Tagged as: Coherus

HUMIRA (adalimumab) Biosimilar Launches

In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market:  Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA (adalimumab-bwwd); Coherus Biosciences’s YUSIMRY (adalimumab-aqvh); Celltrion’s YUFLYMA (adalimumab-aaty); Fresenius Kabi’s IDACIO (adalimumab-aacf); and Biocon’s HULIO (adalimumab-fkjb).  With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there…

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

Coherus and AbbVie File Dueling Motions for Injunctive Relief Relating to Coherus’s HUMIRA Biosimilar

Our readers may recall that ten HUMIRA biosimilars have been licensed to launch, with Amgen’s AMJEVITA the only one to launch to date and nine others set to launch starting in July 2023.  On June 1, 2023, Coherus issued a press release announcing “that the company plans to launch YUSIMRY™…

Read More

Coherus to Acquire Surface Oncology

On June 16, 2023, Coherus BioSciences, Inc. and Surface Oncology, Inc. announced that they have entered into a definitive merger agreement, where, at the closing, Coherus will acquire Surface Oncology, a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment.  Coherus’ Chairman and Chief Executive Officer said…

Read More

Coherus Biosciences Announces Approval of a Pegfilgrastim Autoinjector

On March 6, 2023, Coherus Biosciences announced FDA approval of an autoinjectable version of Udenyca, Coherus’ biosimilar to Amgen’s Neulasta (pegfilgrastim). Udenyca (pegfilgrastim-cbqv) was first launched in the US in January 2019 and is one of six FDA approved pegfilgrastim biosimilars. Udenyca is administered the day after a chemotherapy treatment…

Read More

Coherus Agrees to Acquire a Biosimilar EYLEA Candidate from Klinge Biopharma

On Jan 9, Coherus BioSciences, Inc. (“Coherus”) announced that it has agreed to acquire the exclusive commercialization rights to FYB203, a biosimilar referencing EYLEA (aflibercept) from Klinge Biopharma GmbH (“Klinge Biopharma”) in the US. The parties expect to complete the transaction in Q1 2023.  Coherus plans to file an abbreviated…

Read More

Amgen Releases 2022 Biosimilar Trends Report

On October 12, 2022, Amgen released its 2022 Biosimilar Trends Report. Since we posted on Amgen’s report preview in July, the total number of biosimilars that have been approved in the United States has increased from 36 to 39 (with the approval of Coherus’s CIMERLI (ranibizumab-eqrn) in August and Fresenius…

Read More

Coherus Announces FDA Approval of CIMERLI (ranibizumab-eqrn)

On August 2, 2022,  Coherus BioSciences, Inc. announced that the FDA approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar interchangeable with LUCENTIS® (ranibizumab injection) for all five indications, with 12 months of exclusivity.  Retina indications for which CIMERL is interchangeable include Neovascular (wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion…

Read More

Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen:  Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year.  As reflected by the assumption in the Company’s Full Year…

Read More

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….

Read More