How many Biktarvy biosimilars are approved?

Drug Landscape tracks 2 approved Biktarvy biosimilars across global regulators. 0 additional applications are filed and 1 are in Phase 3.

Is Biktarvy still patent-protected?

All tracked patents on Biktarvy have expired in tracked territories.

What is a biosimilar?

A biosimilar is a biological medicine highly similar to an already-approved reference biologic (the originator), with no clinically meaningful differences in safety, purity, or potency. Approved via abbreviated regulatory pathways once the originator's data exclusivity and patents expire.

Last reviewed 2026-06-10 · How we verify

Biktarvy biosimilars

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Complete Biktarvy (Biktarvy) biosimilar landscape: 2 approved biosimilars, 0 filed, 1 in Phase 3. Sponsor, approval status, first approval date, and patent timeline for the originator.

2 approved 0 filed 1 Phase 3 All key patents expired

About Biktarvy

Biktarvy — originally marketed by East Carolina University. Area: Other.

Approved biosimilars (2)

Biosimilar	Sponsor	Phase	First approval	Country
Biktarvy Tab	Southampton Healthcare, Inc.	marketed
Biktarvy 50/200/25 Tab	Radboud University Medical Center	marketed

Filed biosimilars under regulatory review (0)

No biosimilars currently under regulatory review.

Phase 3 biosimilars (1)

Biosimilar	Sponsor	Phase	First approval	Country
BIKTARVY Tablets (BIK)	ViiV Healthcare	phase 3

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

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Every regulatory action on Biktarvy or any of its biosimilars:

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing