than a small molecule drug,” Huber said. “So the approach was to be more cautious about ensuring safety and interchangeability to meet a rigorous standard.”
"Putting a cap on just one patent per patent family, while well intended, might be a little too extreme."
Linda Huber
Intellectual property partner, Nixon Peabody
As biologic understanding advances and biosimilars prove to be a viable alternative to pricey brand name drugs, that dynamic is changing, Huber said. Companies like Sandoz, Pfizer and Amgen lead the biosimilars market, leveraging biologic expertise and deep pockets as the sands begin to shift. Around 90 biosimilars have now been approved by the FDA as of the beginning of this year, according to the Generic and Biosimilars Initiative.
“A lot has happened since 2015, and with all the historical experience of the last 10 years, there’s a growing comfort level,” Huber said, pointing to the updated guidance in March that lowers the bar for clinical evidence.
Meanwhile, the U.S. biosimilar push has also shone a spotlight on the ongoing challenges around patent thickets.
A war on patent thickets
The difficult balance between brand name and biosimilar drugs requires an opportunity for return on investment during a drug’s exclusivity window while eventually allowing copycats to bring competition into the market.
But some drugmakers have been accused of forming “thickets” of patents around a single product to keep biosimilars at bay. A famous example is AbbVie’s Humira, which was protected by more than 100 patents for years until the company settled with several biosimilar makers to allow market entry in 2023, slashing Humira’s sales numbers significantly in the aftermath.
The patent thicket approach has been under fire from U.S. regulators as the push for biosimilars intensifies, and a 2025 article from FDA Commissioner Dr. Martin Makary calls for “breaking the biosimilar bottleneck.” Makary noted that the goals of the original Biologics Price Competition and Innovation Act of 2010 were not being met, with biosimilars making up only about 23% of the market.
Makary noted at the time that patent thickets “cause marketing delays due to patent litigation and create an average gap of 2.3 years (for wins) to 16.5 years (for losses) between brand patent expiration and biosimilar launch.” Over the years, efforts like the Affordable Prescriptions for Patients Act have sought to limit patents to particular groupings.
A pendulum swing too far in any direction threatens to disrupt the careful balance associated with drug patents, though, Huber warns.
“Where an improved product affects patient care, it’s fair for innovator companies to enforce their rights to exclusivity, and putting a cap on just one patent per patent family, while well intended, might be a little too extreme,” Huber said. “There’s probably some happy median number that would be a better fit where these patent thickets could be litigated.”
What Huber sees now are a greater number of validity challenges for drug patents.
“The current trend is to lock down the interpretation of valid patents, and narrowing that definition,” Huber said.
The latest FDA guidance making biosimilar development and regulation more flexible is starting to balance the scales.
“This current guidance removes one of the financial hurdles for more biosimilars to come on the market, and I think overall it’s going to push it toward more access for patients,” Huber said, pointing to looser requirements on data to cut down on trial costs from a regulatory standpoint.
That won’t stop the court fights, however.
“You’re going to see more biosimilars trying to come in, and the fact of the matter is, the litigation is going to exist,” Huber said. “Each biosimilar is going to face some type of negotiation for entry or litigation to slow down or stop it, so both sides are going to be more involved in that process.”
Simpler biologics such as peptides and some antibodies are the lower hanging fruit most at risk of biosimilar entry, while complex areas like CAR-T cell therapy and stem cells will be more difficult to replicate, Huber said.
And as the industry wrestles with the balance between innovation and patient access, the overall mission should be to satisfy all of the players involved, Huber said.
“There is a unified drive, ultimately, to make biologics cheaper for the patient,” Huber said.
