Yusimry (adalimumab-aqvh) / Nanjing King-Friend Bio - LARVOL DELTA

A Single-Center, Randomized, Single-Blind, Single-Dose, Parallel-Group Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants under Fasting Conditions (ChiCTR) - P1 | N=238 | Not yet recruiting | Sponsor: Hopeshine-Minsheng Hospital of Xinzheng; Nanjing King-friend Biochemical Pharmaceutical.Co.,Ltd.

New P1 trial • Immunology

Coherus BioSciences Reports Second Quarter 2024 Financial Results and Provides Business Update (Coherus Press Release) - "Net revenue was $65.0 million during the three months ended June 30, 2024, and included $50.9 million of net sales of UDENYCA, $3.8 million of net sales of LOQTORZI, which was launched on January 2, 2024, $3.8 million of net sales of YUSIMRY, which was divested to Hong Kong King-Friend Industrial Company Ltd. ('HKF') on June 26, 2024, and other revenue of $6.5 million which included the $6.3 million up-front cash payment received for the outlicense to Apotex, Inc. of the Canadian rights to LOQTORZI on June 27, 2024."

Sales • Chemotherapy-Induced Neutropenia • Immunology • Inflammatory Bowel Disease • Nasopharyngeal Carcinoma • Rheumatoid Arthritis

Meitheal Pharmaceuticals Strengthens Biologics Portfolio with an Exclusive Commercial Licensing Agreement for YUSIMRY, a Biosimilar of Humira (Businesswire) - "Meitheal Pharmaceuticals...announced it has gained exclusive commercial rights in the U.S. to YUSIMRY (adalimumab-aqvh), a biosimilar of Humira (adalimumab), through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd...HKF has acquired worldwide rights to YUSIMRY through an asset purchase agreement with Coherus BioSciences, Inc. Under the agreement, HKF gains substantially all assets related to YUSIMRY, including any results of development and regulatory activities, in exchange for an upfront cash payment of $40,000,000....Meitheal will work closely with Coherus to ensure a seamless transition of existing YUSIMRY operations, including the existing and comprehensive support hub for patients and healthcare providers."

Licensing / partnership • Ankylosing Spondylitis • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Coherus BioSciences Reports First Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Product-specific, permanent J Code has been granted by the Centers for Medicare and Medicaid Services and will take effect July 1, 2024....Net revenue was $77.1 million during the three months ended March 31, 2024, and included $42.7 million of net sales of UDENYCA, $2.0 million of net sales of LOQTORZI, which was launched on January 2, 2024, $3.9 million of net sales of YUSIMRY, and $28.2 million of net sales of CIMERLI, which was divested to Sandoz on March 1, 2024. Net revenue was $32.4 million during the three months ended March 31, 2023."

Reimbursement • Sales • Immunology • Oncology • Ovarian Cancer

Coherus BioSciences Reports Fourth Quarter, Full Year 2023 Financial Results and Provides Current Business Update (GlobeNewswire) - "CIMERLI net sales of $52.4 million in the fourth quarter and $125.4 million in FY 2023....Net revenue was $91.5 million during the three months ended December 31, 2023 and included $36.2 million of net sales of UDENYCA, $52.4 million of net sales of CIMERLI, $2.2 million of net sales of YUSIMRY which was launched in July 2023 and $0.6 million of net sales of LOQTORZI which began shipping to distributors in December 2023 in preparation for launch."

Sales • Age-related Macular Degeneration • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ophthalmology • Ulcerative Colitis • Wet Age-related Macular Degeneration

In a boss-level move, the @CrohnsColitisFn partnered with @costplusdrugs to make biosimilar adalimumab (Yusimry) available at $584 for 2 pens.

Demonstration of Physicochemical and Functional Similarity of Biosimilar Adalimumab-aqvh to Adalimumab. (PubMed, Drugs R D) - "The structural, functional, and stability data provide convincing evidence of biosimilarity between adalimumab-aqvh and the reference product, adalimumab."

Journal

Senderra Specialty Pharmacy announces that HUMIRA biosimilar products are now available to patients nationwide (PRNewswire) - "Senderra Specialty Pharmacy announced today that patients can access several HUMIRA biosimilar medications through Senderra's pharmaceutical manufacturing partnerships. This development allows patients to access biosimilars nationwide through Senderra Specialty Pharmacy conveniently. The HUMIRA biosimilar products offered by the following pharmaceutical manufacturers are now accessible to our patients: Amgen is offering AMJEVITA, (adalimumab), a biosimilar of HUMIRA; Coherus is offering YUSIMRY (adalimumab), a biosimilar of HUMIRA; Fresenius Kabi is offering IDACIO, (adalimumab), a biosimilar of HUMIRA; Organon is offering HADLIMA, (adalimumab), a biosimilar of HUMIRA; Sandoz is offering HYRIMOZ, (adalimumab), a biosimilar of HUMIRA."

Reimbursement • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ophthalmology • Psoriasis • Ulcerative Colitis

Coherus and Superior Biologics Announce National Distribution Agreement for YUSIMRY (GlobeNewswire) - "Coherus BioSciences, Inc...and specialty pharmacy Superior Biologics, Inc...today announced a national distribution agreement for YUSIMRY™ (adalimumab-aqvh) at a price of $995 per carton of two autoinjectors, a discount of more than 85% compared to Humira® (adalimumab), currently priced at $6,922 per carton of two pens."

Licensing / partnership • Pricing • Ankylosing Spondylitis • Crohn's disease • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Coherus Launches YUSIMRY, a Biosimilar of Humira, at $995 per Carton in U.S. (GlobeNewswire) - "Coherus BioSciences, Inc...today announced that YUSIMRY™ (adalimumab-aqvh) is now available for commercial sale in the United States at a list price of $995 per carton for two 40 mg/0.8 mL autoinjectors, representing a discount of more than 85% to Humira® (adalimumab), currently priced at $6,922 per carton of two pens...YUSIMRY is presented in a state-of-the-art autoinjector and includes Coherus’ proprietary non-stinging, citrate-free formulation and a 29-gauge needle."

Biosimilar launch • Pricing • Ankylosing Spondylitis • Crohn's disease • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

SmithRx will be First PBM to Offer YUSIMRY, a Humira Biosimilar, for One-Tenth the List Price of Humira (GlobeNewswire) - "SmithRx...announced today that it will offer YUSIMRY, a biosimilar of Humira, to its members for more than 90 percent less than the list price of Humira. Working with Mark Cuban Cost Plus Drug Company, PBC, SmithRx will cover YUSIMRY when it is launched in early July 2023. YUSIMRY will be available through the Cost Plus Drugs online mail-order pharmacy for $569.27 plus dispensing and shipping fees, compared to the current price of Humira of $6,922 per carton. Unique to this collaboration, SmithRx members will be able to apply their insurance benefits to further reduce their out-of-pocket costs for YUSIMRY."

Reimbursement • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Mark Cuban Cost Plus Drug Company joins forces with Coherus to make YUSIMRY, a HUMIRA biosimilar, available to patients (GlobeNewswire) - "Mark Cuban Cost Plus Drug Company, PBC...and Coherus BioSciences, Inc...announced plans to offer Mark Cuban Cost Plus Drug Company customers YUSIMRY (adalimumab-aqvh), a biosimilar of HUMIRA® (adalimumab injection), in July 2023...Mark Cuban Cost Plus Drug Company plans to offer YUSIMRY to its customers at a price of $569.27 plus dispensing and shipping fees starting in July 2023."

Licensing / partnership • Immunology

Coherus Announces Industry-Wide Lowest List Price for Adalimumab Biosimilar YUSIMRY (adalimumab-aqvh) Launching in July 2023 (GlobeNewswire) - "Coherus BioSciences, Inc...announced that the company plans to launch YUSIMRY™ (adalimumab-aqvh) in July 2023 with a list price of $995 per carton (2 x 40 mg/0.8 mL autoinjectors), the lowest price announced to date of any adalimumab offering in the United States. With Humira® currently priced at $6,922 per carton of two autoinjectors, the YUSIMRY price will represent about an 85% discount from the originator....No sales will occur, and no purchase orders will be accepted, until July 2023."

Launch US • Pricing • Ankylosing Spondylitis • Crohn's disease • Hidradenitis Suppurativa • Inflammation • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

"What are🌼 Amjevita,🌼 Hadlima, 🌼Cyltezo, 🌼Yusimry,🌼 Hulio, 🌼Hyrimoz, and 🌼 Abrilada" (@ibdtweets)

Efficacy and Safety Similarity of Biosimilar Adalimumab-aqvh to Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Phase III Study (ACR Convergence 2022) - P3 | "There were no clinically meaningful differences in efficacy, safety, immunogenicity, or pharmacokinetics between adalimumab-aqvh and adalimumab in patients with psoriasis. All endpoints demonstrated similarity between adalimumab-aqvh and adalimumab"

Clinical • P3 data • Dermatology • Immunology • Inflammation • Psoriasis

Pharmacokinetic Equivalence of Biosimilar Adalimumab-aqvh and Adalimumab in Healthy Subjects (ACG 2022) - "The C max geometric mean ratio (GMR) was 98.6% (90% CI 90.7–107.3) and the AUC 0-inf GMR was 102.7% (90% CI 92.2–114.3); PK bioequivalence was demonstrated, as both endpoints were contained within the predefined 90% CI GMR range (80%–125%). The other PK endpoints were similar between adalimumab-aqvh and adalimumab. Treatment-emergent adverse events (TEAEs) and study drug–related TEAEs were similar for each treatment, and most were mild or moderate in severity; no new safety signals were identified."

Clinical • PK/PD data • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

FDA Approves Coherus’ CIMERLI (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis for All Five Indications, with 12 Months of Interchangeability Exclusivity (GlobeNewswire) - "'Our upcoming launch of CIMERLI™ and planned launch next year of our third approved product, our Humira® biosimilar, YUSIMRY™, will leverage this experience and knowledge.'....Commercial availability of CIMERLI™, in both 0.3 mg and 0.5 mg dosages, is planned for early October 2022. Retina indications for which CIMERLI™ is interchangeable include Neovascular (wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Myopic Choroidal Neovascularization (mCNV)."

Biosimilar launch • Commercial • Age-related Macular Degeneration • Immunology • Inflammation • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Coherus BioSciences Reports Fourth Quarter and Full Year 2021 Results (GlobeNewswire) - "The increase of $220.3 million was primarily due to the $136.0 million upfront license fee paid to Junshi Biosciences and also due to costs incurred in the development of YUSIMRY...which Coherus is planning to launch in 2023."

Biosimilar launch • Commercial • Immunology • Inflammatory Bowel Disease

Coherus Announces U.S. FDA Approval of YUSIMRY (adalimumab-aqvh) (GlobeNewswire) - "Coherus BioSciences, Inc...announced that the United States Food and Drug Administration ('FDA') approved YUSIMRY™ (adalimumab-aqvh), formerly CHS-1420, a Humira® (adalimumab) biosimilar product. YUSIMRY is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis...Approval was based on a comprehensive data package that demonstrated the biosimilarity of YUSIMRY to the reference product, Humira...Coherus plans to launch YUSIMRY in the U.S. on or after July 1, 2023, per the terms of an agreement with Humira® manufacturer, AbbVie."

sBLA • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Coherus BioSciences Reports Third Quarter 2021 Results (GlobeNewswire) - "Excluding the upfront payment made to Junshi Biosciences in the first quarter, Coherus projects full year 2021 R&D and SG&A expenses in a range of $370 million to $400 million. R&D spending is focused on development, regulatory and other activities in preparation for the potential launch of toripalimab, as well as manufacturing-related and regulatory activities for CHS-1420 (Humira® biosimilar)..."

Commercial • Immunology • Inflammatory Bowel Disease

Coherus BLA Filing for Adalimumab Biosimilar Candidate Accepted by FDA for Review (GlobeNewswire) - "Coherus BioSciences, Inc...announced that the United States Food and Drug Administration ('FDA') has accepted for review the 351(k) Biologics License Application ('BLA') for CHS-1420...and has set a Biosimilar User Fee Act action date for December 2021. If approved, Coherus plans to launch the adalimumab biosimilar in the U.S. on or after July 1, 2023, per the terms of an agreement with Humira® manufacturer AbbVie."

Biosimilar launch • BLA • BsUFA date • Immunology • Inflammatory Bowel Disease

"$CHRS Coherus BLA Filing for Adalimumab Biosimilar Candidate Accepted by FDA for Review https://t.co/lsoS90VZDc" (@stock_titan)

Review

PsOsim: Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis (clinicaltrials.gov) - P3; N=545; Completed; Sponsor: Coherus Biosciences, Inc.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Immunology • Psoriasis

Coherus BioSciences reports corporate highlights and second quarter 2018 financial results [CHS-1420] (Nasdaq) - "Guidance for 2018: CHS-1420 (adalimumab (Humira®) biosimilar): Pursue manufacturing objectives in support of a BLA."

BLA

CHS-1420: Anticipated 351(k) BLA submission in Q2 2017 (Coherus) - Q4 & FY 2016 Financial Results

BLA • Biosimilar