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aBLA Resubmissions: Xbrane’s Xlucane (ranibizumab) and Alvotech’s AVT05 (golimumab) and AVT06 (aflibercept)

by Robert S. Schwartz, Ph.D.
June 6, 2026

On June 3, 2026, Xbrane announced the resubmission of its aBLA for Xlucane (ranibizumab), a proposed biosimilar of Genentech’s Lucentis® (ranibizumab) after receiving a second Complete Response Letter (CRL) from the FDA in October 2025.  Xbrane previously submitted its Xlucane aBLA in April 2023, received a CRL in April 2024, and resubmitted the aBLA in December 2024 (previously reported Biosimilar Launch and Approval Updates – Tyenne® (tocilizumab-aazg), Xlucane™ (ranibizumab), Hercessi™ (trastuzumab-strf); aBLA Updates: Stelara® Biosimilar Steqeyma™ (ustekinumab-stba) FDA-Approval; Lucentis® Biosimilar Xlucane™ (ranibizumab) aBLA Resubmission).

On June 4, 2026, Alvotech and Teva announced the resubmission of aBLAs for AVT05 (golimumab), a proposed biosimilar of Janssen’s Simponi® / Simponi Aria® (golimumab), and AVT06 (aflibercept), a proposed biosimilar of Regeneron’s EYLEA® (aflibercept).  The aBLA for AVT05 was initially accepted in January 2025 and received a CRL in November 2025 (previously reported Alvotech and Teva Announce First FDA Acceptance of aBLA for Simponi® / Simponi Aria® (golimumab) Biosimilar; FDA Issues Complete Response Letter for Alvotech’s Simponi® (golimumab) Biosimilar AVT05).  The aBLA for AVT06 was initially accepted in February 2025 and received a CRL in December 2025 (previously reported FDA Accepts EYLEA® Biosimilar Application for Alvotech / Teva’s AVT06).

The companies expect the FDA to conduct a six-month review of the resubmitted applications.

Alvotech’s PGR2025-00085 against Regeneron’s U.S. Patent No. 12,168,036 related to EYLEA® has been instituted and is pending.  There are no pending patent disputes related to AVT05 or Xlucane.

Roche reported U.S. sales of 58 million CHF (approximately $73 million USD) for Lucentis® in 2025.

Johnson & Johnson reported U.S. sales of $1.2B for Simponi® / Simponi Aria® in 2025.

Regeneron reported EYLEA® U.S. sales of $2.75 billion and EYLEA® HD U.S. sales of $1.64 billion in FY2025.

For more information about these and other biosimilars, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

    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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