Udenyca (pegfilgrastim-cbqv) / Coherus Biosci, Intas - LARVOL DELTA

Accord BioPharma, Inc. Announces Completion of UDENYCA (pegfilgrastim-cbqv) Franchise Acquisition from Coherus BioSciences, Inc., Expanding U.S. Biosimilar Portfolio (PRNewswire) - "Accord BioPharma, Inc...announced today that Intas Pharmaceuticals has completed its acquisition of the UDENYCA (pegfilgrastim-cbqv) business from Coherus BioSciences, Inc...By acquiring UDENYCA, Accord BioPharma will continue to make this treatment available to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs....The acquisition not only expands Accord BioPharma's product offerings, but also brings a wealth of talent from Coherus BioSciences. Key Coherus employees across multiple functions, including Sales, Marketing, Finance, Supply Chain, and Quality and Manufacturing, will join Accord BioPharma, playing a crucial role in supply and services continuity/transition and expanding the company's work around UDENYCA."

Commercial • Chemotherapy-Induced Neutropenia • Febrile Neutropenia

Coherus Completes Strategic Transformation with Successful Divestiture of UDENYCA Franchise (GlobeNewswire) - "Coherus BioSciences, Inc...announced the completion of the previously announced divestiture of its UDENYCA (pegfilgrastim-cbqv) franchise (the Transaction) to Intas Pharmaceuticals Ltd. (Intas) pursuant to the asset purchase agreement (the Agreement) dated December 2, 2024 between Coherus and Intas in a deal valued at up to $558.4 million. Coherus received an upfront payment of $483.4 million, including $118.4 million for UDENYCA inventory, and is eligible to receive potential milestone payments of up to $75 million....At the closing of the Transaction, which occurred on April 11, 2025, Coherus received an upfront cash payment of $483.4 million, subject to certain adjustments that will be finalized following the closing pursuant to the Agreement."

Commercial • Chemotherapy-Induced Neutropenia

Coherus BioSciences Reports Fourth Quarter, Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "UDENYCA net product sales for Q4 2024 were $46.3 million, an increase of 28% compared to $36.2 million for Q4 2023, despite the temporary supply interruption. UDENYCA net product sales for FY 2024 were $206.0 million, an increase of 62% compared to $127.1 million for FY 2023. Production of UDENYCA by the Company’s third-party labeling and packaging contract manufacturing organization (CMO) resumed in November 2024. An additional final packaging and labeling CMO is expected to deliver saleable product in late Q1 or in early Q2 2025, subject to U.S. Food and Drug Administration (FDA) authorization. In December 2024, Coherus announced the divestiture of the UDENYCA franchise for up to $558.4 million. The transaction is subject to shareholder approval and other closing conditions and is expected to close late in the first quarter or early in the second quarter of 2025."

Commercial • Chemotherapy-Induced Neutropenia

Coherus Announces Agreement to Divest UDENYCA Franchise for up to $558 million to Intas Pharmaceuticals Ltd. (GlobeNewswire) - "Coherus BioSciences, Inc...announced that it has entered into an asset purchase agreement (the Agreement) dated December 2, 2024, with Intas Pharmaceuticals Ltd. (Intas) for the divestiture of the UDENYCA (pegfilgrastim-cbqv) franchise for up to $558.4 million....Coherus to focus exclusively on innovative immuno-oncology programs that include LOQTORZI, an FDA approved, next-generation programmed cell death protein 1 (PD-1) inhibitor; Proceeds to fund development of key combination programs with LOQTORZI, including casdozokitug, a first-in-class, clinical-stage interleukin-27 (IL-27) antagonist, and CHS-114, a highly selective chemokine receptor 8 (CCR8) antibody."

Commercial • Clear Cell Renal Cell Carcinoma • Hepatocellular Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer

Patterns of Medicare Utilization and Spending on Granulocyte Colony-Stimulating Factors: Filgrastim, Pegfilgrastim, and Their Biosimilars (ASH 2024) - "Data for Neupogen and its biosimilars (Zarxio, Nivestym, Granix) and Neulasta and its biosimilars (Fulphila, Udenyca, Ziextenzo and Nyvepria) was extracted. Neulasta maintains the lowest average spending per beneficiary, highlighting its ongoing value proposition despite the increasing role of biosimilars in the treatment landscape. In conclusion, by leveraging the market competition from biosimilars, the healthcare system can achieve a more balanced approach to delivering high-quality care while managing costs effectively."

Medicare • Reimbursement • US reimbursement • Hematological Disorders

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

Demonstration of Physicochemical and Functional Similarity of Biosimilar Pegfilgrastim-cbqv to Pegfilgrastim. (PubMed, Drugs R D) - "The structural, functional, and stability data demonstrate that pegfilgrastim-cbqv is highly similar to the reference product, pegfilgrastim."

Journal • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Neutropenia • Oncology

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 Announces Full Repayment of Pharmakon Advisors $75 Million Term Loan (GlobeNewswire) - "Coherus BioSciences, Inc...announced it entered into a combined term loan and product royalty financing agreement with Barings that has allowed Coherus to fully pay off the remaining $75 million of its Pharmakon Advisors term loan. This further reduces the Company’s term loan debt by approximately half, with an extended loan maturity date of May 2029...'This debt and royalty financing arrangement fully repays the $75 million remaining on our prior $250 million term loan that was due in October 2025.'...Under the terms of the royalty monetization facility, Coherus received $37.5 million in return for a certain net sales royalty percentage consideration on U.S. sales of LOQTORZI and UDENYCA up to a hard cap. Under the term loan, Coherus received $38.7 million in proceeds from a structured debt loan with a May 2029 maturity."

Licensing / partnership • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Changes in US payer biosimilar coverage policies of granulocyte colony-stimulating factor products (AMCP 2024) - "For filgrastim biosimilars, 84% of payers preferred Zarxio, whereas Neupogen, Nivestym, and Releuko were most commonly nonpreferred...For pegfilgrastim biosimilars, 62% of payers preferred Ziextenzo, 60% preferred Neulasta, and 55% preferred Fulphila, whereas Nyvepria, Fylnetra, and Stimufend were most commonly nonpreferred. Prefer- ence for Udenyca was split, with 45% of payers preferring this agent and 45% of payers listing it as nonpreferred... Payer policies for granulocyte colony stimu- lating factor biosimilars indicated that Neulasta has retained much of its preferred status, whereas Neupogen is often nonpreferred. In both cases, average time to policy addition was about 4 months after FDA approval. Further, pegfil- grastim policies had more updates to the preferred product status than filgrastim policies, possibly because of more pegfilgrastim biosimilars being approved and marketed."

Evaluation of Same-Day vs Next Day Administration of Prophylactic Pegfilgrastim in Fluoropyrimidine-Based GI Cancer Treatment (HOPA 2024) - " A multicenter, retrospective chart review of patients who received pegfilgrastim-based GCSF for an associated GI cancer treated with FOLFOX, FOLFIRI, FLOT, or FOLFIRINOX chemotherapy from December 11, 2021 to December 11, 2023 at NCI... Pending results"

Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Gastrointestinal Cancer • Gastrointestinal Disorder • Hematological Disorders • Neutropenia • Oncology

A Randomized, Open-Label Study Conducted to Evaluate the Bioequivalence of Pegfilgrastim-cbqv On-Body Injector Versus Prefilled Syringe in Healthy Male Participants. (PubMed, Adv Ther) - "Results of the study showed PK and PD bioequivalence of pegfilgrastim-cbqv administered using OBI compared with PFS. OBI and PFS administration had similar safety, tolerability, and immunogenicity profiles. No unexpected safety signals were identified. Graphical Abstract available for this article."

Journal • Dermatology • Febrile Neutropenia • Hematological Disorders • Musculoskeletal Diseases • Neutropenia

Coherus Announces FDA Approval of UDENYCA ONBODY, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv (GlobeNewswire) - "Coherus BioSciences... announced that the U.S. Food and Drug Administration (FDA) approved UDENYCA ONBODY, the company's on-body injector (OBI) presentation of UDENYCA (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia....The approval of UDENYCA ONBODY was supported by a comprehensive analytical and clinical data package, including pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence data as well as adhesive performance and tolerability data. Commercial availability of UDENYCA ONBODY is planned for the first quarter of 2024."

FDA event • Launch US • Chemotherapy-Induced Neutropenia

Pharmacokinetic and Pharmacodynamic Bioequivalence of Pegfilgrastim-cbqv Delivered via a Prefilled Autoinjector and Prefilled Syringe in Healthy Male Participants. (PubMed, Adv Ther) - "The bioequivalence of pegfilgrastim-cbqv administered using a prefilled AI and a PFS was established. The safety, including immunogenicity profiles, of pegfilgrastim-cbqv administered using the prefilled AI and the PFS were similar, with no new safety findings."

Journal • PK/PD data • Febrile Neutropenia • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Pain

Coherus Announces Resubmission of Biologics License Application (BLA) Supplement for UDENYCA ONBODY (GlobeNewswire) - "Coherus BioSciences, Inc...today announced the Company has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, the company's on-body injector presentation of UDENYCA® (pegfilgrastim-cbqv), to the U.S. Food and Drug Administration (FDA) for review...The CRL did not identify any issues with the UDENYCA® ONBODY™ clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing, and no additional data or trials have been requested....'As the CRL identified no other issues with the BLA supplement, we look forward to working closely with the agency to complete the review of the UDENYCA® ONBODY™ application in a timely manner and anticipate potential approval later this year.'"

BLA • Oncology

FDA Issues Complete Response Letter (CRL) for UDENYCA ONBODY Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-Party Filler; Coherus Also Announces Completion of Toripalimab FDA Inspections (GlobeNewswire) - "Coherus BioSciences, Inc...announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) supplement for UDENYCA^® ONBODY™, the company's on-body injector (OBI) presentation of UDENYCA^® (pegfilgrastim-cbqv), solely due to an ongoing review of inspection findings at a third-party filler....Coherus is committed to working closely with the FDA and the third-party filler to bring UDENYCA^® ONBODY™ to cancer patients requiring pegfilgrastim treatment as quickly as possible."

FDA event • Oncology

Coherus Announces U.S. Launch of UDENYCA Autoinjector (GlobeNewswire) - "Coherus BioSciences, Inc...announced that the single-dose (6mg/0.6mL), prefilled autoinjector presentation of UDENYCA^® (pegfilgrastim-cbqv) is now available for commercial sale in the United States."

Launch US • Chemotherapy-Induced Neutropenia • Oncology

"BREAKING: @US_FDA Approves Biosimilar Pegfilgrastim-cbqv for Febrile Neutropenia #oncology #medtwitter https://t.co/Rp4KUiOMlw" (@OncLive)

FDA event • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology

FDA Approves UDENYCA Autoinjector (GlobeNewswire) - "Coherus BioSciences...today announced that the U.S. Food and Drug Administration ('FDA') approved a single-dose, prefilled autoinjector presentation of UDENYCA® (pegfilgrastim-cbqv), a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia....The approval of UDENYCA® AI was supported by a comprehensive analytical data package, as well as a pharmacokinetic, pharmacodynamic and immunogenicity study....Commercial availability of UDENYCA® AI is planned for the second quarter of 2023."

FDA event • Chemotherapy-Induced Neutropenia • Oncology

"$CHRS FDA Approves UDENYCA® Autoinjector https://t.co/E8dys9ZuTm #fdaapproval" (@stock_titan)

FDA event

Comparative effectiveness of pegfilgrastim biosimilars vs originator for prevention of febrile neutropenia: A retrospective cohort study. (PubMed, J Manag Care Spec Pharm) - "OBJECTIVE: To compare the risk of febrile neutropenia (FN) among users of pegfilgrastim biosimilars (pegfilgrastim-jmdb and pegfilgrastim-cbqv) and the originator product...These results add further to the current evidence on pegfilgrastim biosimilars and support wider adoption of pegfilgrastim biosimilars among payers, providers, and patients. Future studies assessing the tolerability, side effects, and other safety issues of pegfilgrastim biosimilars are needed."

HEOR • Journal • Retrospective data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

A population-based analysis of prophylactic G-CSF biosimilar and originator administration over time among patients diagnosed with breast cancer (SABCS 2022) - "Chemotherapy regimens included cyclophosphamide/doxorubicin (n=7,377), carboplatin/docetaxel/trastuzumab/pertuzumab (n=1,862), cyclophosphamide/docetaxel (n=1,383), carboplatin/docetaxel/trastuzumab (n=430), cyclophosphamide/docetaxel/doxorubicin (n=147), and docetaxel/trastuzumab/pertuzumab (n=128)...Eight hundred fifteen (7%) patients received intermediate-risk chemotherapy and G-CSF utilization was, 716 (88%) pegfilgrastim, 27 (3%) pegfilgrastim-cbqv, 25 (3%) pegfilgrastim-jmdb, 23 (3%) filgrastim, 16 (2%) filgrastim-sndz, 5 (< 1%) tbo-filgrastim, and 3 (< 1%) combination... The most common chemotherapy agents included cyclophosphamide, carboplatin, doxorubicin, docetaxel, or pertuzumab. Pegfilgrastim biosimilar uptake occurred following market availability. Within each G-CSF product, most patients received the same product during the second cycle of chemotherapy rather than switching products."

Clinical • Breast Cancer • Oncology • Solid Tumor • CSF3

A Retrospective Analysis of Prophylactic G-CSF Biosimilar and Originator Administrative Claims over Time Among Patients with Non-Hodgkin Lymphoma (ASH 2022) - "Of 2,094 (81%) patients who received high-risk chemotherapy, 1,919 (92%) received pegfilgrastim, 71 (3%) pegfilgrastim-cbqv, 49 (2%) pegfilgrastim-jmdb, 21 (<1%) filgrastim, 20 (<1%) filgrastim-sndz, and 14 (<1%) tbo-filgrastim or a combination of products...The most common chemotherapy regimens included cyclophosphamide/doxorubicin/vincristine/rituximab (n=1,304), bendamustine/rituximab (n=469), cyclophosphamide/rituximab (n=119), cyclophosphamide/doxorubicin/vincristine (n=105), rituximab (n=101), doxorubicin/vinblastine (n=91), and cyclophosphamide/doxorubicin/etoposide/vincristine/rituximab (n=46)...Pegfilgrastim biosimilar uptake occurred following market availability. Within each G-CSF product, most patients received the same product during the second cycle of chemotherapy rather than switching products."

Retrospective data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CSF3

Randomized, single-blind, crossover study to assess the pharmacokinetic and pharmacodynamic bioequivalence of CHS-1701 to pegfilgrastim in healthy subjects. (ASCO 2017) - P1; "This study established the bioequivalence of CHS-1701 to pegfilgrastim with respect to PK and PD. There were no unexpected safety findings, and the two treatments displayed similar safety profiles."

Biosimilar • Immunology • Pain

An exploratory comparative effectiveness analysis of febrile neutropenia incidence among patients with cancer receiving granulocyte colony stimulating factors. (ASCO-QC 2022) - " A total of 15,941 patients received a pegfilgrastim product in cycle 1 of chemotherapy: 15,115 (95%) pegfilgrastim, 484 (3%) pegfilgrastim_cbqv, 342 (2%) pegfilgrastim_jmdb. We observed no significant difference in FN incidence among patients when comparing various G-CSF products, including when biosimilars were compared to their reference counterparts."

HEOR • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • CSF3