FDA Draft Guidance on Biosimilar Product Development Now Available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A new draft guidance document on formal meetings between the FDA and biosimilar biological sponsors is now available from FDA. The draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological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 Further, the draft guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting package to FDA. The draft guidance provides good meeting management practices that are intended to provide consistent procedures that will promote well-managed meetings and ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately. The following five meeting types are described in the draft guidance: (1) Biosimilar Initial Advisory meeting (initial assessment of whether licensure is feasible for product, and if so, general advice on development of product); (2) biosimilar biological product development (BPD) Type 1 meeting (meeting that is necessary for an otherwise stalled BPD program to proceed); (3) BPD Type 2 meeting (meeting to discuss a specific issue or questions where FDA will provide targeted advice); (4) BPD Type 3 meeting (in-depth data review and advice regarding on-going BPD program); and (5) BPD Type 4 meeting (meeting to discuss format and content of application). Comments on the draft guidance should be submitted in writing, or electronically at www.regulations.gov, by May 31, 2013. 

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 biosimilar biological product and prescription drug development, for certain applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological product products are made, and on biosimilar biological products after approval. The FY 2013 rates for both biosimilar and prescription drug fees are as follows: initial and annual fees -- $195,880; reactivation fee -- $391,760; fee for a product application requiring clinical data -- $1,958,800; fee for a product application not requiring clinical data -- $979,400; fee for a product supplement requiring clinical data -- $979,400; product establishment fee -- $526,500; and product fee -- $98,380. These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013. 

Congress Clears FDA Safety & Innovation Act

On June 26, 2012, the Senate gave final approval to S. 3187, the Food and Drug Administration Safety and Innovation Act, following House action on June 20, 2012. The sweeping, bipartisan legislation would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and authorize user fee programs for generic drugs and biosimilar drugs. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction and predictability between industry and FDA during the review process. In addition, the bill would, among other things: take a variety of steps to alleviate drug shortages and protect the drug supply chain (although it does not include a national track-and-trace program); permanently authorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; offer incentives for the development of new qualified infectious disease products; promote expedited review of “breakthrough therapy” drugs; and make a variety of FDA administrative reforms. The President is expected to sign the bill. 

House, Senate Approve FDA User Fee/Drug Safety Bills

On May 30, 2012, the House of Representatives voted 387-5 to approve H.R. 5651, the Food and Drug Administration Reform Act. The House bill would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and authorize user fee programs for generic drugs and biosimilar drugs. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction, predictability, and certainty between industry and FDA. In addition, the bill would: take a variety of steps to protect the drug supply chain and alleviate drug shortages; permanently authorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; make a variety of FDA administrative reforms (including changes to the guidance process and conflict of interest rules); and revise the medical device and drug review processes. On May 24, the Senate approved its version of the legislation, S. 3187, the Food and Drug Administration Safety and Innovation Act, by a vote of 96-1. A conference committee will be appointed to resolve differences between the House and Senate versions of the bills. 

House Panel Unanimously Approves FDA User Fee Act

On May 10, 2012, the House Energy and Commerce Committee unanimously approved H.R. 5651, the Food and Drug Administration Reform Act. The legislation would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and it authorizes user fee programs for generic drugs and biosimilars. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction, predictability, and certainty between industry and FDA. In addition, the bill: permanently authorizes the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; makes a variety of FDA administrative reforms (including changes to the guidance process and conflict of interest rules); make various reforms to the medical device and drug review processes; and take steps intended to alleviate drug shortages. On April 25, the Senate Health, Education, Labor and Pensions (HELP) Committee also approved bipartisan legislation, the Food and Drug Administration Safety and Innovation Act, to authorize FDA user fees and address drug supply chain and drug shortage issues.

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 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:

•  Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: This draft guidance provides answers to common questions from potential applicants of such biosimilar products, including questions that may arise in the early stages of product development such as how to request meetings with the FDA, how to address differences in formulation from the reference product, and how to request exclusivity.

• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: This draft guidance is intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting to FDA an application, called a “351(k)” application after the relevant section of the PHS. This draft guidance describes a risk-based “totality-of-the-evidence” approach that the FDA intends to use to evaluate the data and information submitted in support of a determination of biosimilarity of the proposed product to the reference product. As outlined in the draft guidance, FDA has recommended a stepwise approach in the development of biosimilar products.

• Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product: This draft guidance provides an overview of analytical factors to consider when demonstrating biosimilarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a 351(k) application. This includes guidance on analytical studies relevant to assessing similarity and the importance of extensive analytical, physico-chemical and biological characterization in demonstrating that the proposed biosimilar product is highly similar to the reference product notwithstanding minor differences in clinically inactive components. This guidance may also provide useful information to applicants in the development of other proteins, such as those used in in vivo protein diagnostic products.


Comments are due by April 16, 2012. The FDA also has announced a May 11, 2012 public hearing to obtain input from a broad group of stakeholders on the draft guidances. The also FDA is interested in obtaining public comments regarding the Agency’s priorities for development of future policies regarding biosimilars.
 

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

This post was written by Erin Janssen and Celeste Letourneau.

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 for ongoing product characterization. Consistent with FDA’s evolving “quality over quantity” approach to safety assessment, this guidance provides recommendations on the type and amount of safety information that may be acceptable based on what is already known about a drug’s safety profile when certain aspects of a drug’s safety profile are sufficiently well established that comprehensive data collection is not needed. FDA’s view is that more selective or targeted safety data collection in appropriate circumstances may improve the quality of the safety assessment without compromising the integrity of the trial results. Selective/targeted collection may also serve lower costs and ease the burdens associated with conducting studies, which may ultimately result in improved use of clinical trial resources while providing long-term safety information. Comments on the guidance may be submitted until April 10, 2012.

 

February Congressional Health Policy Hearings

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 private sector payers are rewarding physicians who deliver high quality and efficient care.  Looking ahead, on February 14, the Senate Health, Education, Labor and Pensions Committee is holding a hearing on“Pain in America: Exploring Challenges to Relief.” 

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 focus on the new Generic Drug User Fee proposal and Biosimilar User Fee proposal; and on February 15, the Subcommittee will hold a hearing on reauthorization of the Medical Device User Fee Act.

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 new Generic Drug User Fee proposal and Biosimilar User Fee proposal; and
  • A February 15 hearing will examine reauthorization of the Medical Device User Fee Act.

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 the proposed performance goals and procedures for the user fee program. FDA will accept comments on the proposed recommendations until January 6, 2012. The proposal also will be the subject of a December 16, 2011 meeting. After the public meeting and review of comments, FDA will revise the recommendations as necessary and present them to Congress. 

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 applications. The meetings will comply with an ACA mandate regarding consultation with stakeholders on the goals for the biosimilar and interchangeable biological product application review process for fiscal years 2013 through 2017 in advance of submission of recommendations to Congress. FDA earlier had requested information on companies (and their trade associations) that would be affected by a biosimilar user fee program. Notifications of intention to participate are due by January 10, 2011.

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