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FDA’s Biosimilar Action Plan

In a recent press release, Food and Drug Commissioner Dr. Scott Gottlieb explained the agency’s plan for improving access and competition for biosimilars. Dr. Gottlieb’s emphasis on diversifying biosimilars comes as the FDA continues to strengthen the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

As part of the Patient Protection and Affordable Care Act (colloquially referred to as the ACA), the approval path for biologics is shortened for biologics that are biosimilar, meaning that the product is highly similar or interchangeable to an FDA approved biological product.

In order to create an abbreviated pathway to approval, the FDA created a working plan to alter regulations in a way to achieve consistent, efficient, and scientifically sound products. With those objectives, the FDA amended current procedures regarding evaluation, review, and approval to introduce a new category of products.

The BPCI Act is conceptually similar to the Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Act, which introduced an expedited approval process for drugs under the Federal, Food, Drug, and Cosmetic Act (FFD&C Act) to leverage available knowledge about a drug in order to lessen the expense and amount of resources needed for analogous drugs.

The Biologics Landscape in 2018

Less than 2% of Americans use biologics, but biologics represent 40% of prescription drug costs. By encouraging competition, this long-term reduces costs and encourages continued innovation. As a result, more money will become available to more and more smaller companies focusing on biosimilar discovery and innovation.

Seeking drug approval is a lengthy and expensive process with an unpredictable and uncertain outcome. Inflated research and development costs, coupled with the often-small pool of competition, is passed onto the patient, insurers, government subsidized options like Medicare and Medicaid, and ultimately, taxpayers. Biologics represent a new era of medical innovation as healthcare providers pivot to a more patient-centric course of treatment.

Breaking Down the Action Plan

The Biosimilars Action Plan is a long, encompassing document touching on various topics such as payment structures and the actual details of the new pathway to approval. Here are some main takeaways:

  1. Improving the efficiency of the biosimilar and interchangeable product development and approval process
    1. Improve the efficiency of product review through application review templates specifically for the 351(k) Biologics License Applications
  2. Maximizing scientific and regulatory clarity for the biosimilar product development community
    1. The FDA plans to increase communication to stakeholders and sponsors and provide additional guidance for completing the pathway
  3. Developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors
    1. There is a steep learning curve for everyone involved with the use of Biologics. The FDA wants to make available educational materials explaining the science behind the products
  4. Supporting market competition by reducing gaming of the FDA requirements or other attempts to unfairly delay competition
    1. The FDA’s goal is to create a conducive environment for new developments and will work with legislators to enact additional anti-competitive measures

The FDA notes that this process is dynamic and will evolve as more developers take advantage of the changing approval pathway. Many industry commentators see the BAP as a changing landscape for the market, as well as the way regulations will be added in the future.

Resources for Biosimilar Researchers and Producers

The development path for biosimilars can take years and can involve multiple clinical trials. InstantGMP™ PRO is a software system for managing clinical inventory and for producing clinical trial materials. This manufacturing execution system is ideal for pilot plants since it reinforces all the GMP requirements for production at an affordable price. InstantGMP™ INV is ideal for managing clinical trial materials since it can allocate materials and CTM to individual trials and is GMP compliant out of the box.

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