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市場調査レポート

米国のバイオシミラー市場参入

Biosimilars Market Access in the U.S.

発行 Datamonitor Healthcare 商品コード 365159
出版日 ページ情報 英文 113 Pages
納期: 即日から翌営業日
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米国のバイオシミラー市場参入 Biosimilars Market Access in the U.S.
出版日: 2017年03月23日 ページ情報: 英文 113 Pages
概要

当レポートでは、米国のバイオシミラー市場について調査分析し、必要性、規制環境、政策、法的問題、価格、償還、参入など、体系的な情報を提供しています。

エグゼクティブサマリー

バイオシミラーの必要性

  • バイオシミラーとは
  • バイオシミラーの規制プロセスの策定において、米国はEUに遅れを取っている
  • バイオシミラーは、米国の医療制度に大幅なコスト削減を提供すると期待されている
  • バイオシミラーには、対処すべきいくつかの質問がある
  • 参考文献

規制経路

  • Omnitrope
  • Basaglar
  • BPCI法
  • FDAがバイオシミラーの承認に関する指針を発表
  • 米国の規制には依然として不確実性がある
  • 適応外挿
  • 米国とEUの承認プロセスには、いくつかの違いがある
  • Zarxioは、BPCI法によって承認された最初のバイオシミラー
  • その後に米国で承認された3つのバイオシミラー:Inflectra、Erelzi、Amjevita
  • 参考文献

代替政策、命名方針

  • バイオシミラーの命名は、議論の余地がある問題
  • バイオシミラーのラベリングは、Zarxioの重要問題 (最新の承認では解決済み)
  • 代替政策は、州によって異なる可能性が高い
  • 参考文献

法的問題

  • 革新的な産業圧力団体が、生物製剤の長期間の独占権を確保
  • 生物製剤は、現在4年間のデータ独占権、8年間の市場優先権を有す
  • 多数の発案者によって、特許訴訟が進行中
  • 参考文献

価格、償還、参入

  • 生物製剤の支出の管理には、異なるツールが使用される
  • バイオシミラーは、ブランドと比較して、少なくとも20%割引を提供する
  • バイオシミラーの使用は、数多くの対策によって促進される
  • 支払人によるバイオシミラー使用の促進は、適応によって異なる
  • 支払人は、バイオシミラーをブランドとして扱う
  • ACOとGPOが、バイオシミラーの使用に関心を持つ
  • 参考文献

教育、通信の必要性

  • 多くのステークホルダーの目には、バイオシミラーに関する不確実性がまだ残っている
  • 医師の大部分はバイオシミラーについて懸念を持っていたが、認識が変化している
  • 患者はバイオシミラーを受け入れる可能性がある
  • バイオシミラーの教育が米国で不可欠である
  • バイオシミラーの受け入れと使用を促進するために、合同での教育努力が必要
  • 参考文献

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目次
Product Code: DMKC0170737

The route to a formal US regulatory pathway for biosimilar approval was established with the creation of the Biologics Price Competition and Innovation Act of 2010.

However, it took five more years for the first biosimilar to be launched in the US through this pathway, namely Zarxio. The US Food and Drug Administration (FDA) has since approved three additional biosimilars - Inflectra, Erelzi, and Amjevita - but of these three, only Inflectra has been launched to date. Despite the presence of this regulatory pathway and accompanying FDA guidance documents for the pharmaceutical industry to ensure consistent approaches to clinical trials, similarity, and interchangeability, there are still many unanswered questions which are likely to have an impact on the launch and uptake of biosimilars over the next few years.

A number of regulatory uncertainties exist that require clarification in order for the US biosimilars market to be fully realized. These uncertainties include questions on labeling, substitution, and interchangeability. In addition to the regulatory questions, there are also a number of legal issues that are yet to be resolved and which may have a significant impact on the future approval and launch of biosimilars in the US. The most important of these involve the 180-day launch notification period and the patent dance provisions, both of which will be argued in front of the US Supreme Court during 2017. Once these regulatory and legal hurdles are overcome, it is anticipated that there will be few, if any, major obstacles to market access, with access expected to be relatively straightforward due to the cost benefits that biosimilars offer. Physician reluctance to use biosimilars interchangeably with the original product may prove to be an issue, albeit one that can be overcome with education efforts.

Table of Contents

EXECUTIVE SUMMARY

  • Regulatory pathway
  • Substitution and naming
  • Legal considerations
  • Pricing, reimbursement, and access
  • Education needs

THE NEED FOR BIOSIMILARS

  • What are biosimilars?
  • The US has lagged behind the EU in developing a regulatory process for biosimilars
  • Biosimilars are expected to deliver considerable cost savings for the US healthcare system
  • There are several questions around biosimilars that need to be addressed
  • Bibliography

REGULATORY PATHWAY

  • Omnitrope was a "copy" biologic that was approved prior to 2010 via the 505(b)(2) process
  • Basaglar was the second "copy" biologic approved in the US through the 505(b)(2) pathway
  • The BPCI Act established a dedicated biosimilar approval pathway in the US
  • The FDA has released guidance on biosimilar approval requirements
  • There are still several uncertainties around the regulatory pathway in the US
  • Indication extrapolation poses the greatest regulatory uncertainty for manufacturers
  • There are several key differences in US and EU approval processes
  • Zarxio was the first biosimilar to be approved through the BPCI Act pathway
  • Three more US biosimilars have since been approved: Inflectra, Erelzi, and Amjevita
  • Bibliography

SUBSTITUTION AND NAMING POLICY

  • Biosimilars naming is a contentious issue
  • Biosimilar labeling was a key issue with Zarxio, but seems to have been resolved with the newest approvals
  • Substitution policies are likely to vary across states
  • Bibliography

LEGAL ISSUES

  • The innovative industry lobby secured a long period of exclusivity for biologics
  • Biologics currently have four years of data exclusivity followed by eight years of market exclusivity
  • Patent litigation is being pursued by many originator companies
  • Bibliography

PRICING, REIMBURSEMENT, AND ACCESS

  • Different tools are used to control spending on biologics
  • Biosimilars are expected to offer at least 20% discounts relative to the brand
  • Biosimilar use will be driven by a number of measures
  • Payers' drive to promote biosimilar use depends on the indication
  • Payers will treat biosimilars as brands
  • Accountable care organizations and group purchasing organizations will have an interest in using biosimilars
  • Bibliography

EDUCATION AND COMMUNICATION NEEDS

  • There are still residual uncertainties regarding biosimilars in the eyes of many stakeholders
  • A large proportion of physicians have had concerns about biosimilars, but perceptions are changing
  • Patients likely to accept biosimilars
  • Education around biosimilars is critical for access and uptake in the US
  • Concerted education efforts are required in order to boost biosimilar acceptance and use
  • Bibliography

LIST OF FIGURES

  • Figure 1: Definitions of various types of biologics and copy products
  • Figure 2: Key events in the evolution of regulatory environments for biosimilars
  • Figure 3: Approval pathways available for biologics in the US
  • Figure 4: Information exchange steps between biosimilars manufacturers and reference product patent holders
  • Figure 5: Biosimilars reimbursement under Medicare Part B
  • Figure 6: US healthcare professionals' understanding of biosimilars
  • Figure 7: Key organizations involved in stakeholder education about biosimilars

LIST OF TABLES

  • Table 1: Key US biosimilar regulatory events
  • Table 2: Committees created to support biosimilar approval
  • Table 3: FDA guidance on biosimilars published to date
  • Table 4: Key scientific principles used for biosimilar application review
  • Table 5: FDA interchangeability requirements for biosimilars
  • Table 6: Regulatory considerations for indication extrapolation for biosimilars
  • Table 7: Factors influencing physician acceptability and likelihood of indication extrapolation
  • Table 8: Differences in US and EU biosimilar definitions, regulatory guidance, and other key regulatory factors influencing biosimilar approval and use
  • Table 9: Biosimilar substitution: select state laws and legislation
  • Table 10: Key features of the BPCI Act
  • Table 11: Data, market exclusivity, and patent expiry dates in the US for selected biologics
  • Table 12: Summary of ongoing legal challenges
  • Table 13: Utilization tools for the management of biologics spending
  • Table 14: Utilization tools applied to biosimilars
  • Table 15: Payer strategies aimed at increasing biosimilar uptake will vary by indication and product characteristics
  • Table 16: Prior authorization criteria from major health insurers for Neupogen
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