A clinician’s guide to biosimilars in oncology

Rugo, Hope S.; Linton, Kim; Cervi, Paul; Rosenberg, J.; Jacobs, Ira

doi:10.1016/j.ctrv.2016.04.003

Cited by 80 publications

(98 citation statements)

References 36 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Regulatory authorities have not provided a definitive battery of analyses that need to be conducted, and each potential biosimilar is developed and approved on an individual basis. Biosimilar approval is granted on evaluation of the totality of evidence, encompassing the comparative analytical, nonclinical, pharmacokinetic (PK)/PD and clinical data [46,47]. Thus, the development pathway and requirements for approval for biosimilars differ from those of new biologic medicines, and from those for generic versions of chemically synthesized smallmolecule drugs ( Figure 1).…”

Section: Demonstrating Biosimilaritymentioning

confidence: 99%

Bevacizumab Biosimilars: Scientific Justification for Extrapolation of Indications

et al. 2018

Self Cite

View full text Add to dashboard Cite

The first biosimilar of bevacizumab was approved by the US FDA; other potential biosimilars of bevacizumab are in late-stage clinical development. Their availability offers opportunity for increased patient access across a number of oncologic indications. The regulatory pathway for biosimilar approval relies on the totality of evidence that includes a comprehensive analytical assessment, and a clinical comparability study in a relevant disease patient population. Extrapolation of indications for a biosimilar to other eligible indications held by the originator, in the absence of direct clinical comparison, frequently forms part of the regulatory judgment. Herein, we consider the evidence required to demonstrate biosimilarity for bevacizumab biosimilars, with particular focus on the rationale for extrapolation across oncologic indications. Bevacizumab (Avastin R ; Roche, Welwyn Garden City, UK; Genentech, CA, USA) is a monoclonal antibody directed against VEGF. It is approved in Europe and the USA for the treatment of a range of cancers, including metastatic or recurrent nonsquamous non-small-cell lung cancer (NSCLC), metastatic renal cell carcinoma, metastatic colorectal cancer (CRC), cervical cancer, and platinum-resistant or platinum-sensitive recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers [1,2]. In addition, in the USA, Japan, and many other countries, bevacizumab is indicated for the treatment of patients with glioblastoma. In Europe, it is also authorized for use in metastatic breast cancer and in combination with erlotinib for the first-line treatment of advanced, metastatic nonsquamous NSCLC with EGF receptor-activating mutations [3]. Randomized Phase III trials have shown that progression-free survival (PFS) and/or overall survival (OS) in patients with these cancers is prolonged with treatment combining bevacizumab with standard chemotherapy (Table 1) [4][5][6][7][8][9][10][11][12]. Nonetheless, patient access to bevacizumab may be limited.Barriers to bevacizumab use stem from factors such as insurance coverage and cost of treatment, manufacturing and supply and uncertainty as to its cost-effectiveness in some clinical settings [13][14][15]. A survey conducted by the European Society of Medical Oncology Consortium found budget constraints, affordability and issues related to the manufacture and assured supply of the product were cited most frequently as reasons for access to bevacizumab to be considered suboptimal [13]. Oncologists who were surveyed in the USA, Europe and in some emerging market countries (Brazil, Mexico and Turkey) stated the major barriers to prescribing bevacizumab were the high out-of-pocket costs for patients and a lack of reimbursement. These barriers were commonly cited as reasons for reducing the number of drug treatment cycles that were planned for patients [15].Protein-based biologics, such as bevacizumab, are produced in living cells rather than by chemical synthesis, and are large and structurally complex [16]. Their structure and activity are in...

show abstract

Section: Demonstrating Biosimilaritymentioning

confidence: 99%

Bevacizumab Biosimilars: Scientific Justification for Extrapolation of Indications

et al. 2018

Self Cite

View full text Add to dashboard Cite

show abstract

“…86 However, the recent or imminent expiry of patents and exclusivity for several anti-cancer mAbs has instigated the global development of numerous biosimilars of these therapies, principally bevacizumab, rituximab, and trastuzumab. 1 Bevacizumab is an inhibitor of vascular endothelial growth factor and is indicated for the treatment of an array of tumor types, including metastatic colorectal cancer, metastatic breast cancer, non-small-cell lung cancer, and metastatic renal cell carcinoma. Rituximab targets CD20 and is used in the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia, as well as RA and other conditions.…”

Section: Biosimilar Monoclonal Antibody Therapies Relevant To Oncologmentioning

confidence: 99%

“…Since their introduction, biologics have had a substantial impact on the clinical management of various cancers and systemic inflammatory conditions such as rheumatoid arthritis (RA), inflammatory bowel diseases (IBD), psoriasis, and psoriatic arthritis. 1 –4 However, patient access to such biologics can be limited or subject to inequity, and improving access to these highly effective treatments remains an unmet need in many countries. 5–8 Barriers to access include treatment protocols or guidelines not permitting use; drug availability or supply chain problems; prohibitively high patient out-of-pocket expense; logistical challenges related to attending medical appointments; concerns over the safety and cost-effectiveness of treatment; reimbursement or insurance coverage issues; and, finally, time-consuming paperwork for physicians.…”

Section: Introductionmentioning

confidence: 99%

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Scheinberg

Pineda

Castañeda‐Hernández

et al. 2018

mAbs

Self Cite

View full text Add to dashboard Cite

Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patient access to biologics. In Latin American countries, regulatory frameworks for biosimilar approval have been introduced in recent years, and biosimilars of monoclonal antibody and fusion protein therapies are now emerging. However, the situation in this region is complicated by the presence of “non-comparable biotherapeutics” (also known as “intended copies”), which have not been rigorously compared with the originator product. We review the considerations for clinicians in Latin American countries, focusing on monoclonal antibody biosimilars relevant to oncology, rheumatology, gastroenterology, and dermatology.

show abstract

“…Generic medicines are usually chemically synthesised, allowing the existing medicine to be replicated exactly. 31 Uptake varies between countries in Europe and is influenced by acceptance, brand loyalty among physicians and patients, pharmacist incentives or automatic substitution, patient cost sharing, physician prescription by Potential Solutions for Sustaining the Costs of Cancer Drugs international non-proprietary name and price regulation. 32,33 For example, France has historically been a brand-loyal market with few mechanisms to drive generic uptake, as demonstrated by the low penetration rate.…”

Section: Use Of Less Expensive Medicinesmentioning

confidence: 99%

“…35 A biosimilar is a biologic medicine that matches a licensed reference medicine in terms of safety, purity and potency. 31,[36][37][38][39] There is considerable scope for increasing the use of biosimilar medicines; 40,41 however, demand-side measures and general policies may be needed to change prescribing habits and realise competition in the market with subsequent cost savings.…”

Section: Use Of Less Expensive Medicinesmentioning

confidence: 99%

Potential Solutions for Sustaining the Costs of Cancer Drugs

Lopes¹,

Vulto²,

Wilking³

et al. 2017

European Oncology &Amp; Haematology

View full text Add to dashboard Cite

The growing burden of cancer urgently requires sustainable solutions to ensure continued access to effective and safe treatments for all patients within Europe. The aim of this article, the third in a series of perspectives, is to discuss potential approaches to sustain cancer care and increase patient access to treatments. Much work remains to ensure the sustainability ceiling (where costs of care exceed the benefits) is not reached. Immediate steps must be taken to avoid this, including patient education to encourage earlier diagnosis, use of treatment-response biomarkers, improving efficiency of healthcare systems, use of managed-entry agreements, introduction of value-based medicines with measurable outcomes and use of less expensive medicines. Here we discuss these potential solutions with a focus on reducing the cost of cancer drugs, using biosimilar medicines as an example. Biosimilar and generic medicines offer a cost-effective treatment option that may help combat the substantially increasing costs of cancer drugs. Competition from biosimilar medicines is expected to drive a decrease in the cost of medicines, resulting in increased affordability and access to therapy, and therefore a greater number of patients could be treated. However, various barriers must be overcome to increase the uptake of biosimilar medicines and education is needed to allay misperceptions and encourage greater use.

show abstract

A clinician’s guide to biosimilars in oncology

Cited by 80 publications

References 36 publications

Bevacizumab Biosimilars: Scientific Justification for Extrapolation of Indications

Bevacizumab Biosimilars: Scientific Justification for Extrapolation of Indications

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

Potential Solutions for Sustaining the Costs of Cancer Drugs

Contact Info

Product

Resources

About