Biosimilars

Subscribe to Biosimilars

Prior to the 4th of July break, Senate and House Committees approved more than a dozen health policy bills, covering topics including:  surprise medical bills, health pricing transparency, drug prices and competition, various Medicare policies, and public health program reauthorization, among others.  The following are highlights of recent action.  Note that none of the bills has yet been considered by the full House or Senate, and all are subject to change during the legislative process.

Senate HELP Committee

The Senate Health, Education, Labor and Pensions (HELP) Committee approved S 1895, the Lower Health Care Costs Act of 2019.  This high-profile, bipartisan legislation would hold patients harmless from “surprise” medical bills for out-of-network services provided at an in-network facility, with payment to out-of-network providers set at the median contracted rate for in-network providers in the geographic area (a controversial “benchmark rate” proposal).  The bill contains separate protections regarding costs for emergency room and air ambulance services.  Additionally, S 1895 seeks to improve health care transparency by, among other things, banning what are described as “anticompetitive” terms in contracts between insurers and providers; providing patients with additional information on out-of-pocket costs; and regulating certain pharmacy benefit manager (PBM) pricing practices.  The legislation also includes numerous provisions intended to promote generic drug and biosimilar biological product innovation; improve health information exchange and strengthen health entity cybersecurity practices; and authorize various public health programs.  The Committee approved the bill on June 26, 2019 on a vote of 20-3.  Committee Chairman Lamar Alexander expressed hope for full Senate consideration of the bill in July.

During the same markup, the HELP Committee also approved S 1173, the Emergency Medical Services for Children Program Reauthorization Act, and S 1199, the Poison Center Network Enhancement Act of 2019.

Senate Judiciary Committee

The Senate Judiciary Committee approved the following four bills that are intended to help reduce prescription drug prices:

  • S 1227, the Prescription Pricing for the People Act of 2019, which would require the Federal Trade Commission (FTC) to study the role of PBMs in the pharmaceutical supply chain and provide Congress with related policy recommendations.
  • S 440, the Preserving Access to Cost Effective Drugs Act, which would bar patent owners from asserting sovereign immunity, including the sovereign immunity accorded to an Indian tribe, in certain drug patent disputes.
  • S 1224, the “Stop STALLING Act,” to authorize the FTC to take action against entities that file “sham” citizen petitions to attempt to interfere with approval of a competing generic drug or biosimilar.
  • S 1416, Affordable Prescriptions for Patients Act of 2019, which would authorize the FTC to challenge certain brand manufacturer practices (e.g., “product hopping” and “patent thickets”) that could discourage generic drug and biological use.

House Ways and Means Committee

The House Ways and Means Committee recently passed the following health policy bills:
Continue Reading Congressional Committees Advance Multiple Bills Addressing Surprise Medical Billing, Prescription Drug Policy, and Other Health Policy Issues

Delays AUC Requirement until 2020, Cuts Off-Campus Hospital Department Payments

The Centers for Medicare & Medicaid Services (CMS) has published its final Medicare physician fee schedule (PFS) rule for CY 2018. In addition to updating rates for 2018, the rule includes important policy changes, including an additional delay in implementation of appropriate use criteria (AUC) for advanced diagnostic imaging services and another reimbursement cut for off-campus hospital outpatient departments (although not as deep as proposed).  Highlights of the final rule include the following:
Continue Reading CMS Finalizes Medicare Physician Fee Schedule Update for 2018

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products.

What is a biosimilar product?

Biosimilar products are biological products that are highly similar to an FDA-approved biological product, known as a reference product. Notwithstanding minor differences in clinically inactive components, there can be no clinically meaningful differences between the biological product and the reference product in terms of the safety and efficacy.  In 2010, the Biologics Price Competition and Innovation Act (“BPCIA”) was enacted as part of the Affordable Care Act in order to provide an abbreviated licensure pathway for a biosimilar that partly relies on the data originally submitted to the FDA by the reference product sponsor for approval.
Continue Reading FDA Issues Draft Guidance on Labeling For Biosimilar Products

On November 13, 2015, the Centers for Medicare & Medicaid Services (CMS) is publishing its final rule updating the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for calendar year (CY) 2016. CMS estimates that total federal expenditures under the OPPS will drop by $133 million in CY 2016 compared to CY 2015 due to the changes in the final rule, while overall ASC payments are expected to increase by approximately $128 million in 2016. The OPPS update for 2016 is -0.3%, driven in large part by CMS’s correction of a $1 billion error it made when estimating “packaged payment” for clinical laboratory tests under a policy implemented in 2014. Specifically, the -0.3% update reflects a 2.4% market basket increase, which is partially offset by a -0.5% multifactor productivity (MFP) reduction and an additional 0.2% reduction (both mandated by the Affordable Care Act), further reduced by a 2.0 percentage points to recoup the prior $1 billion overestimation of laboratory test packaging. Hospitals that fail to meet the Hospital Outpatient Quality Reporting (OQR) Program reporting requirements are subject to an additional 2% reduction. The actual update for individual procedures can vary dramatically, however, based on reconfiguration of ambulatory payment classifications (APCs) and other policies in the rule. Other highlights of the final rule include the following:
Continue Reading CY 2016 Medicare OPPS Spending to Drop by 0.4% under Final OPPS Rule; ASC Payments Get Small Boost

Two Congressional committees are holding hearings this week on health policy issues.  First, the Senate Health, Education, Labor and Pensions (HELP) Committee has scheduled a September 16, 2015 hearing on “Achieving the Promise of Health Information Technology: Improving Care Through Patient Access to Their Records.”   The HELP Committee also will hold a September 17 hearing on “Biosimilar Implementation: A Progress Report from FDA.” Second, on September 18 the House Energy and Commerce Health Subcommittee will examine four Medicaid bills:
Continue Reading Congressional Hearings to Focus on Health IT, Biosimilars, Medicaid Program Legislation

On August 28, 2015 the federal Food and Drug Administration (“FDA”) issued two important policies regarding naming biological products, including biosimilars. First, FDA released a notice announcing the availability of draft guidance entitled “Nonproprietary Naming of Biological Products.” The draft guidance highlights FDA’s current thinking on the need for biological products licensed under the Public…

On July 15, 2015, the Centers for Medicare & Medicaid Services (CMS) published its proposed rule to update the Medicare physician fee schedule (MPFS) for CY 2016 – the first rulemaking since the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repealed the sustainable growth rate (SGR) formula.  Under the proposed rule, the 2016 MPFS conversion factor (CF) would be $36.1096, compared with the 2015 CF of $35.9335, reflecting a 0.5% update factor specified under MACRA and a budget neutrality adjustment of 0.9999.  Note that the CF is subject to change in the final rule, however, if CMS does not meet a statutory target for expenditure reductions related to its review of misvalued procedures (discussed below). The proposed rule addresses numerous aspects of Medicare Part B and other CMS program policies.  Highlights include the following: 
Continue Reading Proposed CY 2016 MPFS Rule Takes First Steps in Implementing MACRA Reforms

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are intended to clarify both scientific and regulatory considerations for a broad range of stakeholders, including drug companies, in manufacturing biosimilars.…

A new draft guidance document on formal meetings between the FDA and biosimilar biological sponsors is now available from FDA. The draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products. Further, the draft guidance assists sponsors and applicants in…

This post was written by Erin Janssen.

The Food and Drug Administration (FDA) has announced the rates for biosimilar and prescription drug user fees for FY 2013. By way of background, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes FDA to assess and collect user fees for certain activities in connection…

This post was written by Erin Janssen. The FDA has issued a series of draft guidance documents addressing an abbreviated pathway for biosimilar product development under Section 351(k) of the Public Health Service (PHS) Act, as amended by the Biologics Price Competition and Innovation Act of 2009. These guidances are intended to assist applicants in navigating an abbreviated approval pathway for biologic products that are “highly similar” or “interchangeable: and have no clinically-meaningful differences of purity, potency and safety to an already FDA-licensed biologic product in the U.S. Providing much-needed and long-awaited information, the three draft biosimilar guidances address common questions, and scientific and quality considerations related to an abbreviated development pathway of biosimilars, as follows:
Continue Reading FDA Issues Three Draft Guidance Documents on Biosimilar Product Development; Announces May 11 Public Hearing

This post was also written by Erin Janssen.

The FDA has released draft guidance for industry entitled “Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations.” This draft guidance is intended to assist sponsors of certain late stage premarket and postmarket investigations in developing selective/targeted safety data…

The House Energy and Commerce Health Subcommittee has held hearings on reauthorization of the Prescription Drug User Fee Act and generic and biosimilar user fees, and an additional hearing on reauthorization of Medical Device User Fee Act is scheduled for February 15, 2012.  The House Ways and Means Health Subcommittee held a hearing on how…

The House Energy and Commerce Health Subcommittee has announced a series of hearings on FDA user fees for prescription drugs, generic drugs, biosimilar drugs, and medical devices. The hearing schedule is as follows: a February 1, 2012 hearing will address reauthorization of the Prescription Drug User Fee Act; on February 7, a Subcommittee hearing will…

The House Energy and Commerce Health Subcommittee has announced a series of hearings on FDA user fees for prescription drugs, generic drugs, biosimilar drugs, and medical devices. The hearing schedule is as follows:

  • A February 1, 2012 hearing will address reauthorization of the Prescription Drug User Fee Act;
  • A February 7 hearing will focus on

…

On December 7, 2011, the Food & Drug Administration (FDA) published a notice discussing its proposed recommendations for implementing the ACA’s user fee program for biosimilar biological products for FYs 2013 through 2017. The notice summarizes the four proposed types of fees (Biosimilar Product Development Fees, Marketing Application Fees, Establishment Fees and Product Fees), along with …