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Biologics/ Biosimilars

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https://www.readbyqxmd.com/read/28807650/current-state-of-biosimilars-in-mexico-the-position-of-the-mexican-college-of-rheumatology-2016
#1
Daniel Xibille, Sandra Carrillo, Gabriela Huerta-Sil, Ramiro Hernández, Leonardo Limón, Guadalupe Olvera-Soto, Luis Javier Jara-Quezada, Abdieel Esquivel, Marcela Pérez-Rodríguez
The present document is a position statement of the Mexican College of Rheumatology on the use of biosimilars in rheumatic diseases. This position considers that biosimilars should be considered as interchangeable, that automatic substitution without previous notice in stable patients during follow-up is not ethical, that the approval of a biosimilar should only be given after exhaustive review of preclinical and clinical data marked by Mexican regulations, that it should be clearly stated in the nomenclature of biologic drugs which is the innovator and which is the biosimilar, that it is not correct to choose a biosimilar as treatment based only on economic reasons or extrapolate indications based only on the approval of the innovator and in the absence of safety and efficacy data for the biosimilar...
August 11, 2017: Reumatología Clinica
https://www.readbyqxmd.com/read/28797783/results-of-prospective-randomized-open-label-non-inferiority-study-of-tbo-filgrastim-granix-%C3%A2-versus-filgrastim-neupogen-%C3%A2-in-combination-with-plerixafor-for-autologous-stem-cell-mobilization-in-patients-with-multiple-myeloma-or-non-hodgkin-lymphoma
#2
Pavan Kumar Bhamidipati, Mark A Fiala, Brenda J Grossman, John F DiPersio, Keith Stokerl-Goldstein, Feng Gao, Geoffrey L Uy, Peter Westervelt, Mark A Schroeder, Amanda F Cashen, Camille N Abboud, Ravi Vij
Autologous hematopoietic stem cell transplantation (Auto- HSCT) improves survival in multiple myeloma (MM) and Non-Hodgkin lymphoma (NHL). Traditionally, filgrastim (Neupogen® - recombinant G-CSF) has been used in as a single agent or in combination with plerixafor for stem cell mobilization for auto-HSCT. In Europe, recombinant G-CSF biosimilar (Tevagrastim®) is approved for various indications similar to reference filgrastim, including stem cell mobilization for auto-HSCT; However, tbo- Filgrastim (Granix®) is registered under original biologic application and is not approved for stem cell mobilization in the USA...
August 7, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28762192/a-comprehensive-review-on-copemyl-%C3%A2
#3
REVIEW
Pietro Annovazzi, Antonio Bertolotto, Vincenzo Brescia Morra, Claudio Gasperini, Enrico Montanari, Pierluigi Navarra, Francesco Patti, Maria Pia Sormani, Angelo Ghezzi
Economic sustainability is of paramount importance in the rapidly evolving therapeutic scenario of multiple sclerosis (MS). Glatiramoids are a class of drugs whose forefather, glatiramer acetate, has been used as a disease modifying drug (DMD) in patients with MS for over 20 years. Its patent expired in 2015; new versions of such drug are nowadays available on the market, potentially contributing to lowering prices and enhancing a better allocation of economic resources. In this review, we analyze the recommendations underlying the approval of both generic drugs and biosimilars by regulatory authorities, and we provide methodological tools to contextualize the design of studies on these new classes of drugs...
July 31, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/28752242/patients-understanding-and-attitudes-towards-infliximab-and-etanercept-biosimilars-result-of-a-uk-web-based-survey
#4
Mohammed I Aladul, Raymond W Fitzpatrick, Stephen R Chapman
BACKGROUND: Infliximab and etanercept biosimilars present significant potential cost savings to the NHS. Patients need to be involved in the decision to use these medicines but there is limited published literature on their knowledge and attitudes about these biosimilars. OBJECTIVES: The aim of this study was to investigate ankylosing spondylitis and rheumatoid arthritis patients' knowledge and attitudes towards infliximab and etanercept biosimilars in the UK. METHODS: A self-administered web survey was conducted among the members of the National Rheumatoid Arthritis Society and the National Ankylosing Spondylitis Society in the UK between 2 March 2017 and 2 June 2017...
July 27, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28740623/patient-access-to-reimbursed-biological-disease-modifying-antirheumatic-drugs-in-the-european-region
#5
Zoltán Kaló, Zoltán Vokó, Andrew Östör, Emma Clifton-Brown, Radu Vasilescu, Alysia Battersby, Edward Gibson
Background & Objectives: Biological disease-modifying antirheumatic drugs (bDMARDs) for the treatment of rheumatoid arthritis (RA) are not always accessible to all patients in accordance with international guidelines, partly owing to their high direct costs against a background of restricted healthcare budgets. This study compares the size of RA patient populations with access to reimbursed bDMARDs across 37 European countries, Russia, and Turkey, according to their treatment eligibility defined by European League Against Rheumatism (EULAR) recommendations and national reimbursement criteria...
2017: Journal of Market Access & Health Policy
https://www.readbyqxmd.com/read/28733914/molecular-and-functional-analysis-of-monoclonal-antibodies-in-support-of-biologics-development
#6
REVIEW
Xin Wang, Zhiqiang An, Wenxin Luo, Ningshao Xia, Qinjian Zhao
Monoclonal antibody (mAb)-based therapeutics are playing an increasingly important role in the treatment or prevention of many important diseases such as cancers, autoimmune disorders, and infectious diseases. Multi-domain mAbs are far more complex than small molecule drugs with intrinsic heterogeneities. The critical quality attributes of a given mAb, including structure, post-translational modifications, and functions at biomolecular and cellular levels, need to be defined and profiled in details during the developmental phases of a biologics...
July 21, 2017: Protein & Cell
https://www.readbyqxmd.com/read/28727871/biosimilars-in-oncology-in-the-united-states-a-review
#7
Chadi Nabhan, Sandeep Parsad, Anthony R Mato, Bruce A Feinberg
Importance: Biosimilars are biological medicines that contain a highly similar version of the active substance of an already approved biologic reference product. The availability of biosimilars might provide an opportunity to lower health care expenditures as a result of the inherent price competition with their reference product. Understanding how biosimilar cancer drugs are regulated, approved, and paid for, as well as their impact in a value-based care environment, is essential for physicians and other stakeholders in oncology...
July 20, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28721016/a-review-of-the-literature-analyzing-benefits-and-concerns-of-infliximab-biosimilar-ct-p13-for-the-treatment-of-rheumatologic-diseases-focus-on-interchangeability
#8
REVIEW
Andrea Becciolini, Maria Gabriella Raimondo, Chiara Crotti, Elena Agape, Martina Biggioggero, Ennio Giulio Favalli
The introduction of biological agents drastically changed the treatment paradigm of inflammatory arthritides, ameliorating the natural history of the diseases but concomitantly increasing the drug costs due to the manufacturing process. On this concern, biosimilar drugs may represent a valid option for reducing this elevated cost and increasing the availability of these highly effective treatments. Recently, CT-P13, the first biosimilar of infliximab, has been approved with the same indications established for the reference product (RP), and its daily use is progressively increasing...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28719221/biosimilars-biologics-that-meet-patients-needs-and-healthcare-economics
#9
Mark McCamish, William Yoon, James McKay
Biologics have revolutionized medical care, yet uniform access to these effective medicines remains difficult due to the increasing costs of healthcare. As patent exclusivity on the early biologics wanes, regulatory and legal systems are adapting to bring competition to the field in the form of biosimilars. Biosimilars are biologics that offer the same clinical benefit in one or more of the same indications as the reference biologic drug and bring competition to the biologics space. Legislation creating a pathway resulting in the first US approvals of biosimilars has been in place since 2010, but the regulatory methodology and science of evaluating the sameness of two biologics has been in use for decades...
September 2016: American Journal of Managed Care
https://www.readbyqxmd.com/read/28718062/update-on-biosimilars-in-asia
#10
REVIEW
Wen-Chan Tsai
PURPOSE OF REVIEW: This review provides an update on the evolution of, manufacturing of, and regulations for biosimilars in Asian countries. RECENT FINDINGS: The use of biologics revolutionized the treatment of various diseases. However, the high cost of biologics remained unaffordable for most Asian patients and increases the financial burden of Asian governments. The development of biosimilars provides the best solution for this predicament. A great boom of biosimilars is developing in Asia...
August 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28715605/how-to-select-a-nanosimilar
#11
Alain Astier, Amy Barton Pai, Marco Bissig, Daan J A Crommelin, Beat Flühmann, Jean-Daniel Hecq, Josefien Knoeff, Hans-Peter Lipp, Alberto Morell-Baladrón, Stefan Mühlebach
Nanomedicines in the class of nonbiological complex drugs (NBCDs) are becoming increasingly available. Up to 23 nanomedicines have been approved, and approximately 50 are in clinical development. Meanwhile, the first nanosimilars have entered the market through the generic approval pathway, but clinical differences have been observed. Many healthcare professionals may be unaware of this issue and must be informed of these clinically relevant variances. This article provides a tool for rational decision making for the inclusion of nanomedicines into the hospital formulary, including defined criteria for evaluation of substitutability or interchangeability...
July 17, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28712941/rituximab-biosimilar-and-reference-rituximab-in-patients-with-previously-untreated-advanced-follicular-lymphoma-assist-fl-primary-results-from-a-confirmatory-phase-3-double-blind-randomised-controlled-study
#12
Wojciech Jurczak, Ilídia Moreira, Govind Babu Kanakasetty, Eduardo Munhoz, Maria Asunción Echeveste, Pratyush Giri, Nelson Castro, Juliana Pereira, Luiza Akria, Sergey Alexeev, Eugeniy Osmanov, Peijuan Zhu, Siyka Alexandrova, Angela Zubel, Olof Harlin, Jutta Amersdorffer
BACKGROUND: GP2013 is a rituximab biosimilar developed to stringent development guidelines, including non-clinical and preclinical investigations and clinical trials in rheumatoid arthritis and follicular lymphoma. We aimed to compare the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of GP2013 plus cyclophosphamide, vincristine, and prednisone (GP2013-CVP) with rituximab-CVP (R-CVP) in patients with follicular lymphoma. METHODS: In this phase 3, multinational, double-blind, randomised, controlled trial, adults (aged 18 years or older) with previously untreated, advanced stage (Ann Arbor stage III or IV) follicular lymphoma of WHO histological grades 1, 2, or 3a were randomly assigned (1:1) using interactive response technology to eight cycles of GP2013-CVP or R-CVP (combination phase), followed by monotherapy maintenance in responders for a 2-year period...
July 13, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28689708/the-growing-role-of-biologics-and-biosimilars-in-the-united-states-perspectives-from-the-apha-biologics-and-biosimilars-stakeholder-conference
#13
Judy Crespi-Lofton, Jann B Skelton
OBJECTIVES: The American Pharmacists Association (APhA) convened the Biologics and Biosimilars Stakeholder Conference on November 30, 2016, in Washington DC. The objectives of the Conference were to determine the key issues and challenges within the marketplace for biologics, follow-on biologics (FOBs), and biosimilars, identify potential roles and responsibilities of pharmacists regarding biologic and biosimilar medications, and identify actions or activities that pharmacists may take to optimize the safe and cost-effective use of biologics and biosimilars...
July 6, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28686780/a-survey-assessment-of-us-dermatologists-perception-of-biosimilars
#14
Alexandra Barsell, Monica Rengifo-Pardo, Alison Ehrlich
<p>BACKGROUND: Biologics have transformed the treatment of psoriasis and psoriatic arthritis, but at a significant cost to payers and patients. The introduction of biosimilars into the US market could reduce costs while increasing access to biologic medications.</p> <p>OBJECTIVE: We sought to identify gaps in biosimilar knowledge and perception among US dermatologists.</p> <p>METHODS: An online survey was sent to dermatologists from January to April 2015.</p> <p>RESULTS: Ninety-seven US dermatologists responded, of which 84% state they prescribe biologics in their practice...
June 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/28666961/assessing-awareness-and-attitudes-of-healthcare-professionals-on-the-use-of-biosimilar-medicines-a-survey-of-physicians-and-pharmacists-in-ireland
#15
Joan O'Callaghan, Margaret Bermingham, Maurice Leonard, Frank Hallinan, J Michael Morris, Una Moore, Brendan T Griffin
Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in Ireland. Physicians were invited to complete an online questionnaire during April and May 2016. Community pharmacists received a postal questionnaire in August 2015. Responses from 102 medical specialists, 253 GPs and 125 community pharmacists were analysed...
June 27, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28660473/assessing-the-value-of-biosimilars-a-review-of-the-role-of-budget-impact-analysis
#16
REVIEW
Steven Simoens, Ira Jacobs, Robert Popovian, Leah Isakov, Lesley G Shane
Biosimilar drugs are highly similar to an originator (reference) biologic, with no clinically meaningful differences in terms of safety or efficacy. As biosimilars offer the potential for lower acquisition costs versus the originator biologic, evaluating the economic implications of the introduction of biosimilars is of interest. Budget impact analysis (BIA) is a commonly used methodology. This review of published BIAs of biosimilar fusion proteins and/or monoclonal antibodies identified 12 unique publications (three full papers and nine congress posters)...
June 28, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28652703/ct-p13-design-development-and-place-in-therapy
#17
REVIEW
Tommaso Gabbani, Simona Deiana, Vito Annese
The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28650704/is-there-a-reason-for-concern-or-is-it-just-hype-a-systematic-literature-review-of-the-clinical-consequences-of-switching-from-originator-biologics-to-biosimilars
#18
András Inotai, Christiaan P J Prins, Marcell Csanádi, Dinko Vitezic, Catalin Codreanu, Zoltán Kaló
While prescribing biosimilars to patients naive to a biologic treatment is a well-accepted practice, switching clinically stable patients from an originator to a biosimilar is an issue for clinicians. Well-designed clinical trials and real-world data which study the consequences of switching from an originator biologic treatment to its biosimilar alternative are limited, especially for monoclonal antibodies. Areas covered: A systematic literature review was conducted on PubMed to identify evidence of the consequences of switching from original biologics to biosimilars...
June 26, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28646580/biosimilars-for-psoriasis-worldwide-overview-of-regulatory-guidelines-uptake-and-implications-for-dermatology-clinical-practice
#19
REVIEW
A D Cohen, J J Wu, L Puig, S Chimenti, R Vender, M Rajagopalan, R Romiti, C de la Cruz, L Skov, C Zachariae, H S Young, P Foley, J M van der Walt, L Naldi, A Blauvelt
The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis...
June 24, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28642700/pricing-and-reimbursement-of-biosimilars-in-central-and-eastern-european-countries
#20
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Pero Draganic
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country...
2017: Frontiers in Pharmacology
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