Current Status of Biosimilars in Oncology.

Abstract:

:Four medicinal cancer biological blockbusters will end their patent lifespan by 2020. It is estimated that the total market for cancer biologicals will reach approximately US$68 billion at that time. Approximately 20 biosimilars have entered the European market since the launch of the original approval guidelines in 2005, and four biosimilars have been approved in the USA since 2015. Data from European countries with the highest market entrance of biosimilars suggest that the incorporation of biosimilars into healthcare systems worldwide may result in a 30-45% cost savings. Initial levels of apprehension expressed by healthcare providers regarding the safety and efficacy of integrating biosimilars into the treatment of cancer patients have gradually decreased through active educational programs. The trust generated by regulatory agencies and drug manufacturers will ultimately make the adoption of biosimilars by healthcare providers and patients a smooth process. Future efforts to improve on the global acceptance and safety of biosimilars must include standardization of naming, regulatory requirements, and pharmacovigilance programs worldwide. High expectations are being placed on the cost savings, safety, and efficacy of these products. The entry costs for biosimilars and the pricing reaction of their originator products will determine the true savings by troubled health systems in dire need of cost cuts. This article discusses basic principles of biosimilars in hematology and oncology, the current status of their clinical development, and trends of acceptance by healthcare providers, and provides insight into potential future challenges.

journal_name

Drugs

journal_title

Drugs

authors

Camacho LH

doi

10.1007/s40265-017-0743-z

subject

Has Abstract

pub_date

2017-06-01 00:00:00

pages

985-997

issue

9

eissn

0012-6667

issn

1179-1950

pii

10.1007/s40265-017-0743-z

journal_volume

77

pub_type

杂志文章,评审

相关文献

DRUGS文献大全
  • Emerging resistance to antimicrobial agents in gram-positive bacteria. Pneumococci.

    abstract::The prevalence of penicillin-resistant pneumococci is increasing worldwide. Methods for susceptibility testing, as well as in vitro susceptibility of penicillin-susceptible and -resistant strains to new and existing agents (including oral and parenteral streptogramins), are described. For all specimens except CSF, oxa...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-199600511-00003

    authors: Appelbaum PC

    更新日期:1996-01-01 00:00:00

  • Management of gastroenteritis in early childhood.

    abstract::The most important aspect of modern management of acute diarrhoeal illness in children is that of oral rehydration therapy, and drug therapy is very rarely indicated. Despite the dramatic decline in mortality and morbidity in recent years, there is still the need for continuing education in the appropriate use of oral...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-199244010-00005

    authors: Davies A,Jenkins HR

    更新日期:1992-07-01 00:00:00

  • Susoctocog Alfa: A Review in Acquired Haemophilia A.

    abstract::Intravenous susoctocog alfa (Obizur(®)) is a recombinant, B-domain deleted, porcine sequence antihaemophilic factor VIII (FVIII) product that has recently been approved for the treatment of bleeding episodes in adults with acquired haemophilia A (AHA). Intravenous susoctocog alfa was an effective and generally well to...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-016-0576-1

    authors: Burness CB,Scott LJ

    更新日期:2016-05-01 00:00:00

  • Caspofungin: a review of its use in oesophageal candidiasis, invasive candidiasis and invasive aspergillosis.

    abstract::Echinocandins are a new class of antifungal agents with a novel mechanism of action (interference with fungal cell wall synthesis). Caspofungin (Cancidas), Caspofungin MSD) is the first echinocandin to be approved and is administered intravenously. Caspofungin 50 mg/day had similar efficacy to intravenous fluconazole ...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200363200-00008

    authors: Keating G,Figgitt D

    更新日期:2003-01-01 00:00:00

  • Current status of dopamine agonists in Parkinson's disease management.

    abstract::The occurrence of late side effects of long term levodopa therapy (fluctuations in motor performance, abnormal movements, and symptoms unresponsive to dihydroxyphenylalanine) led to the search for novel anti-Parkinsonian drugs. Dopamine agonists are one of the newer families of anti-Parkinsonian agents, and they inclu...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-199346030-00005

    authors: Montastruc JL,Rascol O,Senard JM

    更新日期:1993-09-01 00:00:00

  • Sitagliptin: a review of its use in patients with type 2 diabetes mellitus.

    abstract::Sitagliptin (Januvia(®), Xelevia™, Glactiv(®), Tesavel(®)) is an orally administered, potent and highly selective inhibitor of dipeptidyl peptidase-4 (DPP-4) and was the first agent of its class to be approved for use in the management of adults with type 2 diabetes. Numerous randomized placebo- or active comparator-c...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-013-0169-1

    authors: Plosker GL

    更新日期:2014-02-01 00:00:00

  • Pomalidomide: A Review in Relapsed and Refractory Multiple Myeloma.

    abstract::Pomalidomide (Imnovid®; Pomalyst®), an analogue of thalidomide, is an immunomodulatory agent, with several mechanisms of action (both direct and indirect) thought to be involved in its anti-myeloma activity. Oral pomalidomide is available in several countries for use in combination with low-dose dexamethasone in adult...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-017-0833-y

    authors: Hoy SM

    更新日期:2017-11-01 00:00:00

  • Tumour necrosis factor in chronic heart failure: a peripheral view on pathogenesis, clinical manifestations and therapeutic implications.

    abstract::The development of chronic heart failure (CHF) includes phenotypic changes in a host of homeostatic systems so that, as the disease advances, CHF may be seen as a multi-system disorder with its origins in the heart but embracing many extra-cardiac manifestations. Immunological abnormalities are recognised in this cont...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200060060-00002

    authors: Bolger AP,Anker SD

    更新日期:2000-12-01 00:00:00

  • The coming era of quadrivalent human influenza vaccines: who will benefit?

    abstract::Influenza vaccines form the mainstay of public health and personal protection against infection with seasonal influenza viruses. These vaccines are designed to protect people against infection with the currently circulating influenza viruses. Since the late 1970s, this has required the use of a trivalent vaccine consi...

    journal_title:Drugs

    pub_type: 杂志文章

    doi:10.2165/11641110-000000000-00000

    authors: Barr IG,Jelley LL

    更新日期:2012-12-03 00:00:00

  • Recent Advances in the Development of Antineoplastic Agents Derived from Natural Products.

    abstract::Through years of evolutionary selection pressures, organisms have developed potent toxins that coincidentally have marked antineoplastic activity. These natural products have been vital for the development of multiagent treatment regimens currently employed in cancer chemotherapy, and are used in the treatment of a va...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-015-0489-4

    authors: Trendowski M

    更新日期:2015-11-01 00:00:00

  • Alipogene tiparvovec: a review of its use in adults with familial lipoprotein lipase deficiency.

    abstract::Alipogene tiparvovec (Glybera®; AMT-011, AAV1-LPL(S447X)) is an adeno-associated virus serotype 1-based gene therapy for adult patients with familial lipoprotein lipase (LPL) deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions. It is administered as a one-time ...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-014-0339-9

    authors: Scott LJ

    更新日期:2015-02-01 00:00:00

  • Tuberculosis and HIV co-infection: screening and treatment strategies.

    abstract::Globally, tuberculosis (TB) and HIV interact in deadly synergy. The high burden of TB among HIV-infected individuals underlies the importance of TB diagnosis, treatment and prevention for clinicians involved in HIV care. Despite expanding access to antiretroviral therapy (ART) to treat HIV infection in resource-limite...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/11591360-000000000-00000

    authors: Venkatesh KK,Swaminathan S,Andrews JR,Mayer KH

    更新日期:2011-06-18 00:00:00

  • Targeted Therapy for Chronıc Spontaneous Urtıcarıa: Ratıonale and Recent Progress.

    abstract::Chronic spontaneous urticaria (CSU) is characterized by the presence of wheals, angioedema, or both for at least 6 weeks. It may persist for a long time-up to 50% of the patients have been reported to be symptomatic 5 years after the onset. Some patients can suffer more than one episode of CSU during their lifetime. C...

    journal_title:Drugs

    pub_type: 杂志文章

    doi:10.1007/s40265-020-01387-9

    authors: Giménez-Arnau AM,Salman A

    更新日期:2020-11-01 00:00:00

  • Statins and pregnancy: between supposed risks and theoretical benefits.

    abstract::Cardiovascular diseases are the leading cause of mortality in industrialized countries. Treatment with statins is effective in primary prevention in patients at high cardiovascular risk. Statins are inhibitors of hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase and are classed as lipid-lowering drugs. In 2010, ato...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/11632010-000000000-00000

    authors: Lecarpentier E,Morel O,Fournier T,Elefant E,Chavatte-Palmer P,Tsatsaris V

    更新日期:2012-04-16 00:00:00

  • Etanercept: a review of its use in autoimmune inflammatory diseases.

    abstract::With its approval more than 15 years ago, subcutaneous etanercept (Enbrel(®)) was the first biological disease-modifying antirheumatic drug (bDMARD) and the first tumour necrosis factor inhibitor to be approved for use in rheumatic diseases. Etanercept remains an important cost-effective treatment option in adult pati...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-014-0258-9

    authors: Scott LJ

    更新日期:2014-08-01 00:00:00

  • Oral antidiabetic agents: current role in type 2 diabetes mellitus.

    abstract::Type 2 diabetes mellitus is a progressive and complex disorder that is difficult to treat effectively in the long term. The majority of patients are overweight or obese at diagnosis and will be unable to achieve or sustain near normoglycaemia without oral antidiabetic agents; a sizeable proportion of patients will eve...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200565030-00005

    authors: Krentz AJ,Bailey CJ

    更新日期:2005-01-01 00:00:00

  • Pharmacotherapy for oesophagogastric cancer.

    abstract::Gastric cancer is the seventh and oesophageal cancer the ninth most common cancer in the UK, and >50% of patients present with locally advanced or metastatic disease. The incidence of oesophageal and oesophagogastric junctional tumours is increasing, making these important disease entities to understand and research. ...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200767170-00006

    authors: Jackson C,Starling N,Chua YJ,Cunningham D

    更新日期:2007-01-01 00:00:00

  • Stavudine: a review of its pharmacodynamic and pharmacokinetic properties and clinical potential in HIV infection.

    abstract::Stavudine is a nucleoside analogue which undergoes intracellular phosphorylation to its active metabolite, stavudine-5'-triphosphate. At clinically relevant concentrations, the active metabolite restricts HIV replication by inhibiting the inclusion of thymidine-5'-triphosphate into proviral DNA by HIV reverse transcri...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-199651050-00009

    authors: Lea AP,Faulds D

    更新日期:1996-05-01 00:00:00

  • Desirable therapeutic characteristics of an optimal antihypertensive agent.

    abstract::Hypertension affects 65 million people in the US, and is a major cause of morbidity and mortality, but less than one-third of patients with hypertension are treated to goal blood pressure. Multiple factors have been cited, and include suboptimal adherence to treatment and lifestyle modifications, limited access to hea...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200666090-00006

    authors: Mustone Alexander L

    更新日期:2006-01-01 00:00:00

  • Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.

    abstract::Bevacizumab is a recombinant, humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody that neutralizes the biological activity of VEGF and inhibits tumour angiogenesis. In two pivotal, well designed, phase III, clinical trials (GOG-0218 and ICON7) in women with advanced epithelial ovarian, fallopi...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/11208940-000000000-00000

    authors: Dhillon S

    更新日期:2012-05-07 00:00:00

  • Management of cystitis in young women.

    abstract::The common clinical problem of recurrent symptomatic urinary tract infections (UTI) in young women may be inconvenient and distressing to both the patient and her family, particularly if the infections are not managed in a rational manner. A suggested approach is included in table 1. ...

    journal_title:Drugs

    pub_type: 杂志文章

    doi:10.2165/00003495-197713020-00003

    authors: Bailey RR

    更新日期:1977-02-01 00:00:00

  • A clinical assessment of the potential for pharmacological interaction between nimesulide and digoxin in patients with heart failure.

    abstract::The potential interaction between nimesulide, a nonsteroidal anti-inflammatory drug, and digoxin was studied in 9 patients [6 males, 3 females; mean age 67 (range 57 to 70) years] with mild heart failure. All patients were receiving maintenance therapy with digoxin (0.25 mg/day, orally) and were treated with oral nime...

    journal_title:Drugs

    pub_type: 杂志文章

    doi:10.2165/00003495-199300461-00017

    authors: Baggio E,Maraffi F,Montalto C,Nava ML,Torti L,Casciarri I

    更新日期:1993-01-01 00:00:00

  • Clostridium difficile-associated disease: changing epidemiology and implications for management.

    abstract::Clostridium difficile-associated disease (CDAD) is increasingly being reported in many regions throughout the world. The reasons for this are unknown, are likely to be multifactorial, and are the subject of several current investigations. In addition to the upsurge in frequency of CDAD, an increased rate of relapse/re...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-200767040-00001

    authors: Owens RC

    更新日期:2007-01-01 00:00:00

  • Upper respiratory tract infections. Ecological and therapeutic aspects of beta-lactamase production with special reference to Branhamella catarrhalis.

    abstract::Available data indicate that the most common beta-lactamase produced by Branhamella catarrhalis is plasmid mediated. The same enzyme occurs in Moraxella nonliquefaciens, a commensal in the upper respiratory tract. The ability to produce the enzyme, which is known as BRO-1, can be transferred by conjugation from M. non...

    journal_title:Drugs

    pub_type: 杂志文章

    doi:10.2165/00003495-198600313-00026

    authors: Eliasson I,Kamme C

    更新日期:1986-01-01 00:00:00

  • Induction therapy in renal transplant recipients: how convincing is the current evidence?

    abstract::The goal of organ transplantation is to provide durable organ function while minimizing risks such as infection and cancer. Induction therapy in renal transplantation provides improved short- and long-term graft outcomes compared with placebo. Three agents are currently available and widely used in the US; rabbit anti...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/11631300-000000000-00000

    authors: Wagner SJ,Brennan DC

    更新日期:2012-03-26 00:00:00

  • Pimavanserin: First Global Approval.

    abstract::Pimavanserin (Nuplazid™) is a selective and potent serotonin 2A (5-HT2A) receptor inverse agonist and antagonist developed by ACADIA Pharmaceuticals that has been approved in the US as a treatment for patients with hallucinations and delusions associated with Parkinson's disease psychosis. Up to 60 % of patients with ...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-016-0597-9

    authors: Markham A

    更新日期:2016-07-01 00:00:00

  • Protein binding displacement interactions and their clinical importance.

    abstract::The binding of drugs to proteins is an important pharmacokinetic parameter. Many methods are available for the study of drug protein binding phenomena and there are also many ways to interpret the binding data. Although much emphasis has been placed on the binding of drugs in the plasma, binding also takes place in th...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/00003495-198325050-00003

    authors: McElnay JC,D'Arcy PF

    更新日期:1983-05-01 00:00:00

  • Myocardial infarction. Secondary prevention with nifedipine.

    abstract::The rationale for the use of nifedipine in patients with acute myocardial infarction (MI) is based on the various cardiovascular actions of the compound: reduction of myocardial oxygen consumption by attenuation of cardiac and vascular smooth muscle tension; augmentation of oxygen and substrate supply after increased ...

    journal_title:Drugs

    pub_type: 临床试验,杂志文章,随机对照试验,评审

    doi:10.2165/00003495-199100422-00007

    authors: Rafflenbeul W,Ebner F

    更新日期:1991-01-01 00:00:00

  • Aripiprazole: a review of its use in the management of mania in adults with bipolar I disorder.

    abstract::Aripiprazole (Abilify®) is an atypical antipsychotic indicated for the treatment of mania associated with bipolar I disorder. It is unique in its class, as it is a partial agonist of dopamine D(2) and D(3), and serotonin 5-HT(1A) receptors and a modest antagonist of 5-HT(2A) receptors. This article reviews the pharmac...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.2165/11208320-000000000-00000

    authors: Dhillon S

    更新日期:2012-01-01 00:00:00

  • Systemic glucocorticoid therapy: a review of its metabolic and cardiovascular adverse events.

    abstract::The prevalence of use of long-term systemic glucocorticoid therapy in the general adult population is 1 %. This figure increases to up to 3 % in elderly women. Metabolic (i.e. diabetes mellitus, dyslipidemia, weight gain, lipodystrophy) and cardiovascular (i.e. hypertension, cardiovascular events) adverse events are c...

    journal_title:Drugs

    pub_type: 杂志文章,评审

    doi:10.1007/s40265-014-0282-9

    authors: Fardet L,Fève B

    更新日期:2014-10-01 00:00:00