Biosimilars in oncology: Effects on economy and therapeutic innovations

Hübel, Kai; Kron, Florian; Lux, Michael P.

doi:10.1016/j.ejca.2020.07.037

Cited by 22 publications

(12 citation statements)

References 21 publications

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“…Biosimilars play a key role in reducing healthcare costs and improving patient access to life-saving therapies [ 6 ]. Results from a previous study have suggested that the use of trastuzumab biosimilars compared with originator trastuzumab may lead to annual cost savings in the range of 96 to 120 million euros (~ 11%) in a country like Germany [ 23 ]. The long-term data presented here further support trastuzumab-dkst as a valuable part of the growing biosimilar market that includes 4 other trastuzumab biosimilars approved by the FDA and EMA in recent years [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer

Rugo

Pennella

Gopalakrishnan³

et al. 2021

Breast Cancer Res Treat

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Purpose The phase 3 HERITAGE trial demonstrated that the biosimilar trastuzumab-dkst is well tolerated with similar efficacy (measured by overall response rate [ORR] and progression-free survival [PFS]) compared with originator trastuzumab combined with taxane followed by monotherapy in patients with HER2-positive metastatic breast cancer (MBC). Herein, we present final overall survival (OS) from HERITAGE. Methods HERITAGE is a multicenter, double-blind, randomized, parallel-group study. Patients were randomized 1:1 to receive trastuzumab-dkst or trastuzumab plus taxane followed by continued monotherapy until disease progression. Overall survival was to be assessed at 36 months or after 240 deaths, whichever occurred first, as observed from time of randomization of last patient. Results At the final analysis (36 months), 242 patients in the intention-to-treat population had died during the study: 116 and 124 in the trastuzumab-dkst and trastuzumab groups, respectively, and 1 untreated patient from each treatment group. Median OS by Kaplan–Meier analysis was 35.0 months with trastuzumab-dkst and 30.2 months with trastuzumab. Evaluation of PFS showed a median of 11.1 months in both treatment groups. No new safety concerns were reported from week 48 until the end of the survival follow-up. Conclusion This is the first phase 3 trial of a trastuzumab biosimilar to report long-term survival data similar to originator trastuzumab in patients with MBC. The comparable long-term OS between the trastuzumab-dkst and originator trastuzumab groups further supports the similarity of trastuzumab-dkst with originator trastuzumab and establishes trastuzumab-dkst as a safe and effective treatment option for patients with HER2-positive MBC. ClinicalTrials.gov NCT02472964; 6/16/2015

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Section: Discussionmentioning

confidence: 99%

Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer

Rugo

Pennella

Gopalakrishnan³

et al. 2021

Breast Cancer Res Treat

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“…Having transformed certain advanced cancer into manageable chronic diseases, the success of antibody therapy has also added to the costs for healthcare systems. To make it more affordable, real-world health economic analyses indicate that application of biosimilars could save from 4.9 to 120 million Euros for each antibody treatment including Rituximab and Trastuzumab [ 28 ] .…”

Section: Evaluation Of Economic Benefitsmentioning

confidence: 99%

Real-world studies: bridging the gap between trial-assessed efficacy and routine care

Chen¹

2022

J Biomed Res

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Even though randomized controlled clinical trials (RCTs) have been accepted as the gold standard for official assessment of novel interventions, there is a substantial gap between the efficacy observed in RCTs and the impact on clinical practice and in terms of patient benefit. While real-world studies (RWS) are emerging to confer valuable complementing evidence in this regard and beyond, the evolving role of RWS is yet to be agreed. This article delineates an updated profile of RWS covering effectiveness verification, rare adverse effects discovery, indication repurposing, to name a few. RWS tends not only to improve the efficiency of clinical investigations for regulatory approval, but also optimizes the whole-life cycle evaluation of biomedical/pharmaceutical products.

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“…Similarly prospective annual reductions for filgrastim was 40.5 million euros, for pegfilgrastim 56.4 million euros and likewise within 95.9 and 120.5 million euros in the case of trastuzumab. 53 Transforming to multidose vials from single-dose vials has been estimated to retain an additional 59.5 million euros. 54 In another study conducted at Ministry of National Guard Health Affairs, Saudi Arabia, it was depicted that the use of filgrastim biosimilar has showed notable cost reduction annually.…”

Section: Overview Of Economic Impact and Financial Savings From Biosimilar Utilizationmentioning

confidence: 99%

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

Safdar

Butt

Ahmad

et al. 2021

J Oncol Pharm Pract

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Stupendous elevation in the healthcare costs has followed with the inception of the current unconventional options of treatment available for cancer patients. There is a dire need of innovative financing approaches to lessen the financial load on healthcare system. Biosimilars are biological drugs consisting of an active ingredient from a reference biological drug that has a great potential of relieving financial load. Strict requirements from regulatory point of view are required as biosimilars are exceedingly similar to but not identical to the reference product. This provides with a certainty that no consequential differences from clinical point of view as compared to the respective biologics exists with regards to efficacy, safety and purity. Safety and effectiveness of biosimilars have been disclosed since more than 10 years of affirmations. However, there is a need to educate the healthcare professionals to abolish potential misconceptions and coalesce biosimilars into regular clinical practice. The present review focuses on providing an overview of regulatory aspects and requirements for biosimilars, the main challenges in the selection and development of biosimilars and the economic impact and financial savings observed in recent studies carried out in different parts of the world. In addition, we have discussed the different successful comparative studies which have been done in different parts of the world to depict the biosimilarity for monoclonal antibodies such as bevacizumab, trastuzumab and rituximab.

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Biosimilars in oncology: Effects on economy and therapeutic innovations

Cited by 22 publications

References 21 publications

Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer

Final overall survival analysis of the phase 3 HERITAGE study demonstrates equivalence of trastuzumab-dkst to trastuzumab in HER2-positive metastatic breast cancer

Real-world studies: bridging the gap between trial-assessed efficacy and routine care

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

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