Alerts and Updates

FDA Estimates for Formal Meetings Regarding Development of Biosimilars Show Continued Growth of Biosimilars in the United States

October 2, 2018

FDA’s upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States.

Among the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the U.S. Food and Drug Administration to gain insight on moving a clinical development program for a proposed biosimilar product forward. Tracking meeting requests is also one way to measure the prospects for growth and health of the U.S. biosimilars industry. By that measure, the prospects for the U.S. biosimilars industry look bullish. This year, FDA revised its estimate for meeting requests upward by six respondents to Center for Drug Evaluation and Research (CDER) meeting requests, reflecting the industry’s confidence in the growth of biosimilar market share in the United States. 

FDA’s upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States. In 2014, Rand Corporation estimated biosimilar cost savings over the next decade to be $44 billion. By 2017, Rand Corporation estimated biosimilar cost savings over the next decade to be $54 billion. The increase in estimated cost savings is premised on biosimilars gaining in market share of biologics prescriptions. These signs are all pointing toward increased growth of the U.S. biosimilars industry.

The importance of taking advantage of meetings with FDA during the biosimilar development process cannot be emphasized enough. When requesting a meeting with FDA, the applicant should submit a meeting request to the application (i.e., investigational new drug application, biologics license application). If there is no application, then the request should be submitted either to the appropriate CDER division director or to the division director of the appropriate product office within Center for Biologics Evaluation and Research (CBER). 

When requesting a meeting, the sponsor should include:

  • The product name
  • The application number (if applicable)
  • Proposed proper name or proper name
  • Structure
  • Reference product’s name
  • Proposed indications
  • Meeting type being requested
  • A brief statement of the purpose of the meeting
  • A list of specific objectives/outcomes
  • A proposed agenda
  • A list of questions grouped by discipline
  • A list of all individuals with their titles and affiliations who will attend the meeting from the requestor’s organization
  • A list of FDA staff (if known) requested to participate in the meeting
  • The proposed date, time and format of the meeting 

This information will help FDA determine “the utility of the meeting, to identify FDA staff necessary to discuss proposed agenda items, and to schedule the meeting.”

FDA has proposed that the applicant submit a meeting package with the meeting request. The proposed package is intended to provide FDA staff with an opportunity to adequately prepare for the meeting. The meeting package should include:

  • Product name and application number (if applicable)
  • Proposed proper name or proper name (post licensure)
  • Structure
  • Reference product name
  • Proposed indication(s) or context of product development
  • Dosage form
  • Route of administration
  • Dosing regimen (frequency and duration) and presentation(s)
  • A list of all sponsor’s or applicant’s attendees and consultants with their titles and affiliations who will attend the meeting
  • Background that includes a brief history of the development program and the status of product development (e.g., chemistry, manufacturing and controls, nonclinical and clinical, including any development outside the United States, as applicable)
  • A brief statement summarizing the purpose of the meeting
  • The proposed agenda
  • A list of questions for discussion grouped by discipline and with a brief summary for each question to explain the need or context for the question
  • Data to support discussion organized by discipline and question

As FDA continues to seek ways to facilitate greater availability of biosimilar products in hopes of promoting price competition in the biologics market, there will be increased opportunities in the industry to enter the biosimilars market. While uptake of biosimilars in the U.S. may have been slower than anticipated to this point, it appears that the industry sees continued opportunities for growth in development of biosimilars.

For Further Information

If you have any questions about this Alert or would like more information, please contact Patrick C. Gallagher, Ph.D.; Neelaabh Shankar, Ph.D.; any of the attorneys in our Pharmaceuticals and Biopharmaceuticals Litigation and Regulatory industry group; or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.