Market Overview

United States Biosimilars Market Access Analysis Report 2017: The Need For Biosimilars, Regulatory Pathway, Substitution & Naming Policy, Legal Issues, Pricing Reimbursement & Access


Dublin, May 30, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Biosimilars Market Access in the U.S." report to their offering.

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.

Key Topics Covered:


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


  • 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


  • 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


  • 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


  • 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


  • 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


  • 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

For more information about this report visit

CONTACT: Research and Markets
         Laura Wood, Senior Manager
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         Related Topics: Biosimilars and Biosuperiors

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