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Biologics/ Biosimilars

Edoardo Botteri, Andriy Krendyukov, Giuseppe Curigliano
BACKGROUND: Granulocyte colony-stimulating factors (G-CSFs) are widely used to prevent neutropenia in cancer patients undergoing myelosuppressive chemotherapy. Several biosimilar medicines of G-CSF are now available, with their development involving a step-wise series of comparisons to demonstrate similarity to reference biologics. Randomised clinical trials (RCTs) are considered confirmatory, and for G-CSF biosimilars, patients with breast cancer (BC) undergoing myelosuppressive chemotherapy are the most sensitive population in which to confirm similarity...
December 8, 2017: European Journal of Cancer
Iain Simpson
This industry update covers the period from 1 September through 30 September 2017, and is based on information sourced from company press releases, scientific literature, patents and various news websites. The month saw the US FDA approve three new molecular entities, Aliqopa (copanlisib dihydrochloride) (Bayer Healthcare); Solosec (secnidazole) (Symbiomix Therapeutics) and Verzenio (abemaciclib) (Eli Lilly and Co). Intarcia Therapeutics Inc. has its application for approval of a novel drug device combination of exenatide for the treatment of diabetes rejected by FDA but said that it will work to address the concerns and refile the application...
January 2018: Therapeutic Delivery
Jennifer R Brown, Florence Cymbalista, Jeff Sharman, Ira Jacobs, Pilar Nava-Parada, Anthony Mato
Chronic lymphocytic leukemia (CLL) is managed with observation for asymptomatic or clinically silent disease; pharmacologic intervention is generally required for symptomatic patients with clinically significant adenopathy or cytopenia. In the front-line treatment of CLL, the current standard-of-care includes chemotherapy in combination with an anti-CD20 monoclonal antibody (e.g., rituximab, ofatumumab, or obinutuzumab) or ibrutinib as single agent. Despite the evolving treatment paradigm toward targeted therapy, it is likely that rituximab (plus chemotherapy), with or without targeted agents, will retain a significant role in CLL treatment...
December 6, 2017: Oncologist
Pedro Avila-Ribeiro, Gionata Fiorino, Silvio Danese
BACKGROUND: biosimilars are similar versions of existing innovator biologic agents but with distinct manufacturing processes. They were approved in inflammatory bowel disease (IBD) by extrapolation of indication from rheumatic diseases. As regulatory requirements for biosimilar approval focus on pre-clinical evidence of similarity rather than clinical data on efficacy, safety and immunogenicity, it is critical to review clinical evidence supporting their use in IBD in order to overcome reluctance from patients and clinicians alike...
December 3, 2017: Current Pharmaceutical Design
Isabel Andujar Perez, Ana Blas-Garcia, Loreto Carmona, Juan V Esplugues
BACKGROUND: Biological products are subject to constant reappraisal by regulatory agencies and pharmaceutical companies once they have entered the market, since every improvement in their manufacturing process has the potential to alter the basic properties of these molecules. METHODS: Narrative review focusing on scientific literature as well as legal documents from regulatory agencies. RESULTS: Evaluating the impact of each manufacturing change of these drugs requires rigorous analyses in proportion to the anticipated risk of inducing more or less molecular micro-heterogenicity...
December 3, 2017: Current Pharmaceutical Design
Vivian A Fonseca, Zachary T Bloomgarden, Samuel Dagogo-Jack, George Grunberger, Daniel Einhorn, Alan J Garber, Yehuda Handelsman, Irl B Hirsch, Guillermo E Umpierrez
This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position and consensus statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician...
November 2017: Endocrine Practice
Srilakshmi M Sharma, Dun Jack Fu, Kanmin Xue
Systemic immunomodulatory therapies are the principal means of managing non-infectious uveitis. This review aims to explore the current landscape of systemic uveitis treatments, including biologic therapies and the advent of biosimilar therapies.
November 30, 2017: Ophthalmology and Therapy
Mary Ann Chapman, David Charles, Arturo Loaiza-Bonilla
BACKGROUND: Biosimilars have the potential to create competition, lower costs, and increase patient access to biological medications. However, biological medications are sensitive to their manufacturing processes and difficult to precisely characterize, leading to questions about substitution and interchangeability among products. METHODS: This article reviews the role of biosimilars in patient access to therapeutic antibodies. RESULTS: Although pathways for the approval of biosimilars have been developed, important issues remain unresolved...
November 29, 2017: Current Pharmaceutical Design
Marta Pentek, Zsombor Zrubka, Laszlo Gulacsi
BACKGROUND: Biological drugs represent highly effective but costly treatments for chronic immune-mediated inflammatory diseases posing substantial burden on health care budgets. Introduction of biosimilars since 2013 has brought forward the potential of market competition, and as a societal benefit, the hope of increased access at a lower cost. OBJECTIVE: We aim to provide a descriptive review on economic aspects and market changes related to the introduction of biosimilar drugs...
November 29, 2017: Current Pharmaceutical Design
Iris Detrez, Ann Gils
BACKGROUND: The expiry of the patent of several leading biological medicinal products has led to a surge in the development of 'biosimilar' products. In contrast to generic small-molecule medicines, biosimilars are not identical to their reference medicinal products. METHODS: Full comparability in quality as well as in preclinical and clinical issues is required to register a biosimilar. Since immunogenicity is key for biological medicinal products, regulatory authorities in the European Union require antidrug antibody (ADA) responses to be evaluated and to be approached from a safety perspective...
November 29, 2017: Current Pharmaceutical Design
Sizheng Zhao, Jagdish R Nair, Robert J Moots
BACKGROUND: Biologic drugs have revolutionised the management of many inflammatory conditions. Patent expirations have stimulated development of highly similar but non-identical molecules, the biosimilars. Extrapolation of indications is a key concept in the development of biosimilars. However, this has been met with concerns around mechanisms of action, equivalence in efficacy and immunogenicity, which are reviewed in this article. METHODS: Narrative overview composed from literature search and the authors' experience...
November 29, 2017: Current Pharmaceutical Design
Gianluca Trifirò, Ilaria Marcianò, Ylenia Ingrasciotta
Since 2006, biosimilars have been available in several countries worldwide, thus allowing for potential savings in pharmaceutical expenditure. However, there have been numerous debates about the interchangeability of biosimilars and reference products based on concerns of immunogenicity by switching between biological products, which may cause lack of effect and toxicity. Areas covered: The authors provide the reader with an overview of the different positions of regulatory authorities on the interchangeability and automatic substitution of biosimilars and reference products...
November 29, 2017: Expert Opinion on Biological Therapy
Olivier Bruyère, Cyrus Cooper, Nasser M Al-Daghri, Elaine M Dennison, René Rizzoli, Jean-Yves Reginster
Osteoarthritis (OA) is a progressive joint disease, that occurs frequently in the aging population and is a major cause of disability worldwide. Both glucosamine and chondroitin are biologically active molecules that are substrates for proteoglycan, an essential component of the cartilage matrix. Evidence supports the use of glucosamine and chondroitin as symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) with impact on OA symptoms and disease-modifying effects in the long term. Glucosamine and chondroitin are administered in exogenous form as a sulfate salt and multiple formulations of these agents are available, both as prescription-grade products and nutritional supplements...
November 24, 2017: Aging Clinical and Experimental Research
Donglin Zeng, Jean Pan, Kuolung Hu, Eric Chi, D Y Lin
To improve patients' access to safe and effective biological medicines, abbreviated licensure pathways for biosimilar and interchangeable biological products have been established in the US, Europe, and other countries around the world. The US Food and Drug Administration and European Medicines Agency have published various guidance documents on the development and approval of biosimilars, which recommend a "totality-of-the-evidence" approach with a stepwise process to demonstrate biosimilarity. The approach relies on comprehensive comparability studies ranging from analytical and nonclinical studies to clinical pharmacokinetic/pharmacodynamic (PK/PD) and efficacy studies...
November 27, 2017: Journal of Biopharmaceutical Statistics
Sreedhar Sagi, Hillel P Cohen, Gillian R Woollett
It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics...
December 2017: Journal of Managed Care & Specialty Pharmacy
Edward Li, Ernesto Lobaina
BACKGROUND: The FDA's extrapolation framework allows for a biosimilar to obtain licensure for indications that were not explicitly studied in the context of a clinical trial by extending conclusions from studies in 1 population to make inferences in other populations. Within routine clinical care, drugs and biologics are routinely used for medically accepted off-label indications. The appropriateness of these products for off-label indications are typically curated by compendia and guidelines, which have established processes and criteria for reviewing and evaluating the evidence to make such determinations...
December 2017: Journal of Managed Care & Specialty Pharmacy
Foluso Agboola, Prabashni Reddy
BACKGROUND: In 2008, tbo-filgrastim was approved as a biosimilar in Europe and then approved in the United States by the FDA in 2012 as a biologic product with 1 similar indication to filgrastim. Because tbo-filgrastim was less expensive than filgrastim, and clinical information and expert opinion supported similarity, the Pharmacy & Therapeutics Committee of a large health care system approved tbo-filgrastim as the preferred granulocyte-colony stimulating factor (G-CSF) product in March 2014...
December 2017: Journal of Managed Care & Specialty Pharmacy
Anna Hung, Quyen Vu, Lisa Mostovoy
BACKGROUND: Biosimilars undergo an abbreviated licensure pathway called 351(k), which was created by the Biologics Price Competition and Innovation Act of 2009. This approval process is different from the 351(a) pathway for original biologic approval and, as of August 2017, has been used to approve 5 biosimilars in the United States. OBJECTIVE: To identify the types and quantities of evidence required by the FDA for biosimilar approval and the corresponding evidence manufacturers have provided in their 351(k) biosimilar approval applications...
December 2017: Journal of Managed Care & Specialty Pharmacy
Sonia T Oskouei
Over 2 years have passed since the first biosimilar was approved for use in the United States. Despite a relatively slow start, biosimilar activity has significantly increased in recent months. Biologics are the most expensive drug category in the United States, costing patients hundreds or even thousands of dollars per year. Biosimilars have the potential to significantly decrease cost of care, increase access, and improve patient outcomes. In order to realize the potential savings, biosimilar manufacturers, health care providers, and payers must develop strategies to navigate the challenging health care environment and understand where and how biosimilars bring the most value to patients...
December 2017: Journal of Managed Care & Specialty Pharmacy
Serdal Korkmaz, Fevzi Altuntas
Mobilization of hematopoietic stem cells, which has largely replaced bone marrow harvesting as a source of hematopoietic stem cells, using recombinant agents such as filgrastim or lenograstim has become a standard procedure in both patients and healthy donors prior to peripheral blood stem cell collection for autologous and allogeneic stem cell transplantation. Published literature data suggest that mobilization with recombinant granulocyte-colony stimulating factor (G-CSF) is safe and mobilization outcomes are satisfactory...
November 8, 2017: Transfusion and Apheresis Science
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