The role of biosimilars in value-based oncology care

Patel, Karan; Arantes, Luiz H.; Tang, Wing Yu; Fung, Selwyn

doi:10.2147/cmar.s164201

Cited by 34 publications

(42 citation statements)

References 51 publications

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“…The EU approved the first biosimilar biosimilar in 2015, filgrastim (Zarxio ® ), almost a decade later than the somatropin (Omnitrope ® ) in 2006, which was followed by the approval of many more (11). Up until 2018, 35 biosimilars have entered the European market, whereas only seven have been licensed in the USA (6). The USA approved the first biosimilar filgrastim (Zarxio ® ) in 2015, almost a decade later than the EU and the next one was approved on 2018 (Neupogen ® ); however, more are expected to enter the market within the next 2 years (6).…”

Section: Biologics and Biosimilarsmentioning

confidence: 99%

“…Up until 2018, 35 biosimilars have entered the European market, whereas only seven have been licensed in the USA (6). The USA approved the first biosimilar filgrastim (Zarxio ® ) in 2015, almost a decade later than the EU and the next one was approved on 2018 (Neupogen ® ); however, more are expected to enter the market within the next 2 years (6).…”

Section: Biologics and Biosimilarsmentioning

confidence: 99%

“…Biologics account for half of the pharmacological market in oncology; however, their main drawback is their high cost (5). As patents of these biologics began to expire, biosimilars were developed in order to address the existing needs and facilitate access to novel treatments for all patients (6). As compared with biologics, biosimilars are generally cheaper and more affordable; therefore, they have the potential to significantly reduce healthcare costs (7).…”

Section: Introductionmentioning

confidence: 99%

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Current and future roles of biosimilars in oncology practice (Review)

2019

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Biologics have been used increasingly in the treatment and supportive care of cancer; however, their high cost places a significant burden on healthcare systems. The expiration of patents for biologics has led to the development of biosimilars, with the aim of reducing cost and increasing accessibility to novel treatments, which are affordable for a greater number of patients. Biosimilars are highly similar but not identical to the reference products; therefore, strict regulatory requirements have been formed for their approval. This ensures that there are no clinically meaningful differences compared with respective biologics, with regard to purity, safety and efficacy. In 2003, a regulatory framework for the approval of biosimilars was established in Europe, whereas the USA did not implement a framework until 2009, when the Biologics Price Competition and Innovation Act was formed. A number of biosimilars have currently been approved in oncology and the number is expected to rise in the near future. More than 10 years of evidence has revealed that biosimilars are safe and effective; however healthcare professionals need to be further educated to eliminate potential misconceptions and integrate biosimilars into routine clinical practice. The present review aims to provide an overview of the biosimilars used in Europe and the USA, present their main benefits and challenges, and discuss their current and future roles in medical oncology.

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Section: Biologics and Biosimilarsmentioning

confidence: 99%

Section: Biologics and Biosimilarsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Current and future roles of biosimilars in oncology practice (Review)

2019

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“…Given the grave impact of oncology drug shortages, including increased burden of time to deal with the shortage and potentially increased drug costs and, in some cases, elevated risk of medication errors, a reliable supply of high-quality biosimilars is critical for pharmacy operations and delivery of patient care [42]. At this time, it is not known whether biosimilars will provide any cost savings in the US similar to what has been observed in Europe and other global regions [43]. However, it is expected that the expanded treatment choices provided by the availability of biosimilars may favorably impact the overall value-based delivery of care.…”

Section: Other Considerationsmentioning

confidence: 99%

Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab

Kolberg

Colleoni

Santi³

et al. 2019

Targ Oncol

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ABP 980 was developed as a biosimilar to trastuzumab, a monoclonal antibody targeting human epidermal growth factor receptor 2 (HER2), that is indicated for the treatment of HER2-positive metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer. ABP 980 is approved in the United States, European Union, and Japan for all the indications of trastuzumab, based on the totality of evidence (TOE) gathered by the systematic step-wise accumulation of comparative analytical, preclinical, and clinical (pharmacokinetics [PK], efficacy, safety and immunogenicity) data for ABP 980 and trastuzumab reference product (RP). As a key first step of the ABP 980 biosimilar program, comprehensive analytical characterization of critical quality attributes established that ABP 980 is structurally and functionally similar to trastuzumab RP. Complementing these data, results of non-clinical pharmacology, toxicology, and toxicokinetic studies supported similarity between ABP 980 and trastuzumab RP. A randomized study in healthy subjects demonstrated clinical PK equivalence of ABP 980 relative to trastuzumab RP in these subjects. In the final clinical evaluation step, a randomized comparative study (LILAC) confirmed the lack of clinically meaningful differences between ABP 980 and trastuzumab RP in efficacy, safety, and immunogenicity in women with HER2-positive EBC in the neoadjuvant-adjuvant setting. Neoadjuvant EBC represented a sensitive homogenous population for biosimilar demonstrations, and the primary endpoint of pathologic complete response served as a sensitive surrogate endpoint. An important aspect of the LILAC study design is that it is the only study that evaluated the effect of switching from the trastuzumab RP to a trastuzumab biosimilar during the adjuvant phase. No new or unexpected safety signals emerged in the clinical evaluations, with the safety profile of ABP 980 consistent with that previously described for trastuzumab. Overall, the TOE data generated for ABP 980 support the conclusion that it is highly similar to trastuzumab RP, thus providing the scientific justification for extrapolation to all the approved indications of trastuzumab.

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“…As biosimilars offer the potential for lower acquisition costs versus the originator biologic, evaluating the economic implications of the introduction of biosimilars is of interest [2]. As the costs of biologics are high, biosimilars offer the potential of greater choice and value, increased patient access to treatment, and the potential for improved outcomes [3]. By providing more-affordable treatment options and introducing price competition to the market, biosimilar medicines can generate significant savings.…”

Section: Introductionmentioning

confidence: 99%

Safety Issues of Biosimilar Products

Mohiuddin¹

2016

ACT

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Biosimilars are not expected to be direct copies of biologic medicines and are therefore not the same as generic drugs. Due to the complex structure of biologic medicines and the processes involved in production, biosimilars must be shown on the basis of analytical, non-clinical and clinical data to be similar to an original biologic in terms of structural characteristics, and safety and efficacy. Minor differences with the active ingredient are expected and permitted so long as any such differences are demonstrated not to be clinically meaningful. In 2012, 7% of worldwide sales (US $53 billion) were at risk as a result of the free entry of generic drugs, which compete directly with the original brands, forcing them to lower their prices or, even worse, to stop producing them. By 2020, it is expected that this loss of profitability will reach US $259 billion. This is clear that biosimilars impose some goods in terms of availability and affordability but surely a discourage to invention of newer biotech products in future.

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The role of biosimilars in value-based oncology care

Cited by 34 publications

References 51 publications

Current and future roles of biosimilars in oncology practice (Review)

Current and future roles of biosimilars in oncology practice (Review)

Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab

Safety Issues of Biosimilar Products

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