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
Akaal Pharma Pty Ltd Announces Licensing Agreement for its First-in-Class, Topical Spingosine-1-Phosphate-1 (S1P1) Receptor Modulator for Atopic Dermatitis and Psoriasis18.12.2018 23:56 | Pressemelding
Akaal Pharma Pty Limited (Akaal Pharma) today announced that it has entered into a licensing agreement for Akaal Pharma’s First-in-Class, topical Spingosine-1-Phosphate-1 (S1P1) modulator, AKP-11, with Boston Pharmaceuticals, Inc. (Boston Pharmaceuticals). AKP-11 is a differentiated S1P1 modulator, which potentially has clinical applications in a number of inflammatory, immune and vascular diseases. Akaal Pharma has demonstrated the clinical activity of AKP-11 in multiple Phase-1 clinical studies. Under the terms of the license, Boston Pharmaceuticals is responsible for the further clinical development and commercialisation of AKP-11 for the Americas and Europe. Akaal Pharma has the rights for the rest of the world. Financial terms of the agreement were not disclosed. "We continue to actively prioritize and expand our dermatology and pain programs to serve the wider global community suffering from these diseases and where there is need of safe and effective treatment,” said Chairman of
Takeda Announces Listing of American Depositary Shares on the New York Stock Exchange18.12.2018 22:33 | Pressemelding
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today announced that the listing and trading of its American Depositary Shares (“ADSs”) on the New York Stock Exchange (“NYSE”) is expected to commence on December 24, 2018. Takeda’s ADSs currently trade over-the-counter. The ADSs will now trade under the ticker symbol “TAK” and The Bank of New York Mellon will continue to act as the depositary bank for the ADS program. Takeda will maintain its headquarters in Japan and its primary listing on the Tokyo Stock Exchange (the “TSE”), as well as its current listings on local Japanese stock exchanges. “Our dual listing on the NYSE and TSE reflects our position as a leading global biopharmaceutical company and will provide wider capital markets access with expanded trading hours for our in
Sestek Speech Analytics Scores the Highest Overall Vendor Satisfaction Mark from Customers in DMG Consulting Survey18.12.2018 19:00 | Pressemelding
Sestek today announced that it was recognized for getting the highest overall vendor satisfaction rating from customers in DMG Consulting’s 2018 – 2019 Speech Analytics Product and Market Report. Compared to the featured competitors, Sestek Speech Analytics achieved the highest customer ratings in 8 major vendor categories out of 10. Here are the 7 categories in which Sestek Speech Analytics received a perfect score of 5.0 by the customer satisfaction ratings: • Training and workshops • Ongoing service and support • Professional services • Innovation • Responsiveness to product enhancement requests • Vendor communication • Overall vendor satisfaction Donna Fluss, the President of DMG Consulting -providing comprehensive coverage and authoritative analysis for the market- stated the importance of speech analytics: “Speech analytics has always been interesting because of its unique contributions to the understanding of voice interactions in the contact center. Companies that invest in the
Brand Marketing and Social Purpose Veteran Larry Koffler Joins BCW18.12.2018 18:31 | Pressemelding
BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Larry Koffler has joined as Executive Vice President, Managing Director in the agency’s Brand Solutions Practice in New York. He will join BCW on January 14, 2019. “Larry has had an extraordinary career leading integrated communications programs that bridge brand, corporate and purpose for some of the world’s most iconic brands and organizations,” said Chris Foster, President, North America, BCW. “His award-winning experience across a wide variety of industries will be invaluable to clients – and in particular purpose-driven clients – that need powerful programs that exceed expectations and drive meaningful results. I am excited for what he will add to BCW’s celebrated brand solutions business.” Koffler will report to Thomas Bunn, Executive Vice President, Managing Director, Brand Solutions. Koffler joins BCW from Edelman, where he spent the entirety of his career and most recently served as Executi
Skitude Premium Launches, Offering Personalised 3D Mapping, 3D Tracks, Advanced Statistics, Speed Heat Maps and Apple Watch Compatibility18.12.2018 15:58 | Pressemelding
Skitude, the world’s largest apps community of digitally-connected snow sport lovers, with over a million users, has launched a premium version of its popular profile. Skitude apps are available for Android and Apple devices, and the premium upgrade offers the option to see your day’s skiing/boarding as an interactive 3D map, a speed ‘heat map’ or by statistical analysis of descents, slopes and distances covered. There is also Apple Watch compatibility, so your smartphone battery won’t be dead by lunchtime, as can often be the case with tracking apps. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181218005591/en/ (Photo: Skitude) Premium also offers 3D maps and advanced statistics for over 2,500 resorts worldwide, with real time information on slope conditions and whether runs are open. There are ‘points of interest’, webcams and a wealth of other useful information to help you make the most of your time on the slopes. Skit
PSB Names Mike Chuter Chief Executive Officer18.12.2018 14:15 | Pressemelding
PSB, a global research-based consultancy within BCW, announced today that Mike Chuter has joined the firm as Chief Executive Officer, effective immediately. Chuter is based in New York and reports to Donna Imperato, Global CEO of BCW. He is responsible for the global growth and development of the organization across its Corporate, Political, Media and Entertainment practices. “Mike is exceptionally well-suited to lead PSB given his deep experience interpreting data through both analytical and creative lenses and in driving integrated communications programs rooted in analytics,” said Imperato. “Mike is the right person to help PSB advise on holistic creative communications solutions that leverage the firm’s industry-leading expertise in primary research and behavioral, social and other third-party data analysis.” Chuter is a 25-year agency veteran who joins PSB from global social impact organization Thankful, which he co-founded in 2013, a one-half commercial enterprise, one-half socia