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Biologics/ Biosimilars

Timothy M Pierpont, Candice B Limper, Kristy L Richards
Rituximab is a chimeric mouse/human monoclonal antibody (mAb) therapy with binding specificity to CD20. It was the first therapeutic antibody approved for oncology patients and was the top-selling oncology drug for nearly a decade with sales reaching $8.58 billion in 2016. Since its initial approval in 1997, it has improved outcomes in all B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. Despite widespread use, most mechanistic data have been gathered from in vitro studies while the roles of the various response mechanisms in humans are still largely undetermined...
2018: Frontiers in Oncology
Eric J M Blondeel, Marc G Aucoin
Glycosylation is a critical quality attribute (CQA) of many therapeutic proteins, particularly monoclonal antibodies (mAbs), and is a major consideration in the approval of biosimilar biologics due to its effects to therapeutic efficacy. Glycosylation generates a distribution of glycoforms, resulting in glycoproteins with inherent molecule-to-molecule heterogeneity, capable of activating (or failing to activate) different effector functions of the immune system. Glycoforms can be affected by the supplementation of nucleotide-sugar precursors, and related components, to culture growth medium, affecting the metabolism of glycosylation...
June 15, 2018: Biotechnology Advances
N A Nixon, M B Hannouf, S Verma
Cancer therapy has evolved significantly with increased adoption of biologic agents ("biologics"). That evolution is especially true for her2 (human epidermal growth factor receptor-2)-positive breast cancer with the introduction of trastuzumab, a monoclonal antibody against the her2 receptor, which, in combination with chemotherapy, significantly improves survival in both metastatic and early disease. Although the efficacy of biologics is undeniable, their expense is a significant contributor to the increasing cost of cancer care...
June 2018: Current Oncology
María Fernanda Guerra Veloz, Juan María Vázquez Morón, María Belvis Jiménez, Héctor Pallarés Manrique, Teresa Valdés Delgado, Luisa Castro Laria, Belén Maldonado Pérez, Antonio Benítez Roldán, Raúl Perea Amarillo, Vicente Merino, Ángel Caunedo Álvarez, Federico Argüelles Arias
BACKGROUND AND AIMS: infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD. METHODS: this was a multicenter prospective observational study in patients with Crohn's disease (CD) and ulcerative colitis (UC)...
June 12, 2018: Revista Española de Enfermedades Digestivas
Hiroshi Kyono, Kayo Haraguchi, Shota Kojima, Takumi Ota, Chulho Jung, Sung Mo Yang, Sangwoo Park, Jineon So, Sunyoung Kim, Jooncheol Kwon, Suyeon Ko, Minae Yun
Etanercept is a dimeric genetic recombinant glycoprotein consisting of Fc domain of human Immunoglobulin G1 and the extracellular domain of human tumor necrosis factor (TNF) receptor type II. Etanercept exerts therapeutic effects on inflammatory diseases such as rheumatoid arthritis and juvenile idiopathic arthritis by neutralizing biological activities of TNFα/Lymphotoxin (LT) α. Mochida Pharmaceutical and LG Chem have developed syringe, pen, and vial products of Etanercept BS (biosimilar) as the first biosimilar of Enbrel in Japan...
2018: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
Mourad F Rezk, Burkhard Pieper
In addition to the general clinical benefit offered, biosimilars may not only generate savings for healthcare budgets but also improve patient access to biologic products. Since the first biosimilar was approved in Europe in 2006, a further 36 different biosimilar drugs have been approved for several indications. Despite the wealth of experience gained and the reported data supporting the use of biosimilars, both in naïve and biologic-experienced patients, some healthcare professionals continue to express doubt regarding the rigorous approval process for biosimilars and uncertainty with how to incorporate them into daily clinical practice...
June 5, 2018: Advances in Therapy
Prashanth Rawla, Tagore Sunkara, Jeffrey Pradeep Raj
Inflammatory bowel disease (IBD) is an idiopathic chronic inflammatory disease of the gastrointestinal system. The spectrum is of predominantly two types, namely, ulcerative colitis and Crohn's disease. The incidence of IBD has been increasing steadily since 1990, and so the number of agents used in their treatment. Biologics that are derived partly or completely from living biological sources such as animals and humans have become widely available, which provide therapeutic benefits to the IBD patients. Currently, monoclonal antibodies against tumor necrosis factor-alpha (infliximab, adalimumab, certolizumab, and golimumab), integrins (vedolizumab and natalizumab), and interleukin (IL)-12 and IL-23 antagonists (ustekinumab) are approved for use in IBD...
2018: Journal of Inflammation Research
Tomasz Sarosiek, Paweł Morawski
Trastuzumab is a monoclonal antibody used as a standard treatment for breast and metastatic gastric cancer when the cancer cells overexpress HER2, a membrane-bound receptor activated by EGF family of ligands. Due to the high cost of the therapy and no refund of the drug in many countries, there is still a large group of patients who do not have the opportunity to receive trastuzumab. A biosimilar is a medical product highly similar to another already approved biological medicine. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines...
May 25, 2018: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
Mohammed I Aladul, Raymond W Fitzpatrick, Stephen R Chapman
BACKGROUND: The approval of new biosimilars of infliximab, etanercept and adalimumab by the European Medicines Agency is expected to produce further cost savings to the healthcare system budget. OBJECTIVES: This study aimed to estimate the budget impact of the introduction of new biosimilars Flixabi® , Erelzi® , Solymbic® , Amgevita® and Imraldi® in rheumatology and gastroenterology specialities in the UK. METHODS: A published budget impact model was adapted to estimate the expected cost savings following the entry of new biosimilars Flixabi® , Erelzi® , Solymbic® , Amgevita® and Imraldi® in the UK over three-year time horizon...
May 15, 2018: Research in Social & Administrative Pharmacy: RSAP
Robert E Weiss, Xiaomao Xia, Nan Zhang, Hui Wang, Eric Chi
A biologic is a product made from living organisms. A biosimilar is a new version of an already approved branded biologic. Regulatory guidelines recommend a totality-of-the-evidence approach with stepwise development for a new biosimilar. Initial steps for biosimilar development are (a) analytical comparisons to establish similarity in structure and function followed by (b) potential animal studies and a human pharmacokinetics/pharmacodynamics equivalence study. The last step is a phase III clinical trial to confirm similar efficacy, safety, and immunogenicity between the biosimilar and the biologic...
May 23, 2018: Statistics in Medicine
Paul Emery, Marjolijn Van Keep, Steve Beard, Chris Graham, LaStella Miles, Steffen Marc Jugl, Praveen Gunda, Anna Halliday, Helena Marzo-Ortega
OBJECTIVE: To determine the cost effectiveness of secukinumab, a fully human interleukin-17A inhibitor, for adults in the UK with active ankylosing spondylitis (AS) who have not responded adequately to previous treatment with conventional care (CC; biologic-naïve population) or previous biologic therapy (biologic-experienced population). PERSPECTIVE AND SETTING: UK National Health Service (NHS). METHODS: The model was structured as a 3-month decision tree leading into a Markov model...
May 25, 2018: PharmacoEconomics
Ylenia Ingrasciotta, Paola M Cutroneo, Ilaria Marcianò, Thijs Giezen, Fabiola Atzeni, Gianluca Trifirò
In recent years, marketing of highly innovative and costly biologics improved the management of high-burden diseases such as autoimmune diseases, cancers, and chronic renal failure. Several widely prescribed biologics have recently lost or will shortly lose their patents, thus opening avenues to the marketing of a growing number of biosimilars worldwide, which are products similar in terms of quality, safety, and efficacy to already licensed reference products, thus allowing for potential savings in pharmaceutical expenditure...
May 23, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Kirsten B Goldberg, Gideon M Blumenthal, Richard Pazdur
The Food and Drug Administration formally established the Oncology Center of Excellence (OCE) in January 2017, as authorized by the 21st Century Cures Act, to expedite the development and review of certain drugs, biologics, and devices for the treatment of cancer. In its first year, the OCE conducted the clinical reviews for several products, including the first 2 chimeric antigen receptor T-cell therapies approved for the treatment of advanced hematologic malignancies and an in vitro diagnostic next-generation sequencing panel, FoundationOne CDx...
May 2018: Cancer Journal
Ori Rackovsky, Robert Hirten, Ryan Ungaro, Jean-Frederic Colombel
Perianal fistulizing disease is an aggressive and debilitating phenotype of Crohn's disease (CD), representing a significant therapeutic challenge. New work has led to advancement in epidemiology and long term outcomes of perianal disease. The range of therapeutic options continues to expand, including new biologic agents, biosimilars, and stem cell therapy. Areas covered: We discuss updates to all aspects of management of perianal disease, with a focus on the last three years of published data. Areas considered include new data on epidemiology and prognostication, medical and surgical therapy, and stem cell therapy...
May 24, 2018: Expert Review of Gastroenterology & Hepatology
Gary H Lyman, Robin Zon, R Donald Harvey, Richard L Schilsky
Biologic therapies for cancer and other disorders contribute to improved outcomes for many patients but also account for a large proportion of health care expenditures. Opportunities for cost containment may emerge as the patents on originator products expire and highly similar agents known as..
May 24, 2018: New England Journal of Medicine
Robert J Moots, Cinzia Curiale, Danielle Petersel, Catherine Rolland, Heather Jones, Eduardo Mysler
OBJECTIVE: Regulatory approval of biosimilar versions of originator biotherapeutics requires that new biological products be highly similar to originator products, with no clinically meaningful differences in safety, purity, and potency. In some trials of biosimilars of tumor necrosis factor inhibitors for the treatment of rheumatoid arthritis (RA) and plaque psoriasis (PsO), pre-specified margins for efficacy and safety have been met, but differences in treatment responses between pivotal originator trials and biosimilar trials have been noted...
May 22, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Eduardo Cazap, Ira Jacobs, Ali McBride, Robert Popovian, Karol Sikora
Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics...
May 16, 2018: Oncologist
Maria Greenwald, John Tesser, K Lea Sewell
A biosimilar is a biologic product that is highly similar to a licensed biologic ("originator") such that there are no clinically meaningful differences in safety, purity, or potency between the biosimilar and the originator. As patent protection and data exclusivity for the biologic rituximab expire, several potential biosimilars to rituximab are in development, which could soon lead to the availability of numerous rituximab biosimilars. Biosimilars are evaluated using thorough and rigorous analyses of the potential biosimilar versus the originator biological to confirm similar structure, function, and clinical efficacy as well as safety...
2018: Arthritis
Simrun Grewal, Scott Ramsey, Sanjeev Balu, Josh J Carlson
OBJECTIVE: Biosimilars can directly reduce the cost of treating patients for whom a reference biologic is indicated by offering a highly similar, lower priced alternative. We examine factors related to biosimilar regulatory approval, uptake, pricing, and financing and the potential impact on drug expenditures in the U.S. METHODS: We developed a framework to illustrate how key factors including regulatory policies, provider and patient perception, pricing, and payer policies impact biosimilar cost-savings...
May 14, 2018: Expert Review of Pharmacoeconomics & Outcomes Research
Steven R Feldman, Jerry Bagel, Shahla Namak
The introduction of biologics has revolutionized the treatment of immune-mediated diseases, but high cost and limited patient access remain hurdles, and some physicians are concerned that biosimilars are not similar enough. The purpose of this narrative review is to describe biosimilar safety, efficacy, nomenclature, extrapolation and interchangeability. In the United States, the Biologics Price Competition and Innovation Act created an abbreviated pathway for licensing of a biologic that is biosimilar to another licensed product (i...
May 2018: American Journal of the Medical Sciences
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