Priority Deliverables	Details
Improve the efficiency of the biosimilar and interchangeable product development and approval process
Develop application review templates specifically for 351(k) applications	Intended to streamline reviews and enhance public information about FDA’s evaluation of biosimilar and interchangeable products; templates will be formatted specifically for data and information inherent to 351(k) applications and approval standards specific to biosimilar and interchangeable products.
Transition the Therapeutic Biologics and Biosimilars Staff (TBBS) to the Office of Therapeutic Biologics and Biosimilars	Intended to: improve coordination and support of all activities under BsUFA and address additional biosimilar or overlapping biological product issues; accelerate response time to stakeholders; improve efficiency in providing development-phase advice to companies; support efficient policy development and implementation through the creation of additional guidance documents. OTTB’s establishment is part of a series of other Center for Drug Evaluation and Research structural changes, including the Office of New Drugs' restructuring. (Also see "One Lesson Of The OND Reorg: It Is Hard To Classify Diseases" - Pink Sheet, 11 June, 2018.)
Implementation of Associate Director for Biosimilar positions in key scientific review discipline organizations	Provides targeted points of contact within review disciplines to improve efficiency and consistency of product development and approval.
Create information resources and development tools to assist sponsors in using state-of-the-art techniques	Intended to make development programs more efficient by reducing size and cost of clinical trials. Plans include: an index of critical quality attributes for use in comparing proposed biosimilars to certain reference products; pharmacodynamic (PD) biomarkers tailored to biosimilar development; and in silico modeling and simulation to evaluate pharmacokinetic and PD response versus clinical response relationships.
Maximize scientific and regulatory clarity for the biosimilar product development community
Rapid development of additional guidance to further clarify the regulatory pathway	Guidance topics include: reference product exclusivity; implementation of the “deemed to be a license” provisions; interchangeability considerations^1; statistical approaches to evaluating analytical similarity^1; and post-approval manufacturing changes¹. (Also see "Biosimilar User Fee Agreement Puts FDA On Hook For Delayed Guidances" - Pink Sheet, 22 September, 2016.) Agency will hold public meetings and hearings to seek additional input on possible alternative approaches.
Updated guidance on biosimilar approval for fewer than all indications for which the reference product is licensed	Excluded indications may include those protected by patents or exclusivities.
Proposed rule on interpretation of the definition of “biological product” in the Biologics Price Competition and Innovation Act (BPCIA)	Intended to provide additional clarity and predictability for sponsors regarding the appropriate review pathway.
Evaluation of regulations regarding submission and review of BLAs to ensure they account for current practices and authorities	Intended to improve regulatory clarity.
Development of an enhanced Purple Book	Will include more information about approved biological products and offer a modernized, interactive user experience.
Strengthening partnerships with regulatory authorities in Europe, Japan and Canada	Intended to facilitate greater efficiency in biosimilar development. Includes exploring data-sharing agreements that can give better insights into biosimilars’ real-world safety and efficacy and, in some cases, facilitate increased use of non-US-licensed reference products in studies to support a 351(k) application. (Also see "Biosimilars For US Market May Be Able To Rely On EU-Licensed Reference Products" - Pink Sheet, 17 July, 2018.)
Assess real-world evidence to support safety assessments and appropriate prescribing	Gather data from FDA’s Adverse Event Reporting System, Sentinel, and through partnerships with private insurers and the Centers for Medicare and Medicaid Services
Develop effective communications to improve understanding of biosimilars among patients, clinician and payers
Biosimilar Education and Outreach Campaign directed at healthcare professionals and other stakeholders	Released in October 2017; supplemented by a series of five videos on key concepts released in Spring 2018
FDA webinars	December 2017 webinar for healthcare professionals focused on the regulatory framework, development and approval; a future webinar will focus on labeling and prescribing
Educational materials directed at pharmacists and patients	April 2018 forum on Reddit AMA (Ask Me Anything) directed at pharmacists; a one-pager for patient audiences and video-format communications that can be used on social media for patients and other key audiences is targeted for Fall 2018
Support market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition
Efforts to promote competition	Clarify agency’s position on issues affecting exclusivity to better effectuate balance between innovation and competition. Coordinate with Federal Trade Commission to address anti-competitive behavior. Work with legislators to close any loopholes that may delay competition beyond exclusivity periods envisioned by Congress.
Restricted distribution abuses	Address cases in which brand companies refuse to sell samples of reference products under limited distribution programs to biosimilar developers
¹Commitment under BsUFA II

Avoiding ‘Groundhog Day’: US FDA’s Biosimilar Action Plan Applies Lessons From Generic Competition

More from Biosimilars

More from Biosimilars & Generics