Tagged as: Formycon

Formycon AG Acquires Biosimilar Assets Ustekinumab and Ranibuzumab

On May 10, 2022, Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) announced that they have closed a transaction regarding the biosimilar assets FYB201 (ustekinumab) and FYB202 (ranibuzumab).  According to the press release, Formycon has acquired 100% of the rights in FYB202, a biosimilar candidate for STELARA®, and ATHOS’s 50% stake…

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Biosimilar Deal Watch: Formycon/ATHOS, Fresenius/mAbxience/Ivenix, and Intas/Axantia

It has been a busy last few weeks for biosimilar developers, with multiple deals announced. On March 29, 2022, it was announced that Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) have agreed to merge their development activities in the area of biosimilars through a long-term strategic partnership.  Formycon will acquire…

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Recent Launches – Formycon, bioeq and Boryung, Samsung Bioepis

On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration.  FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases.  If approved, Coherus…

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Formycon and Biocon Biologics/Viatris Share Recent Biosimilars Development News

On March 1, 2021, Formycon announced that it plans to resubmit its BLA for its Lucentis® Biosimilar Candidate FBY201 (ranibizumab) in the first half of 2021.  Formycon expects to submit its application to the EMA soon thereafter, and will also seek approval in Canada, Australia, the United Kingdom and Switzerland….

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Revance Therapeutics, Mylan, and Formycon Announce Updates to Their Biosimilar Plans

Revance Therapeutics, Mylan, and Formycon have announced updates to their biosimilar plans.  In the Q1 2020 Earnings Conference Call on May 7, 2020, Revance updated investors on the biosimilar to BOTOX® program in potential partnership with Mylan.  Revance informed investors that Mylan had requested additional information from Revance, and would…

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New Phase I Clinical Trials for Two Proposed Ustekinumab Biosimilars

Over the last two weeks, NeuClone and Formycon announced updates regarding their respective ustekinumab biosimilars (reference product, Stelara). On October 17, 2019, NeuClone announced that it has launched a Phase I clinical trial of its ustekinumab product, NeuLara.  NeuClone stated that the Phase I clinical trial is a “single-dose, double-blind, randomised,…

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