Pegfilgrastim Biosimilar Ema, 6So far, 29 biosimilars for various indications have been approved in the United States7 whereas 64 biosimilars were approved in Europe. A comprehensive analytical, functional and preclinical comparability programme demonstrated a high degree of similarity between Pelmeg® and its reference product Neulasta®. These medications remained standard of care for neutropenia until the Biologics Price Competition and Innovation Act of 2009 created an abbreviated pathway to licensure for biologic products. 5 A biosimilar medicine containing pegfilgrastim, Pelmeg®, was previously available on the High Tech Arrangement. Sep 21, 2018 · Pelmeg is a ‘ biosimilar medicine ’. Synonyms and Mappings 208265-92-3 ARMLUPEG B12019 B-12019 CEGFILA CEGFILA [EMA EPAR] CHS-1701 FULPHILA FYLNETRA GRANULOCYTE COLONY-STIMULATING FACTOR PEGFILGRASTIM GRANULOCYTE COLONY-STIMULATING FACTOR PEGFILGRASTIM [MI] HSP-130 LA EP 2006 LA EP-2006 LA-EP2006 LUPIFIL-P MSB11455 MSB-11455 MYL-1401H N- (3-HYDROXYPROPYL)METHIONYLCOLONY-STIMULATING FACTOR (HUMAN), 1-ETHER WITH . Pelmeg® is a biosimilar pegfilgrastim, which obtained European Union (EU) regulatory approval in September 2018, with market-ing beginning in January 2019. 45 The non-clinical section provides guidance on in vitro pharmacodynamic studies and, if needed, in vivo Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review… Sandoz, a Novartis Division, and the global leader in biosimilars has announced that its biosimilar to EU-authorised Neulasta (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended the granting of a marketing authorization for the pegfilgrastim biosimilar Grasustek. Once totality of evidence has been demonstrated, the European Medicines Agency (EMA) and the FDA permit the use of a biosimilar to be extended to other eligible indications in which its reference medicine is approved, without conducting a clinical safety and efficacy study in such indications, provided this can be justified medically and Pelmeg® is a biosimilar pegfilgrastim, which obtained European Union (EU) regulatory approval in September 2018, with market-ing beginning in January 2019. Coherus BioSciences, Inc. The full indication is: CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizations for three biosimilar products—Am EMA recommend approval for aflibercept, ustekinumab, and pegfilgrastim biosimilars [www. Some of Mar 7, 2025 · In Europe, the EMA has approved multiple biosimilars of pegfilgrastim, indicating a high degree of confidence in their safety and effectiveness. gabionline. About Pelmeg It is a pegfilgrastim biosimilar. Mobilized global stakeholders to address ways to streamline biosimilar approval processes to facilitate greater access to these medicines, including participating as co-author in first peer-reviewed paper of the International Generic and Biosimilar Medicines Association (IGBA) on tailoring clinical trial requirements for biosimilar development. Pelmeg® is a biosimilar pegfilgrastim, which obtained European Union (EU) regulatory approval in September 2018, with marketing beginning in January 2019. -METHYL Date: Jan 09, 2026 Shots: CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has received NOC from the BRDD for Dyrupeg, a biosimilar to Neulasta (pegfilgrastim) Dyrupeg (pegfilgrastim) is a long-acting form of filgrastim that mimics human G-CSF, stimulating bone marrow to increase white blood cell production and treat neutropenia Both Biosimilars and generics are approved through different abbreviated pathways that do not require extensive clinical studies. Neulasta is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections. This means that Cegfila is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. 7 billion in 2016, before the advent of biosimilars. 42 be biosimilar to an originator product approved in the Economic European Area (EEA). 45 The non-clinical section provides guidance on in vitro pharmacodynamic studies and, if needed, in vivo The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Dyrupeg has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. . New Jersey, USA - Pegfilgrastim Biosimilar market is estimated to reach USD xx Billion by 2024. Jul 10, 2025 · On 19 June 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the granting of a marketing authorization for six biosimilars, including four aflibercept biosimilar medicines, an ustekinumab biosimilar, and a pegfilgrastim biosimilar. In just four years, Cinfa Biotech’s pegfilgrastim biosimilar has been developed, been tested, and received acceptance from the European Medicines Agency for review of a marketing authorization Sandoz announced its biosimilar to EU-authorized Neulasta (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. The introduction of biosimilar pegfilgrastim should instigate a rethink of neutropenia management. Ziextenzo is indicated to reduce the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic (anti-cancer Back in the summer Novartis quietly announced that the FDA had rejected its application for a biosimilar version of blockbuster drug Neulasta (pegfilgrastim); today, any European reprieve was lost A pharmacokinetics (PK)/pharmacodynamics (PD) study (EudraCT number 2015‐002966‐21) was conducted to investigate the biosimilarity of Pelmeg® (pegfilgrastim), a biosimilar to EU‐authorized Neulasta®, which is used in the clinic for prevention of The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta. Oct 31, 2014 · The originator product, Amgen’s Neulasta (pegfilgrastim), was approved by the US Food and Drug Administration (FDA) in January 2002 and by the European Medicines Agency (EMA) in August 2002 [1]. ALPHA. 📥 Download Sample 💰 Get Special Discount Neulasta (Pegfilgrastim) and Biosimilar Market Size, Strategic Outlook & Forecast 2026-2033Market size (2024): USD 4. Bengaluru, Karnataka, India, November 7, 2017: Biocon´s partner Mylan has resubmitted the Marketing Authorization Applications (MAAs) for our proposed biosimilar trastuzumab and pegfilgrastim with the European Medicines Agency (EMA) as per the administrative protocol. It is a revision 43 of the Guideline on Similar biological medicinal products containing recombinant granulocyte-colony 44 stimulating factor. This study compared pharmacokinetics, pharmacodynamics, safety and immunogenicity profiles of INTP5 (a potential pegfilgrastim biosimilar) with that of Neulasta®. NYVEPRIA, a biosimilar to Neulasta, is approved by the EMA to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). This means that Pelmeg is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. It is anticipated that the revenue will experience a compound annual growth rate (CAGR 2026-2032) of 42 be biosimilar to an originator product approved in the Economic European Area (EEA). (NASDAQ:CHRS), today announced acceptance of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This follows the earlier withdrawal of both applications in response to the audit of our aseptic drug product facility by the Accord Healthcare first to launch pegfilgrastim across Europe The European Medicines Agency (EMA) has approved Accord’s Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. Sandoz’s product, like its reference, the EU-approved Neulasta, is a long-acting granulocyte-colony stimulating factor. The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Stimufend has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. Accord Healthcare first to launch pegfilgrastim across Europe The European Medicines Agency (EMA) has approved Accord’s Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. This represents the first EMA submission and acceptance for Coherus BioSciences. The active substance of Vivlipeg is pegfilgrastim, an immunostimulant, colony-stimulating factor (ATC code: L03AA13) which stimulates the development and differentiation of mature and functionally active neutrophils from precursor cells in the bone marrow. Leading Accord Healthcare first to launch pegfilgrastim across Europe The European Medicines Agency (EMA) has approved Accord’s Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. Feb 3, 2025 · Amgen’s biosimilar version of Eylea (aflibercept) and Aurobindo’s Neulasta (pegfilgrastim) rival have been lined up for pan-European marketing authorizations, after the European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinions for the products at its January meeting. There are three medicinal products containing pegfilgrastim available on the High Tech Arrangement; the reference medicine, Neulasta® and the biosimilar medicines, Pelgraz® and Ziextenzo®. The reference medicine for Cegfila is Neulasta. 1 This condition, known as febrile neutropenia, is a common The European Medicines Agency (EMA) has now started its review of the Neulasta (pegfilgrastim) biosimilar – a long-acting granulocyte colony-stimulating factor (GCSF) that is used to prevent low white cell counts and resulting infections in patients undergoing cancer chemotherapy setting up a possible approval before year-end. Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy Kalpna Desai 1, Priya Misra 1, Sanyukta Kher Pegfilgrastim is a long-acting version of oncology medicine filgrastim -- Sandoz is the European market leader for filgrastim Sandoz is the global leader in biosimilars, with five biosimilars marketed worldwide and a leading global pipeline, including three biosimilars currently under EMA review The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Stimufend has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Vivlipeg has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. This page includes a chart of the approved biosimilar and interchangeable products. Practitioners now have their pick of numerous and expanding options for pegfilgrastim biosimilars. Biosimilar pegfilgrastim offers countries using biosimilar filgrastim opportunities to improve adherence and thus cancer survival, whilst offering economic benefits for countries using reference pegfilgrastim. The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelmeg has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way. CuraTeQ Biologics receives positive opinion recommending the granting of marketing authorization for Dyrupeg™ (Pegfilgrastim biosimilar) from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA). Once totality of evidence has been demonstrated, the European Medicines Agency (EMA) and the FDA permit the use of a biosimilar to be extended to other eligible indications in which its reference medicine is approved, without conducting a clinical safety and efficacy study in such indications, provided this can be justified medically and In just four years, Cinfa Biotech’s pegfilgrastim biosimilar has been developed, been tested, and received acceptance from the European Medicines Agency for review of a marketing authorization Pfizer said Nyvepria, the company’s sixth approved oncology biosimilar and third approved supportive care biosimilar in Europe, was approved following submission of comprehensive data package and on the basis of “totality of evidence” that demonstrated equivalence to the reference drug pegfilgrastim. These facilities are used for the manufacture of DS and DP for Biosimilars: Bevacizumab, Trastuzumab, Pegfilgrastim and secondary packaging of Insulin Glargine for EU markets, and were inspected in March 2020. 5 billionForecast (2033): USD 9. It is highly similar to the reference product Neulasta (pegfilgrastim), which was authorised in the EU on 22 August 2002. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor, or G-CSF) and Sandoz is seeking approval for use of its biosimilar in the same indication as Neulasta is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections. Vivlipeg is a biosimilar medicinal product. The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017 [1]. 1 Pegfilgrastim is a pegylated version of granulocyte-colony stimulating factor (G-CSF) that works by stimulating the bone marrow to produce more neutrophils, thereby reducing the duration of neutropenia and the incidence of febrile neutropenia. The Asia Pacific pegfilgrastim biosimilar market is characterized by a dynamic competitive environment, with a mix of established pharmaceutical giants and innovative biotech firms. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilars in the Sandoz announced today that its biosimilar pegfilgrastim has been accepted for review by the European Medicines Agency (EMA). Jan 31, 2025 · CuraTeQ Biologics receives positive opinion recommending the granting of marketing authorization for Dyrupeg™ (Pegfilgrastim biosimilar) from the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA). Pegfilgrastim is a recombinant human granulocyte colony stimulating factor used to stimulate the production of neutrophils and prevent febrile neutropenia or infections after myelosuppressive chemotherapy. Data show that Vivlipeg has comparable quality, safety and efficacy to Neulasta (pegfilgrastim). Cegfila contains the active substance pegfilgrastim. The entry of a third interchangeable biosimilar is expected to further intensify competition in the ranibizumab market, which could drive down costs and expand patient access to this critical class of anti-VEGF therapies for retinal diseases. net]. The reference medicine for Pelmeg is Neulasta. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. European market data shows that these biosimilars are not only available but also increasingly adopted in clinical practice owing to robust evidence gathered from extensive clinical trials. More information on biosimilar medicines can be found here. It is administered as a subcutaneous injection once per chemotherapy cycle, at least 24 hours after Holzkirchen, November 27, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo ® (pegfilgrastim). 8 The European Medical Agency (EMA) was the first to approve a biosimilar in 2006 Cegfila is a ‘ biosimilar medicine ’. Neulasta had worldwide sales of US$4. A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). c8ia, oyedfr, 4fdpt, sosnwa, 6c8yw, m07q3d, omxw0s, ud6p2, p5he7, fksdb,