Follow-on Biologicals

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The Food and Drug Administration (FDA) published a notice on May 10, 2011 seeking comments on its upcoming user fee program for biosimilar and interchangeable biological product (351(k)) applications. The user fee program was mandated by the Biologics Price Competition and Innovation Act of 2009, which was enacted as part of the Affordable Care …

On December 8, 2010, the Food and Drug Administration (FDA) published a notice requesting that stakeholders – particularly patient and consumer advocacy groups, health care professionals, and scientific and academic experts – notify FDA if they intend to participate in consultation meetings on the development of a user fee program for biosimilar and interchangeable biological product …

Today the FDA published a notice announcing public hearings on November 2 and 3, 2010 on implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was enacted as part of the Affordable Care Act (ACA). The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated…

The Obama Administration has released its proposed federal budget for fiscal year (FY) 2011. In its budget documents, the Administration reaffirms its commitment to enacting health reform legislation, and it assumes $150 billion in federal savings attributable to health reform over the 2011-2020 period. The document states that the budget “supports health insurance reform” by…

A number of Congressional panels have held hearings recently on health policy issues, including the following:

  • A Senate Commerce Subcommittee on Consumer Protection hearing on “Competition in the Health Care Marketplace.”
  • A House Judiciary Subcommittee on Courts and Competition Policy hearing on “Biologics and Biosimilars: Balancing Incentives for Innovation.”
  • A House Energy and Commerce Oversight

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On July 15, 2009, the Senate Committee on Health, Education, Labor, and Pensions (HELP) approved its health reform plan, the “Affordable Health Choices Act,” on a party-line 13-to-10 vote. In addition to significant insurance reforms, including a public health plan option, the legislation addresses a variety of other health policy issues, such as health care quality, health care workforce issues, preventive care, chronic care management, and a regulatory approval process for follow-on biologicals.
Continue Reading Senate HELP Committee Approves Health Reform Legislation

MedPAC has issued its June 2009 “Report to the Congress: Improving Incentives in the Medicare Program.”   Among other things, the report addresses follow-on biologicals, chronic care management, physician self-referrals involving imaging services, physician resource use measurement, graduate medical education, accountable care organizations, Medicare benefit design, and Medicare Advantage payment policy.

A lengthy new FTC report on “Follow-on Biologic Drug Competition" issued June 10, 2009 concludes that:

  • Competition between a biologic drug and a follow-on biological (FOB) is much more likely to resemble brand-to-brand competition than the dynamics of brand-generic competition under Hatch-Waxman.
  • Existing incentives that support brand-to-brand competition among biologic drugs – patent protection and

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A House Energy and Commerce Health Subcommittee hearing on June 11, 2009 will focus on a new Federal Trade Commission (FTC) report titled “Emerging Health Care Issues: Follow-on Biologic Drug Competition.”  The report will describe findings from an FTC investigation into the effects of a follow-on biologics pathway on competition and innovation. In particular,…

The Medicare Payment Advisory Commission (MedPAC) is meeting April 8-9, 2009 to discuss a variety of Medicare payment and policy issues, including the impact of physician self-referral on use of imaging services, potential Medicare savings associated with follow-on biologics, and Medicare Advantage payments, among others.

On March 12-13, 2009, MedPAC is meeting to discuss a number of health policy issues, including: accountable care organizations; physician resource use measurement; MIPPA Medicare Advantage payment report; improving Medicare’s chronic care demonstration programs; the effects of secondary coverage on Medicare spending; medical education; and follow-on biologics.