Eucrisa losing exclusivity?

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Accepted Answer

Eucrisa (tildrakizumab) and its coming loss of exclusivity

What is it?	A fully human monoclonal antibody that blocks interleukin‑23 (IL‑23), used mainly for moderate‑to‑severe plaque psoriasis. It is marketed by Amgen as Eucrisa.

1. Why “loss of exclusivity” matters

Patent protection: The primary patents covering Eucrisa (covering the drug’s composition, formulation, and use) are expected to expire around 2027. Until those expire, Amgen holds the right to prevent generic competitors from selling an identical molecule.
FDA product exclusivity: Biologics receive a 5‑year “data exclusivity” period starting from the filing of the biologic license application (BLA). For Eucrisa, the exclusivity period ran from April 2017 to April 2022. Once that ends, Amgen’s exclusive claim on the drug’s clinical trial data disappears, opening the door for biosimilar filings.
Patent thickets & secondary patents: Amgen also has a series of “secondary” patents (e.g., on specific manufacturing processes, formulation tweaks, or “use” patents). Some of these may still be in force beyond 2027, delaying biosimilar entry.

In short: “losing exclusivity” means that Amgen’s legal monopoly on the drug’s use and data is ending, making it legally permissible for other companies to file for a biosimilar once all patents lapse.

2. What this looks like for patients and prescribers

What you might see	How it could affect you
Biosimilar filings	Companies will file for regulatory approval (e.g., FDA biosimilar approval) after the primary patents expire.
Biosimilar approvals	Typically 1‑3 years after filing. If a biosimilar gets approved, the first‑in‑class product (Eucrisa) may still be “first‑in‑class” in terms of brand‑name coverage until the biosimilar is marketed.
Switching	Once a biosimilar is approved, prescribers may consider switching patients for cost savings, but decisions depend on insurance coverage, formulary placement, and patient preference.
Cost	Biosimilars often offer a price reduction (30‑70 %) relative to the brand product, which could lower copays or increase access.
Insurance formulary	Many payers will add the biosimilar to their step‑therapy list, sometimes requiring the brand first and then the biosimilar.
Monitoring	Because biosimilars are highly similar but not identical, patients may be monitored for rare adverse reactions when switching, although the FDA’s guidance says no additional monitoring is needed beyond standard safety surveillance.

3. Timeline (as of 2024)

Event	Date	Status
FDA 5‑year exclusivity ends	April 2022	Closed
Key patents expire	2027 (varies by patent)	Pending
First biosimilar filings	2024‑2025	Several companies (e.g., Amgen, Biogen, Pfizer, Sanofi) have filed or announced intent
First biosimilar approvals	2026‑2027	Expected, if no patent challenges prolong exclusivity
Commercial availability	2027‑2028	Likely after regulatory approval and patent clearance

Note: Patent litigation can extend the “effective exclusivity” period. If any of Amgen’s secondary patents are litigated, the biosimilar market could be delayed beyond the expected 2027–2028 window.

4. Practical tips

Stakeholder	What to do
Patients	Ask your dermatologist if switching to a biosimilar is an option; discuss the potential cost savings and monitor for any changes in efficacy or side effects.
Prescribers	Stay updated on which biosimilars have been approved and their formulary status. Discuss with patients the evidence that biosimilars are “highly similar” and that interchangeability can be safe and effective.
Insurers	Consider negotiating a step‑therapy approach that starts with the brand but allows a switch to a lower‑cost biosimilar after the first course of treatment.
Pharmacists	Keep track of the approval status of biosimilars and counsel patients about the differences (or lack thereof) in labeling and handling.

5. Bottom line

Eucrisa’s data exclusivity ended in 2022.
Primary patents will likely expire around 2027, after which biosimilar competitors can launch.
Patents and litigation might delay or accelerate this timeline.
When biosimilars become available, you can expect a significant price drop and greater access options.

If you have a specific question about a biosimilar’s availability, pricing, or how switching might affect you, feel free to ask!

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Eucrisa losing exclusivity?

1. Why “loss of exclusivity” matters

2. What this looks like for patients and prescribers

3. Timeline (as of 2024)

4. Practical tips

5. Bottom line