Tagged as: Formycon

Recent Biosimilar Approvals

On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN.  AVZIZI is the fifth bevacizumab biosimilar approved by the FDA, behind Amgen’s MVASI (bevacizumab-awwb), approved in September 2017; Pfizer’s ZIRABEV (bevacizumab-bvzr), approved in June 2019; Amneal’s ALYMSYS (bevacizumab-maly), approved in…

Read More

Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation

Samsung Bioepis recently reported that it has signed a settlement and license agreement with Johnson & Johnson (“J&J”) in the United States relating to SB17, Samsung Bioepis’s ustekinumab biosimilar to J&J’s STELARA®. If SB17 is approved by the FDA, the license period in the United States will begin on February…

Read More

Regeneron Sues Formycon AG for Proposed Biosimilar of EYLEA in West Virginia District Court

Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 29, 2023, against Formycon AG (“Formycon”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 39 patents under the BPCIA based on Formycon’s submission of an aBLA for FYB203, a proposed biosimilar of EYLEA (aflibercept). …

Read More

Formycon Enjoined From Manufacturing FYB202 Biosimilar of STELARA in Germany

As previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after successful regulatory approvals. The European Medicines Agency accepted Formycon’s Marketing Authorization Application for FYB202 on September 29, 2023. It was recently…

Read More

Formycon Announces FDA Acceptance of the aBLA for Its Aflibercept Biosimilar

On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon’s candidate biosimilar to Regeneron’s EYLEA® (aflibercept).  As we previously reported, when Formycon submitted its aBLA in June 2023, it became the second biosimilar developer to announce…

Read More

Celltrion Stelara (Ustekinumab) Settlement With J&J

It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to launch the product in the U.S. market on March 7, 2025, if approved by FDA. This settlement…

Read More

Formycon/Fresenius Kabi and Samsung Bioepis Settlements with J&J and Janssen Biotech regarding Ustekinumab

On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed by J&J.  In February 2023, Formycon announced its entry into a global license agreement with Fresenius…

Read More

Formycon and Celltrion Announce FDA Submission of aBLAs Seeking Approval to Market Aflibercept Biosimilars

On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates.  Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s submission in October 2021.  As…

Read More

Formycon Announces Details for Pembrolizumab Biosimilar

This week Formycon AG (“Formycon”) announced details of its previously undisclosed pipeline project for FYB206, Formycon’s biosimilar of KEYTRUDA (pembrolizumab). KEYTRUDA is approved for the treatment of advanced melanoma, lung and other types of carcinoma. According to the press release, Formycon fully owns the development and commercialization rights for FYB206,…

Read More

Formycon Announces Comparable Efficacy of Ustekinumab Biosimilar to Reference Product STELARA in Phase III Study

This week Formycon AG (“Formycon”) announced positive preliminary efficacy and safety data from the VESPUCCI Phase III clinical trial for FYB202, Formycon’s biosimilar version of STELARA (ustekinumab). The Phase III study was a multi-center, randomized, double-blinded, comparative study of patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The clinical…

Read More