Merck & Biosimilars Potential of Biosimilars
MORE CLARITY Clearing a Path to the Latest Information
MORE CLARITY Clearing a Path to the Latest Information

The rules and regulations surrounding biosimilars are evolving rapidly. In order to help you stay up-to-date on some of the most fluid issues, we are providing direct links to the most current information.

PART B REIMBURSEMENT

Currently CMS has said that all biosimilars of a single originator will share the same J-code so that the Average Sales Price (ASP) for each biosimilar will be a blended rate, taking into account the prices of different biosimilar versions.1,2

  • CMS: “Part B Biosimilar Biological Product Payment and Required Modifiers” Learn more
  • CMS: “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2016” Learn more
NAMING

Currently, the FDA states that biosimilar’s nonproprietary names should include a suffix. This will help physicians clearly differentiate among biological medicines.3

  • FDA: “Nonproprietary Naming of Biological Products Guidance for Industry” Learn more
  • Federal Register: “Designation of Official Names and Proper Names for Certain Biological Products” Learn more
INTERCHANGEABILITY

If the FDA rules that a biosimilar is interchangeable, pharmacists in some states may be able to substitute it for the reference product without the intervention of the prescribing health care professional. The guidelines for how a biosimilar might be able to achieve interchangeable status are still in flux.4

  • FDA: “Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009” Learn more
  • National Conference of State Legislature Learn more
References:
1. Centers for Medicare and Medicaid Services. Part B biosimilar biological product payment and required modifiers. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/Part-B-Biosimilar-Biological-Product-Payment.html. Accessed July 21, 2016. 2. Department of Health and Human Services. Medicare program; revisions to payment policies under the physician fee schedule and other revisions to Part B for CY 2016. https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-28005.pdf. Accessed July 21, 2016. 3. US FDA. Nonproprietary naming of biological products. Guidance for an industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM459987.pdf. Accessed July 21, 2016. 4. US FDA. Biosimilars: additional questions and answers regarding implementation of the biologics price competition and innovation act of 2009. Guidance for industry. http://www.fda.gov/downloads/Drugs/.../Guidances/UCM273001.pdf. Accessed July 21, 2016.