By Nitisha Pyndiah, PhD

HW reports

HW was at FDA for the Part 15 public hearing on facilitating competition and innovation in the biological products marketplace

 On September 4, 2018, FDA held a public hearing to hear comments from different stakeholders on FDA’s Biosimilar Action Plan (BAP).

HW was there and reports. This meeting was a great opportunity to listen to patients and patient advocacy groups express their concerns and reminding us all, why we work in the field. Industry leaders and physicians also talked about the gaps that they identified, and innovator drug manufacturers presented arguments against biosimilars.  

A major discussion topic was about interchangeable products; patient advocacy group explained their concerns over patients having to switch to different biosimilars after being stable on a treatment thus highlighting the need to increase patients and healthcare providers education about biosimilars. Speakers expressed their views on the changes that they would like to see including those to the purple book. Of no surprise, originator product developers questioned the safety of switching from one biosimilar to another, but FDA responded promptly and clarified that the risk was similar or greater when switching within the same drug class or when the originator drug manufacturer makes manufacturing changes, which is common practice. There were also still discussions about the use of random suffixes for non-proprietary names and the fact that they could mislead when it comes to pharmacovigilance and also make biosimilars look inferior to the reference product. Overall, an interesting meeting where participants called for “real-life data” on biosimilars. Commissioner Gottlieb intervened to express FDA’s strong support to biosimilar developers in an aim to reduce the high cost of biologics. He emphasized on the fact that he was not satisfied of the current state of biologics market and that half of the biosimilars approved are not on the market. Commissioner Gottlieb did mention that FDA was working with the Federal Trade Commission (FTC) to work on the gamic tactics to delay competition. Certain participants asked if FDA could collaborate with the US Patent and Trademark Office to resolve intellectual property issues related to originators preventing biosimilars to enter the marketplace. One of the features of the BAP is FDA’s initiative to reduce gaming of FDA requirements by working with legislators to close loopholes.

In this blog post, I propose to list FDA’s BAP key actions and discuss items covered during the Part 15 hearing:

“Developing and implementing new FDA review tools such as standardized review templates”

“Creating information resources and development tools for sponsors of biosimilar applications”

“Enhancing the purple book to include more information about approved biological products”

Most speakers commented on their wish to see the purple book improved. The Biosimilar Forum and an originator company explained that a new column to designate biosimilars or interchangeable products should be added for clarification purpose. The Biosimilar Forum also noted that adding the date of exclusivity expiration would be very useful to sponsors. An industry representative added that manufacturing changes such as the number and types of changes should be added to the purple book. Other speakers also expressed their wish to have patent information listed in the purple book such as in the orange book.

“Actively exploring the potential for entering into new data sharing agreements with foreign regulators to facilitate the increased use of non-US licensed comparator products in certain studies to support a biosimilar application”

A company on the biosimilar side, spoke about using non-US comparators for interchangeables, and, a nonprofit organization, spoke about using non-US comparators if FDA multinational data shows that they are within acceptable FDA ranges. FDA was also urged to define analytical requirements for non-US reference product, no more no less.

“Establishing a new Office of Therapeutic Biologics and Biosimilars (OTBB) to improve coordination and support of activities under the BsUFA program”

FDA already established the Therapeutic Biologics and Biosimilars Staff (TBBS) under the Office of New Drugs (OND) to coordinate with other offices at CDER to ensure consistent review. FDA is now in the process of transferring TBBS to the new OTBB. This transition will allow to improve coordination, accelerate response time to the different stakeholder and support policy development.

“Building on the FDA’s Biosimilar Education and Outreach Campaign”

Patient advocacy groups explained that they wanted to understand better how a biological product is biosimilar. They wish to understand the analytical characterization better.

Some mentioned that they needed education when the patient goes to the physician practice as not all patients will educate themselves online.

This week, FDA published a useful resource to help explain the biosimilar development process and the data required to demonstrate biosimilarity. Link

“Publishing final or revised draft guidance on biosimilar product labeling to assist sponsors in determining what data and information should be included in the labeling”

“Providing additional clarity for product developers on demonstrating interchangeability, including by publishing final or revised draft guidance”

Several stakeholders mentioned their concerns about interchangeability, mainly, patient advocacy groups explained that they do not wish for the pharmacist to change the treatment for an interchangeable product without approval of the physician or the patient specially when the patient is finally stable on a treatment after series of complications.

Industry representatives recommended to include the scope of interchangeability designations in product labeling. An industry representative recommended clarifying the guidance on interchangeability, including information on changes in formulation. Several industry speakers pushed for the inclusion of non-US comparator for interchangeables.

“Providing additional clarity and flexibility for product developers on analytical approaches to evaluating product structure and function to support a demonstration of biosimilarity”

“Providing additional support for product developers regarding product quality and manufacturing process, including by identifying physical product quality attributes that are most critical to evaluate, and by exploring ways to reduce the number of lots of the reference product required for testing”


HW experts can help you with the development of your biosimilar, we are on the forefront of biosimilar policies and regulations we’ve been developing biosimilars for 16 years – and can assist you from early to late stages whether it is to advise regarding your analytical and functional studies, your non clinical studies, your clinical studies, your manufacturing process, your IND and BLA preparation or to submit your regulatory submissions to FDA. HW can also assist you with any FDA communications and prepare your materials for meetings.