FDA Slashes Biosimilar Costs 2025 – Trump USPTO Blocks Savings

In a major win for patients facing sky-high drug bills, the FDA announced plans on October 29, 2025, to dramatically speed up and reduce the cost of approving biosimilars — the near-identical, far-cheaper versions of blockbuster biologic drugs like Humira, Keytruda, Enbrel, and Xolair.Under the new FDA guidance set to take effect in 2026, companies could save up to $100 million per drug by skipping expensive human trials and relying instead on advanced lab testing. This could cut development time in half and finally deliver savings of up to 90% on some of the most expensive medicines in America.

Why This Matters: The Massive Cost of Biologics

Biologics = only 5% of prescriptions but over 50% of total U.S. drug spending ($600+ billion/year)
Humira (arthritis): ~$6,500–$7,000 per month
Keytruda (cancer): generated $17 billion for Merck in just one quarter
Enbrel (autoimmune): $7,000–$9,000 monthly without insurance

Biosimilars are the #1 proven way to crush these prices — but they’ve been blocked for years.

The Huge Roadblock: Trump-Era Patent Office Changes

While the FDA is opening the door, the U.S. Patent and Trademark Office (USPTO) under the current administration is slamming it shut.

New 2025 USPTO rules have:

Denied nearly all requests for fast patent challenges (Inter Partes Review)
Made it 10–20× more expensive to fight weak patents than in Europe
Allowed Big Pharma to keep filing hundreds of secondary patents — the infamous “patent thicket”

Real-World Examples of the Damage

Drug	FDA Approved Biosimilar	Actual U.S. Launch	Reason for Delay
Humira	2016	2023 (9 versions)	180+ patents blocked entry
Enbrel	2016	Not before 2029	Patent wall still standing
Keytruda	Biosimilars in pipeline	Launch uncertain	Merck defending dozens of patents

What Patients Are Saying

“I’ve been on Enbrel since 2007. Even with Medicare, I was paying thousands out-of-pocket every year until the IRA cap kicked in. A cheaper version would change my life — if it ever gets here.”
— Judy Aiken, retired nurse, Maine

Will Cheaper Drugs Ever Arrive?

Only 10% of the 118 biologics losing patent protection this decade currently have biosimilars in active development — because the patent system makes it financially suicidal to even try.

Experts warn that without reversing the USPTO’s anti-competitive stance, the FDA’s historic reforms will deliver zero real-world savings for American patients.

Bottom Line for 2025–2026

✅ FDA: Doing everything possible to fast-track cheaper drugs
❌ USPTO: Making patent challenges almost impossible
💊 Patients: Still waiting for relief