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Biosimilars Market Access in the U.S.

  • ID: 4238715
  • Report
  • March 2017
  • Region: United States
  • 113 pages
  • Datamonitor Healthcare
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.
Note: Product cover images may vary from those shown
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

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

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

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

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

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

8. 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

9. 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
Note: Product cover images may vary from those shown