Nyvepria (pegfilgrastim-apgf) / Pfizer - LARVOL DELTA

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

Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis. (PubMed, Expert Opin Biol Ther) - "Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment. Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%). The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval."

Journal

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."

Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe (clinicaltrials.gov) - P1 | N=141 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion

Biosimilars May Reduce Disparities in Febrile Neutropenia Treatment (Oncology Nursing News) - "'We [now] have several biosimilars available in the US and around the world, [with the reference agents] filgrastim and pegfilgrastim' said Crawford, in a presentation on new and emerging agents on outcomes of febrile neutropenia during the 2022 Supportive Care in Cancer Annual Meeting.'The potential impact of this is significant; [it represents] greater patient access, greater competition between the companies, and fostered innovation.'"

Media quote

Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe (clinicaltrials.gov) - P1 | N=141 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed

Pegfilgrastim-apgf (Nyvepria): Biosimilar USFDA approval for the treatment of chemotherapy-induced febrile neutropenia and current updates on clinical trials. (PubMed, Curr Drug Targets) - "It is the fourth FDA-approved drug for the treatment of infection exhibiting febrile neutropenia. This review abridges the indicators in the development of nyvepria foremost to approval for the treatment of febrile neutropenia (FN), a biosimilar regulatory framework and current updates on the clinical trials (CTs)."

FDA event • Journal • Chemotherapy-Induced Neutropenia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Neutropenia • Oncology

Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe (clinicaltrials.gov) - P1 | N=134 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open

Pharmacokinetic Comparability Study in Healthy Participants - PF-06881894 On-Body Injector Relative to Prefilled Syringe (clinicaltrials.gov) - P1; N=134; Not yet recruiting; Sponsor: Pfizer

Clinical • New P1 trial

Phase I/II study to assess the clinical pharmacology and safety of single ascending and multiple subcutaneous doses of PF-06881894 in women with non-distantly metastatic breast cancer. (PubMed, Cancer Chemother Pharmacol) - P2 | "PF-06881894 as a single 3- or 6-mg dose prior to definitive surgery, or multiple 6-mg/cycle doses postoperatively, with/without myelosuppressive chemotherapy, was consistent with the clinical pharmacology and safety profile of reference pegfilgrastim."

Clinical • Journal • P1/2 data • Breast Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • CD34

FDA’s naming rule for biosimilars has undermined Congress and health care (STAT) - "I recently tried to order white blood cell growth factor (pegfilgrastim) biosimilar for one of my patients. This is a drug that helps prevent fever and infection associated with low white blood cell counts. For years, prescribing it has been simple, since the only option was the brand-name drug, Neulasta brand pegfilgrastim....Nevertheless, the FDA now requires all biologics to bear a four-letter suffix in addition to the generic name which would identify it to regulators. There are no data comparing one biosimilar to another, so physicians and pharmacists must assume it works as well as the others....Is it any wonder the advent of biosimilars has not resulted in the anticipated savings to the health care system? This week I was able to finally get pegfilgrastim-cbqv (Udenyca) approved for my patient and covered by the patient’s insurance, but only after multiple phone calls with the insurer. Now I can only hope it will be delivered in time."

Online posting

Canada approves pegfilgrastim biosimilar Nyvepria (GaBI) - "Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nyvepria (PF-06881894). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients."

Non-US regulatory • Neutropenia

Amgen v. Hospira Pegfilgrastim Case Stayed Pending Potential Summary Judgment Practice (JD Supra) - "...District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim). In the Order, the Court construed the term 'between about 0.1 M and about 1.0' to have 'its plain and ordinary meaning (that is, ‘between approximately 0.1 M and approximately 1.0 M’) and is not a functional limitation.'...The Court further ordered that the parties shall jointly submit a status update by July 12, 2021."

Corporate lawsuit • Neutropenia

Biosimilar pegfilgrastim may offer affordable treatment options for patients in France: A budget impact analysis on the basis of clinical trial and real-world data. (PubMed, J Med Econ) - "Using data from clinical trials, NYVEPRIA resulted in total annual cost savings of €14,366, €1,447,496, €1,447,496, €1,356,836, and €1,598,253 over years 1 to 5, respectively, leading to a cumulative 5-year cost savings of €5,864,448. The introduction of a new pegfilgrastim biosimilar (NYVEPRIA®) is potentially associated with substantial cost savings for French healthcare system."

Clinical • HEOR • Journal • Real-world evidence • Hematological Disorders • Neutropenia • Oncology

Pfizer’s Pegfilgrastim Biosimilar ‘Has Launched’ In The US (Generics Bulletin - Informa) - "Pfizer has pressed on with the launch of a fourth biosimilar pegfilgrastim product, Nyvepria (pegfilgrastim-apgf), according to an investment bank. With Amgen continuing to hold more than 70% of the market, there is opportunity for Pfizer to capture significant market share."

Biosimilar launch • Neutropenia

[VIRTUAL] Clinical differences in patient outcomes after use of Pegfilgrastim, Pegfilgrastim-cbqv, or Pegfilgrastim-jmdb (ASHP 2020) - "Pegfilgrastim (reference product) and the available biosimilars, pegfilgrastim-cbqv, pegfilgrastim-jmdb, pegfilgrastim-apgf, and pegfilgrastim-bmez, share an indication: to decrease incidence of FN in patients with non-myeloid malignancies receiving myelosuppressive therapy... No difference in FN incidence was determined between innovator and biosimilar products. However, this conclusion is limited by the small number of participants receiving biosimilar products. The reason for this limited biosimilar uptake is the different administration mechanisms between products; biosimilars are all administered SC whereas the innovator product can be administered SC or via wearable auto-injector."

Clinical • Hematological Disorders • Musculoskeletal Pain • Neutropenia • Oncology • Pain

Pfizer Confirms EU Pegfilgrastim Launch Plans (Generics Bulletin - Informa) - "Pfizer has revealed launch plans for its Nyvepria pegfilgrastim biosimilar, shortly after receiving formal European Commission approval."

Biosimilar launch • Neutropenia

European Commission Approves Pfizer's Pegfilgrastim Biosimilar (Center for Biosimilars) - "The European Commission (EC) has approved a Pfizer biosimilar for pegfilgrastim (Nyvepria), paving the way for marketing to begin. The drug is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients who have received chemotherapy treatment. The company said marketing is expected to begin in the first quarter of 2021."

Biosimilar launch • European regulatory • Neutropenia

FDA Approves Oncology Supportive Care Biosimilar (Pharmacy Times) - "'Chemotherapy-induced febrile neutropenia is a relatively common and severe side effect of some cancer treatments that could cause significant complications and can result in the alteration of treatment regimens,' said Ali McBride, PharmD, MS, BCPS, BCOP...in a press release. 'The FDA approval of Nyvepria provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.'"

Media quote • Regulatory

CHMP backs seven new meds in September meeting (PharmaTimes) - "Pfizer’s biosimilar to Amgen’s Neulasta (pegfilgrastim) Nyvepria (pegfilgrastim-apgf) also received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy."

European regulatory • Neutropenia • Oncology

European advisory group back Pfizer's Neulasta biosimilar (SeekingAlpha) - "The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Pfizer's (NYSE:PFE) Nyvepria (pegfilgrastim), a biosimilar to Amgen's (NASDAQ:AMGN) Neulasta."

European regulatory • Breast Cancer • Neutropenia • Oncology

FDA approves Pfizer’s oncology supportive care biosimilar, Nyvepria (pegfilgrastim-apgf) (Businesswire) - "Pfizer...announced the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA™ (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim). NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia."

BLA • Neutropenia

PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. (PubMed, Adv Ther) - P1 | "Single-dose PF-06881894 demonstrated PD/PK equivalence and comparable safety with US- and EU-pegfilgrastim reference products. Multiple-dose PF-06881894 demonstrated immunogenicity non-inferiority to pegfilgrastim-US with comparable safety. Both studies contributed to the totality of evidence supporting biosimilarity."

Clinical • Journal • PK/PD data • Hematological Disorders

BIOSIMILAR FILGRASTIM VERSUS ORIGINATOR G-CSFS FOR CD34+ CELLS MOBILIZATION AND AUTOGRAFTING IN HEMATOLOGICAL MALIGNANCIES (EBMT 2017) - "Introduction: Since 2010, Biosimilar Filgrastim (Nivestim™, Pfizer Inc.) (BioG-CSF) has been introduced into clinical practice to mobilize CD34+ cells and to reduce the duration of chemo-induced neutropenia...All but one patient also underwent chemotherapy for mobilization (cyclophosphamide ≥3g/sqm in 154/187, 82%)...All patients were prepared for the autograft with a high-dose conditioning (Melphalan 200mg/sqm in 171/220 auto-HSCTs)...Conclusion In this sizable study, BioG-CSF was as effective as Originator G-CSFs in mobilizing CD34+ cells as well as in treating post-transplant neutropenia in patients with hematological malignancies. Moreover, the extensive use of BioG-CSF led to a significant cost containment."

Clinical • Biosimilar • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Venous Thromboembolism

Pfizer moves to dismiss Amgen’s suit over proposed Neulasta biosimilar (JD Supra) - "...Pfizer filed a motion to dismiss Amgen’s complaint under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim."

Corporate lawsuit