The Ecstacy of Gold: Patent Expirations for Trastuzumab, Bevacizumab, Rituximab, and Cetuximab

Serna-Gallegos, Tasha; Lafargue, Christopher J.; Tewari, Krishnansu S.

doi:10.2174/1872208311666171122152131

Cited by 12 publications

(7 citation statements)

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“…Similar disparities are also seen in LMICs in different parts of the world. In a RWD study from China, patients with early stage breast cancer in resource-abundant regions were more likely to receive trastuzumab than those in resource-limited regions (37% versus 13%, p < 0.05) [41]. Similarly, an observational study of Chinese patients with HER2+ tumours reported that 27% of those with advanced disease did not receive trastuzumab at any time after diagnosis and 49% did not receive trastuzumab in the first-line setting [14].…”

Section: Barriers To the Incorporation Of New Therapies For Advanced mentioning

confidence: 99%

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Access to high-cost drugs for advanced breast cancer in Latin America, particularly trastuzumab

Barrios¹,

Reinert²,

Werutsky³

2019

ecancer

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Provision of high-level healthcare is a challenge for all low- to middle-income countries (LMICs) since healthcare systems are heterogeneous, face many challenges such as inadequate funding, inequitable distribution of resources and services and usually are not adequately equipped to deal with a huge problem such as breast cancer. The development of anti-HER2 therapies can be considered one of the most important examples of the translation of molecular biology knowledge into clinical benefits for cancer patients. While a variety of novel therapeutic strategies are emerging, current treatment regimens remain focussed on targeted therapy with monoclonal antibodies, mainly trastuzumab, the first agent developed in this field. While these results have revolutionised the outcome of HER2+ patients in clinical trials and in high-income countries where they are widely available, results have not impacted the natural history of this aggressive disease in most of the world. Unfortunately, the availability of these drugs is far from universal in many LMICs, and in Latin America, in particular, patients with HER2+ breast cancer are treated exclusively with standard chemotherapy, a more toxic and less efficient therapy. While the complexity of the situation and the multiple factors that have an impact in this scenario are recognised, we need to map the future and develop feasible strategies to address possible solutions to the problem of drug access. A clear and unbiased diagnosis of the situation is a good starting point. Defining healthcare priorities and a clear strategy for the allocation of resources is difficult but mandatory. In this article, we will discuss current and future challenges regarding access (and lack of access) to high-cost cancer drugs in Latin America, with a focus on anti-HER2 therapies.

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Section: Barriers To the Incorporation Of New Therapies For Advanced mentioning

confidence: 99%

“…Patents for several biologic drugs, including trastuzumab, have recently expired or will soon expire, which has stimulated the development of biosimilars [41]. Several countries have implemented abbreviated pathways for approval of biosimilars.…”

Section: Moving Forwardmentioning

confidence: 99%

Access to high-cost drugs for advanced breast cancer in Latin America, particularly trastuzumab

Barrios¹,

Reinert²,

Werutsky³

2019

ecancer

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“…17,24,29,30 Trastuzumab referans ürününün patentleri Avrupa Birliği (AB) ve ABD'de (sırasıyla 2014 ve 2019) kısa süre önce sona ermiştir. [31][32][33] Bunla birlikte alternatif olarak firmalar biyobenzer ilaç geliştirme çalışmalarını hızlandırmışlardır.34 Meme kanseri için insan epidermal büyüme faktörü reseptörü 2 (HER2) pozitifliği yüksek dereceli histoloji, lenf nodu tutulumu, daha yüksek hastalık nüksetmesi ve mortalite oranları ile ilişkisi nedeniyle kötü prognoz çerçevesi oluşturmaktadır.3 5 Meme kanserine karşı bir monoklonal antikor olan trastuzumab (Herceptin Roche / Genentech GmbH), bu hastalığın doğal seyrini değiştiren ve HER2 proteinini hedefleyen etkili bir ilaçtır. 5,35,36 Trastuzumab biyobenzerinin yanı sıra tedavide, tümör anjiyogenezini bloke edebilen bevacizumab(vasküler endotelyal büyüme faktörünü bağlayan bir monoklonal antikor -VEGF)da kulanılmaktadır.…”

Section: Biyobenzerlerin öNemiunclassified

Biyobenzer İlaçlar

KÜÇÜK

Duru

Mutlu

et al. 2021

Beykent Üniversitesi Fen Ve Mühendislik Bilimleri Dergisi

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Biyobenzer ilaçlar, saflık, güvenlik ve etkinlik açısından referans kaynağından klinik olarak anlamlı farklılıklara sahip olmayan lisanslı biyolojiklere (referans biyolojikler) oldukça benzer olduğu gösterilen biyolojikler olarak tanımlanmaktadır. Biyobenzerler, biyolojik kaynaklı ilaçlarla tedavisi olan hastalıklar açısından alternatif ilaçlar olarak üretilmektedir. Bu sayede kanser gibi spesifik hastalıklara yönelik tedaviler çeşitlilik kazanmaktadır. Örneğin meme kanseri için kullanılan biyobenzerler geliştirildikçe gelecekte bu hastalığın tedavilerine erişilebilirlik artacaktır ve bu gelişmeler de anti-HER2 ve anti-VEGF tedavisinin daha yaygın kullanımına olanak sağlayacaktır. Meme kanseri tedavisinde kullanılan Trastuzumab için, Avrupa patenti 2014'te, ABD patenti 2019'da sona ermiştir. Patent sürelerinin dolması bu biyobenzer ilaçların geliştirilmesini hızlandırmıştır. Bu derlemede öncelikle biyobenzerler hakkında genel bilgiler aktarılmış ve Göğüs/Meme kanseri için kullanılan biyobenzerler hakkında ayrıntılı tartışma gerçekleştirilmiştir.

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“…In addition, monoclonal antibodies such as cetuximab and trastuzumab that target growth receptors overexpressed by cancer cells are used in both first and second line treatment regimens for common malignancies [ 7 ]. Despite the reported clinical benefits of targeted monoclonal antibodies, such as trastuzumab, and continued clinical use, the majority of patients develop therapeutic resistance that remains poorly understood [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

Overcoming malignant cell-based mechanisms of resistance to immune checkpoint blockade antibodies

Ajina

Zahavi

Zhang

et al. 2020

Seminars in Cancer Biology

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Traditional cancer treatment approaches have focused on surgery, radiation therapy, and cytotoxic chemotherapy. However, with rare exceptions, metastatic cancers were considered to be incurable by traditional therapy. Over the past 20 years a fourth modality -immunotherapy -has emerged as a potentially curative approach for patients with advanced metastatic cancer. However, in many patients cancer "finds a way" to evade the anti-tumor effects of immunotherapy. Immunotherapy resistance mechanisms can be employed by both cancer cells and the non-cancer elements of tumor microenvironment. This review focuses on the resistance mechanisms that are specifically mediated by cancer cells. In order to extend the impact of immunotherapy to more patients and across all cancer types, and to inhibit the development of acquired resistance, the underlying biology driving immune escape needs to be better understood. Elucidating mechanisms of immune escape may shed light on new therapeutic targets, and lead to successful combination therapeutic strategies.

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The Ecstacy of Gold: Patent Expirations for Trastuzumab, Bevacizumab, Rituximab, and Cetuximab

Cited by 12 publications

References 0 publications

Access to high-cost drugs for advanced breast cancer in Latin America, particularly trastuzumab

Access to high-cost drugs for advanced breast cancer in Latin America, particularly trastuzumab

Biyobenzer İlaçlar

Overcoming malignant cell-based mechanisms of resistance to immune checkpoint blockade antibodies

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