September

Leading Article Info Here

Date Event Summary
Sept 2, 2015 Amgen v. Sandoz: Court of Appeals for the Federal Circuit denies Amgen’s motion seeking an emergency injunction
  • On 8/27/15, Amgen filed a motion for an emergency injunction to block Sandoz from launching Zarxio past 9/2/15 (the date on which the original injunction is set to expire) pending an en banc review.
  • The Court denied Amgen’s motion
Sept 3, 2015 Sandoz: Zarxio launched in the U.S.
  • Sandoz launched Zarxio, the first FDA-approved biosimilar in the U.S., at an initial wholesale acquisition cost that is 15% lower than that of the reference product, Amgen’s Neupogen.
Sept 8, 2015 MedPAC: Comments on CMS’ proposed rule, “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2016.”
  • In its letter, MedPAC commented on CMS’s 7/8/15 proposal to have all biosimilars referencing the same product be grouped into the same billing code and receive the same payment rate.
  • MedPAC expressed its support for the policy on the basis that it would reduce the price of both biosimilars and the branded products they reference. MedPAC also said that the biosimilar industry’s arguments against the policy are simply a means of seeking price protections; that the proposal could lay the groundwork for having the reference biologic and biosimilars in the same billing and payment code; and suggested that manufacturers should be willing to disclose their costs and revenues.
  • MedPAC: Comments on CMS’ proposed rule Medicare Program: Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2016
Sept 17, 2015 Senate HELP Primary Health and Retirement Security Subcommittee hearing: Biosimilar Implementation: A Progress Report from FDA
  • The Senate HELP Primary Health and Retirement Security Subcommittee held a hearing on FDA’s progress in implementing the Biologics Price Competition and Innovation Act (BPCIA). The only witness was Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research (CDER).
  • Key takeaways included the following:
    • FDA is working as expeditiously as possible to complete its guidances on labeling and interchangeability by year’s end. FDA is also working to complete its guidance on statistical approaches to analytical similarity within six months. However, given both the complexity of these issues and multiple clearances required, FDA can provide no guarantees.
    • FDA is consulting with WHO on the development of their naming approach. While the approaches are similar, there is no guarantee that the two approaches will be identical.
    • If CMS moves forward with its plan to put biosimilars that reference the same brand biologic into single billing codes, the two agencies would develop an approach to use some codes, or “coding modifiers,” to track which patients received which drugs.
    • The agency it needs additional resources for educational campaigns around biosimilars.
Sept 22, 2015 Hillary Clinton Presidential Campaign: Releases Plan for Lowering Prescription Drug Costs
  • Democratic presidential candidate Hillary Clinton unveiled a plan designed to lower the cost of prescription drugs. Insofar as biosimilars are concerned, she proposed reducing exclusivity for reference biologics from 12 to 7 years, and speeding FDA reviews of biosimilar applications that have only one or two competitors in the marketplace.
  • Hilary Clinton’s Plan for Lowering Prescription Drug Costs
Sept 23, 2015 Senators Pat Roberts (R-KS) and Tom Carper (D-DE): Agree to author letter to Acting CMS Administrator Andrew Slavitt re: CMS’ 7/8/15 proposal to place biosimilars that reference the same brand biologic under the same billing code
  • Senators Pat Roberts (R-KS) and Tom Carper (D-DE) agreed to author a letter to Acting CMS Administrator Andrew Slavitt.
  • Letter expresses concern with respect to CMS’ proposed biosimilar reimbursement policy and urges CMS to “withhold the proposed Medicare reimbursement policy for biosimilars until the Food and Drug Administration (FDA) have completed regulations for these drugs and the biosimilar drugs pipeline and market are safe and stable.”
  • They are currently in the process of collecting additional Member signatures
Sept 28, 2015 Senator Ron Wyden (D-OR): Letter to Acting CMS Administrator Andrew Slavitt re: CMS’ 7/8/15 proposal to place biosimilars that reference the same brand biologic under the same billing code  
  • Senate Finance Committee Ranking Member Ron Wyden (D-OR) sent a letter to Acting CMS Administrator Andrew Slavitt expressing his support for the agency’s proposal to place all biosimilars that reference the same brand biologic under the same billing code.
  • In the letter, Wyden made the following claims:
    • “The Medicare statute specifies that Medicare payment to physicians for biosimilars be equal to ASP for products assigned to the same billing and payment code, plus… six percent of the reference biologic’s ASP.”
    • CMS’ proposal is both legally and economically sound, and would create competition among therapeutically equivalent products, instead of letting biosimilar makers set prices.
    • Disagreed with the argument that single billing codes would make it difficult to pinpoint which drugs cause side effects.
  • Wyden Letter to Acting CMS Secretary Andrew Slavitt