Tag Archives: Biosimilars

FDA Issues Draft Guidance on Labeling For Biosimilar Products

The federal Food and Drug Administration (“FDA”) recently published a draft guidance on labeling for biosimilar products that is intended to assist applicants in developing draft labeling for proposed biosimilar products.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

CY 2016 Medicare OPPS Spending to Drop by 0.4% under Final OPPS Rule; ASC Payments Get Small Boost

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 … Continue Reading

Congressional Hearings to Focus on Health IT, Biosimilars, Medicaid Program Legislation

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: … Continue Reading

FDA Issues New Draft Guidance and Related Proposed Rule on Naming Biological Products

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 First, FDA released a notice announcing the availability of draft guidance entitled “Nonproprietary Naming of Biological Products.” The draft guidance highlights FDA’s current thinking on the need for biological products licensed under the Public … Continue Reading

Proposed CY 2016 MPFS Rule Takes First Steps in Implementing MACRA Reforms

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(MPFS) for CY 2016 – the first rulemaking since the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repealed the sustainable growth rate (SGR) formula.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 … Continue Reading

FDA Issues Three Biosimilar Final Guidances

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. … Continue Reading

FDA Releases “Purple Book,” Including Biosimilar Products

The FDA’s new “Purple Book” lists biological products licensed by FDA under the Public Health Service Act (the PHS Act). The publication includes information on whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act, and whether the FDA has determined a biological product to be biosimilar to … Continue Reading

FDA Draft Guidance on Biosimilar Product Development Now Available

This post was written by Jennifer Pike. 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 … Continue Reading

FDA Establishes FY 2013 User Fee Rates for Biosimilars and Prescription Drugs

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 with … Continue Reading

FDA Issues Three Draft Guidance Documents on Biosimilar Product Development; Announces May 11 Public Hearing

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 … Continue Reading

FDA Draft Guidance on Safety Data Collection for Late Stage Premarket & Postmarket Investigations

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 collection … Continue Reading

E&C Health Subcommittee Plans FDA User Fee Hearings in February

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 … Continue Reading

E&C Health Subcommittee Plans FDA User Fee Hearings in February

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 the … Continue Reading

FDA Publishes Notice on Biosimilar Biological Product User Fees

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 … Continue Reading

FDA Seeks Stakeholder Participation in ACA Biosimilars User Fee Meetings

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 … Continue Reading
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