Track topics on Twitter Track topics that are important to you
This article provides an updated review of the biosimilar medicines approved for cancer therapy in the European Union (EU). First we discuss the most relevant aspects for the development and approval of biosimilar medicines. We then present the oncological biosimilar drugs currently used, which include epoetins (alpha and zeta), filgrastim, and monoclonal antibodies (rituximab, trastuzumab and bevacizumab). Among the clinical applications of biosimilar medicines, cancer therapy remains the main target area and more approved biosimilars are expected over the next few years, providing cost-effective drugs to more patients. Furthermore, comprehensive pharmacovigilance studies are going on, monitoring the marketed biosimilars, and providing more feasible information to clinicians regarding the safety and efficacy of these medications.
This article was published in the following journal.
Name: Drug discovery today
Biosimilars are highly similar copies of previously approved original biologic medicines. Their introduction on the market may yield cost reduction. The aim of this study was to evaluate the perspect...
While lung cancer screening has been implemented in the United States, it is still under consideration in Europe. So far, lung cancer screening trials in Europe were not able to replicate the results ...
There is evidence that it is safe and effective for patients with inflammatory bowel diseases (IBD) to switch from maintenance therapy with an original infliximab drug to a biosimilar, but little is k...
Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007.
Breast cancer is known as a most prevalent cancer and second deadly cancer, among women worldwide. Due to the high incidence rate of breast cancer and limitations of conventional therapy it seemed ess...
In Canada and worldwide there is a need for updated independent real-world comparative effectiveness and safety data related to biologic drugs including biosimilar drugs. Biosimilar drugs ...
Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patie...
Multicentre, randomised (1:1), controlled, open (not blinded) comparison of MOR toolkit (intervention) with standard pharmaceutical care (control)
Study to Investigate the Efficacy and Safety of Trastuzumab Biosimilar (Herzuma®) Plus Treatment of Physician's Choice (TPC) in Patients With HER-2 Positive Metastatic Breast Cancer Who Progressed After 2 or More HER-2 Directed Chemotherapy
Trastuzumab combined with chemotherapy has been approved as the first line therapy in HER2+ metastatic breast cancer. When patients experienced progression beyond trastuzumab containing th...
The purpose of this multicentre, randomized, double blinded, single dose, two-way cross-over study, is to compare the pharmacokinetics (PK) of biosimilar eptacog alfa (activated) with Novo...
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
A performance measure for rating the ability of a person to perform usual activities, evaluating a patient's progress after a therapeutic procedure, and determining a patient's suitability for therapy. It is used most commonly in the prognosis of cancer therapy, usually after chemotherapy and customarily administered before and after therapy. It was named for Dr. David A. Karnofsky, an American specialist in cancer chemotherapy.
Review of the medical necessity of hospital or other health facility admissions, upon or within a short time following an admission, and periodic review of services provided during the course of treatment.
Formal programs for assessing drug prescription against some standard. Drug utilization review may consider clinical appropriateness, cost effectiveness, and, in some cases, outcomes. Review is usually retrospective, but some analysis may be done before drugs are dispensed (as in computer systems which advise physicians when prescriptions are entered). Drug utilization review is mandated for Medicaid programs beginning in 1993.
Organizations representing designated geographic areas which have contracts under the PRO program to review the medical necessity, appropriateness, quality, and cost-effectiveness of care received by Medicare beneficiaries. Peer Review Improvement Act, PL 97-248, 1982.
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...