European Commission Approves Pelmeg▼® (pegfilgrastim) as a Biosimilar Treatment to Reduce the Duration of Neutropenia and Incidence of Febrile Neutropenia in Adults Treated with Chemotherapy
The Mundipharma network of independent associated companies today announced that the European Commission (EC) has granted approval for the use of Pelmeg (pegfilgrastim) as a treatment for reduction in 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 leukaemia and myelodysplastic syndromes).1
The EC’s decision follows a recommendation from the Committee for Medicinal Products for Human Use (CHMP) that was based on a robust regulatory submission of key biosimilarity data from analytical, biofunctional and clinical study comparisons for Pelmeg.2 In all cases it demonstrated comparable pharmacodynamics, pharmacokinetics, and immunogenicity to its reference product Neulasta.3,4,5 The information submitted, and conclusions reached, were comprehensive enough to extrapolate the indication for Neulasta across to Pelmeg.2 As such, it is indicated in the exact same way as subcutaneous (pre-filled syringe) Neulasta.
“We hope this approval will significantly improve the lives of people who are affected by chemotherapy induced neutropenia and febrile neutropenia. The availability of this biosimilar represents an important opportunity to reduce healthcare costs while increasing access to an effective treatment option,” said Philippe Bastide, Head of Biosimilars, Mundipharma International.
Pelmeg is the fourth biosimilar medicine to be commercialised by the Mundipharma network. It was developed by Cinfa Biotech which was acquired by the Mundipharma network and announced in October 2018. The acquisition of Cinfa Biotech provides Mundipharma with global reach and expanded development capabilities.
▼ This medicinal product is subject to additional monitoring.
Notes to editors
About the clinical data
A comprehensive analytical, biofunctional, preclinical and clinical comparability programme has demonstrated a high degree of similarity between Pelmeg and Neulasta. Its biosimilarity has been studied in healthy volunteers who have no comorbidities, require no co-medication and are immunocompetent.3,4,5
The Pelmeg data:
- Confirmed biosimilarity to Neulasta in sensitive clinical study settings
- Demonstrated pharmacokinetic comparability to Neulasta at the clinical dose of 6 mg
- Demonstrated pharmacodynamic comparability to Neulasta at the clinical dose of 6 mg and at the reduced dose of 3 mg
- Did not show any clinically meaningful differences in the safety and immunogenicity profile compared to Neulasta
About Pelmeg ®
Pelmeg is a pegfilgrastim biosimilar.6 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 incidence of febrile neutropenia. It is administered as a subcutaneous injection once per chemotherapy cycle, at least 24 hours after cytotoxic chemotherapy.6
About neutropenia and febrile neutropenia
People taking chemotherapy for cancer are at risk of dangerously low levels of a type of white blood cell called a neutrophil. Neutrophils play an important role in the immune system guarding against infection. Febrile neutropenia is a low level of neutrophils in the blood accompanied by a fever.7
About the Mundipharma network
The Mundipharma network of independent associated companies has distribution and marketing rights from Celltrion Healthcare for three prior biosimilars – Remsima ® , Truxima ® and Herzuma ® – in Germany, Luxembourg, Ireland (Truxima ® and Herzuma ® only), Italy, UK, Netherlands and Belgium.
The Mundipharma global network of privately-owned independent associated companies was founded in 1956 by doctors and now operates in over 120 countries worldwide. We are focused on developing business partnerships to identify and accelerate meaningful technology across an increasingly diverse portfolio of therapy areas including respiratory, oncology, pain, and biosimilars. Consistent with our entrepreneurial heritage, we like to think we see what others don’t by challenging conventional wisdom and asking different and challenging questions. By working in partnership with all our stakeholders, the Mundipharma network develops medicines that create value for patients, payers and wider healthcare systems.
Neulasta® is a registered trademark of Amgen, Inc.
Pelmeg® is a registered trademark of Cinfa Biotech, S.L.
Herzuma ® , Truxima ® and Remsima® are all registered trademarks of Celltrion Inc.
1 EMA decision. Available online at: http://ec.europa.eu/health/documents/community-register/html/register.htm.
Last accessed November 2018
2 European Medicines Agency. Pelmeg® (pegfilgrastim) Summary of opinion (initial authorisation). September 2018. Available at: https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-pelmeg_en.pdf . Last accessed November 2018
3 Roth K et al. Demonstration of pharmacokinetic and pharmacodynamic comparability in healthy volunteers for B12019, a proposed pegfilgrastim biosimilar. Abstract 241. Presented at the European Cancer Congress (ECCO), 27–30 January 2017, Amsterdam, The Netherlands.
4 Roth K et al. Comparability of pharmacodynamics and immunogenicity of B12019, a proposed pegfilgrastim biosimilar to Neulasta®. Abstract 1002. Presented at the 59th American Society of Hematology (ASH) Annual Meeting, 9–12 December 2017, Atlanta, USA.
5 Roth K et al. Pharmacokinetic and pharmacodynamic comparability of B12019, a proposed pegfilgrastim biosimilar. Poster 1573. Presented at the European Society for Medical Oncology (ESMO), 8–12 September 2017, Madrid, Spain.
6 EMA website. SmPC Neulasta. Available online at: https://www.ema.europa.eu/documents/product-information/neulasta-epar-product-information_en.pdf. Last accessed November 2018
7 Patel K & West H. JAMA Oncol. 2017;3(12):1751. doi:10.1001/jamaoncol.2017.1114
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
SFL: strong financial position and results in 2018, consolidating the Group’s position as a prime player15.2.2019 18:01:00 | Pressemelding
Regulatory News: The financial statements for the year ended 31 December 2018 were approved by the Board of Directors of Société Foncière Lyonnaise (Paris:FLY) on 15 February 2019 at a meeting chaired by Juan José Brugera. 2018 business indicators were very robust, with further underlying growth in rental income and historically high EPRA earnings. The portfolio's appraisal value and the Company's net asset value also continued to grow, attesting to SFL’s excellent positioning. The auditors have completed their audit of the annual financial information and are in the process of issuing their report. Consolidated data (€ millions) 2018 2017 Change Rental income 193.5 195.8 -1.2% Adjusted operating profit* 162.1 164.1 -1.2% Attributable net profit 351.6 685.3 - EPRA earnings 106.7 102.4 +4.1% * Operating profit before disposal gains and losses and fair value adjustments 31/12/2018 31/12/2017 Change Attributable equity 4,010 3,763 +6.6% Consolidated portfolio value excluding transfer cost
5 Happening Cultural Destinations to Visit in 201915.2.2019 10:11:00 | Pressemelding
Hong Kong There’s never really a sleepy year to visit Hong Kong, but 2019 is particularly ripe for visitors. Spearheaded by the dynamic entrepreneur Adrian Cheng of K11 and New World Development, the rejuvenation of Tsim Sha Tsui harbourfront is just the starting point. The city’s iconic harbourside walkway, Avenue of Stars, has just received a much-awaited makeover that’s the brainchild of Cheng and visually conceived by James Corner, the landscape architect responsible for the High Line in New York. It sees the addition of design-driven rest areas, kiosks featuring homegrown brands, hand prints from Asian film stars and interactive digital elements. Featuring Hong Kong’s first wave energy demonstrator that produces electricity for the Avenue, the place is turned into one of the most sustainable promenades in Hong Kong. This is just one part of Cheng and his company’s grander urban revitalisation plan, Victoria Dockside, a new art and design district which will fully open in the third
ISAE-SUPAERO Launches a New MOOC about Flight Mechanics15.2.2019 09:36:00 | Pressemelding
"ABC of Flight Mechanics: How Do Planes Fly?": a MOOC dedicated to flight mechanics. The notion of flight often defies our human terrestrial instincts. How does an airplane fly? How can a pilot maintain control? How high in the sky can an aircraft climb? How does a fighter pilot fly while spinning? This online course (available in English) will cover many topics, such as atmospheric physics and Newton's laws applied to aircraft, as well as propulsion forces and longitudinal stability the question of traction. The MOOC "ABC of Flight Mechanics" is aimed at general public with a specific level of scientific knowledge. Nevertheless, various levels of learning are available, thus it allows all students to take the course without needing to plenty understand the mathematical principles. Undergraduate students in aerospace engineering, trainees as well as novice and experienced pilots, journalists and professionals in the aeronautics domain (business, engineering, marketing, communications,
REPLY: Red Reply Wins the Oracle “Partner of the Year Autonomous” Award15.2.2019 09:30:00 | Pressemelding
Red Reply, the Reply group company that specialises in the Oracle Cloud IaaS and PaaS platform has been named as Oracle “Partner of the Year: Autonomous.” The award recognises Red Reply for its work as an Oracle Cloud Managed Service Provider Partner in developing highly innovative projects using the Oracle Autonomous Database technology. Red Reply has launched a project aimed at re-engineering the Policy Enterprise DataWarehouse of Verti Assicurazioni, company operating in the online insurance sector, using the Oracle Cloud Autonomous DataWarehouse service. The Autonomous DataWarehouse is a cloud-based database that uses machine learning to eliminate manual labour in operations such as tuning, security, backups, updates and other routine activities. This selected Oracle solution is the only one of its kind capable of addressing aspects such as security, performance and high availability of data, using automatic update and tuning mechanisms, while maximising the protection of data in l
Posiflex showcases new Interactive Self-Service Kiosks and IoT Retail Product Innovations at EuroCIS 201915.2.2019 08:00:00 | Pressemelding
The Posiflex Group — a synergy of world-leading POS, kiosk, and industrial computing technologies — will introduce its full product portfolio and latest innovations at EuroCIS, the leading trade fair for retail technology, from February 19th – 21st in Düsseldorf. With a product strategy focus on serviced IoT, the Posiflex Group will be displaying smart and connected retail solutions with fully-integrated middleware, RMS (Remote Monitoring System) and hardware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190215005008/en/ Posiflex at EuroCIS Hall 9 / C42 (Graphic: Business Wire) “I am excited to introduce the Posiflex Group portfolio to the European market,” says Hans Peter Nüdling, the newly appointed Chief Strategy Officer for the Posiflex Group. “The Posiflex Group references the collective brands of the corporation, including Posiflex, Portwell and KIOSK Information Systems (KIOSK) – all under one corporate umbrella. As
OpenGate Capital Signs Agreement to Acquire SMAC Waterproofing Business from Colas Group15.2.2019 07:00:00 | Pressemelding
OpenGate Capital, a global private equity firm, announced today that Colas Group (EPA: RE) has agreed to sell SMAC to an affiliate of OpenGate Capital. Financial terms of the agreement were not disclosed. The divestiture is expected to be complete in the next 60-90 days. SMAC is headquartered in Issy-les-Moulineaux, France, and is a global manufacturer of waterproofing and building envelope solutions with two divisions: SMAC Travaux and SMAC Industrie. After Colas Group’s acquisitions of Miller McAsphalt and Alpiq's rail subsidiaries in 2018, Colas is refocusing on its strategic activities: transport infrastructure and construction materials. The sale of SMAC will reduce Colas’ revenues by an estimated €600 million but is not expected to have a significant impact on Colas' operating income. Upon OpenGate Capital’s completion of acquiring SMAC, the business will join a global portfolio of businesses which includes other industrial companies that provide building materials and solutions.