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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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FDA Accepts Alvotech’s BLA Supporting Interchangeability for ATV02, a High Concentration, Citrate-Free Biosimilar Candidate for Humira®

Alvotech Holdings S.A. (“Alvotech”) announced on February 28th that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes new data supporting interchangeability between ATV02 and Humira. According to Alvotech’s press release, the data are from a…

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Coherus Announces FDA Approval of YUSIMRY (adalimumab-aqvh)

Today, Coherus BioSciences, Inc. announced that the FDA approved YUSIMRY (adalimumab-aqvh), a biosimilar of AbbVie’s HUMIRA product.  YUSIMRY is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.  According to the press release, Coherus plans to launch YUSIMRY in the U.S….

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Ascletis and Suzhou Alphamab Expand their Partnership into Worldwide License Agreement for ASC22 (Envafolimab) to Treat Hepatitis B and Other Viral Diseases

Ascletis Pharma Inc. (Ascletis) and Suzhou Alphamab Co., Ltd. (Suzhou Alphamab) jointly announced that Ascletis’ subsidiary and Suzhou Alphamab have entered into an exclusive worldwide licensing agreement (excluding Greater China) for ASC22 (Envafolimab) to treat viral diseases, including Hepatitis B.  According to the press release, ASC22, also known as KN035,…

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