BIO-THERA

BIO-THERA

approved_indications FDA Approved Biologics and Pending Applications

Avzivi®

bevacizumab-tnjn
aBL 761198

Immgolis / Immgolis Intri

golimumab-sldi
aBL 761452

Starjemza®

ustekinumab-hmny
aBL 761419

Tofidence

tocilizumab-bavi
aBL 761354

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Avzivi® (bevacizumab) (Bio-Thera Solutions) (July-2024)Gotenfia (golimumab) (STADA / Bio-Thera) (February-2026)Tofidence (tocilizumab) (Biogen / Bio-Thera) (June-2024)Usgena (ustekinumab) (Bio-Thera / STADA) (November-2025)Usymro (ustekinumab) (Bio-Thera / Gedeon Richter) (August-2025)

approved_indications Inter Partes Review Proceedings

SIMPONI / IMMGOLIS / IMMGOLIS INTRIIPR2026-00256
IPR2026-00257
IPR2026-00258
IPR2026-00259

approved_indications U.S. Patent Litigations

ACTEMRA / TOFIDENCE1:23-cv-11573 (D. Mass.)
SIMPONI / IMMGOLIS / IMMGOLIS INTRI1:26-cv-00222 (D. Del.)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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