FDA new actions advancing the agency’s biosimilars policy framework

  • Posted on: 14 December 2018
  • By: Shalini.Sharma


The bedrock of our mission is our consumer protection role – our obligation to protect patient safety. Part of our mission also inspires us to promote beneficial innovations that can advance patient care.

Timely and efficient regulatory processes ensure that the U.S. remains a driving force in global biomedical innovation. A robust pathway for generic entry after patents and other exclusivities have lapsed means that our market is one of the most competitive generic markets in the world. This helps balance the best of both opportunities for patients – timely access to the newest and potentially most beneficial medical breakthroughs; and immense value once the patents and exclusivities that incentivized the investments in those innovations have lapsed.

The competition from generics helps drive this innovation, by compelling life science companies and their investors to back new technology as a way to sustain the high margins that have helped fuel investment in these endeavors. It’s one reason why the life science industry realizes one of the highest rates of investment in research and development – almost 19 percent of revenues, on average.

But not all parts of the pharmaceutical market have been equally open to competition from more affordable products. This is especially true for biologic medicines, which are typically complex molecules produced by living cells, and are increasingly the backbone of modern therapy.

The new approval pathway for biosimilars, enacted in 2010, allows an applicant to rely on the FDA’s finding of safety and effectiveness for a biological reference product to support approval of a biosimilar and, therefore, develop the product at a potentially lower cost than the original reference product, provided the sponsor can demonstrate that the product meets the statutory standards for biosimilar approval.

The Biosimilar Action Plan  released last July advances our ongoing implementation of the Biologics Price Competition and Innovation Act (BPCIA). The plan improves the efficiency of the biosimilar and interchangeable product development and approval process. It increases scientific and regulatory clarity for the biosimilar development community. It provides for more communication and outreach plans for educating patients, clinicians and payors about biosimilars’ safety and effectiveness. And it takes a number of steps to help address branded companies’ gaming of FDA requirements.

The first two guidance documents provide greater clarity on scientific and regulatory considerations for the development of biosimilar and interchangeable products. We intend to update these new guidance documents regularly, to address development issues as they evolve.

This transition of biological products currently regulated as drugs to being regulated as biologics will enable, for the first time, products that are biosimilar to, or interchangeable with, these products to come to market. This is a watershed moment for insulin products, which millions of American take each day to maintain stable blood glucose.

There are currently no approved insulin products that can be substituted at the pharmacy level. One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway.

The final guidance provides recommendations to sponsors of proposed biological products that are intended for submission in a New Drug Application (NDA) that may not receive final approval under the drug pathway of the FD&C Act by March 2020 to carefully consider how they can align their development plans to account for the transition provisions of the new biologics pathway. Biological products that have been approved under section 505 of the FD&C Act will be removed from the FDA’s Orange Book on March 23, 2020, based on the agency’s position that these products are no longer “listed drugs.” That means that a follow-on applicant won’t be able to rely upon these NDAs for approval. They have to go down the biosimilars path after the transition. Products approved in NDAs that are deemed to be Biologics License Applications (BLAs) will be included in the Purple Book, which lists biologics licensed by the FDA under the PHSA.

The final guidance also describes the FDA’s plans for supplements to approved NDAs that are pending under the FD&C Act on March 23, 2020.  The FDA is working to ensure that there’s a seamless transition of approved NDAs for biological products that will be deemed licensed BLAs, and that there are minimal impacts on manufacturers and patients. Patients on medications that will transition from being regulated under an approved NDA to a deemed BLA won’t be affected by the transition.

FDA research shows that drug prices are directly related to the number of generic manufacturers in the market. The first generic competitor to market offers only a small discount to the branded product. But once three or more generic competitors enter the market, discounts can rise to 80 percent or more of the branded price.

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