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Joe D’Ambrosio Discusses the FDA’s Biosimilar Action Plan

Clarkston Consulting Partner Joe D’Ambrosio was interviewed on the impact of the FDA’s new Biosimilar Action Plan, specifically to North Carolina’s biotech and manufacturing industries. An excerpt of the article is below.

The United States has continued to lag behind other parts of the world – namely Europe – when it comes to the manufacturing of biosimilars. But will the U.S. Food and Drug Administration’s new Biosimilars Action Plan – aimed at upping access and driving down costs – be enough to spur manufacturing of such drugs out of the U.S. and the Triangle? Local experts say it’s a positive step, but that more guidelines and strategies will be needed.

In a statement earlier this week, FDA Commissioner Scott Gottlieb said Americans could have saved more than $4.5 billion in drug costs in 2017 if biosimilars had been more prevalent.

He added, “So, enabling a path to competition for biologics from biosimilars is a key to reducing costs and to facilitating more innovation.”

According to FDA, biosimilars are different from generic drugs because with generics, the active ingredients are the same as the brand-name drug.

However, biosimilars are “highly similar” to the brand-name product, according to the FDA, and can contribute to treating complex diseases with high unmet medical needs such as autoimmune disorders and cancer.

Read the full article here

“Biosimilar manufacturers must also demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of safety and effectiveness,” the FDA says.

FDA’s biosimilars plan calls for:

  • improving the efficiency of the biosimilar and interchangeable product development;
  • maximizing scientific and regulatory clarity for the biosimilar development;
  • developing effective communications to improve understanding of biosimilars; and
  • supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.

“It is clear that the FDA is serious about establishing a good, transparent regulatory environment for the development of biosimilars, which is fairly new, and that they are aware that biosimilars are here to stay,” says Dr. Jurij Petrin, senior vice president, global regulatory affairs at PRA Health Sciences, a Raleigh-based contract research organization.

The Biosimilars Action Plan is “written as a policy,” with “a lot of forward looking statements,” Petrin says. The FDA is planning to add more “order into the development of biosimilars, which are important drugs on a global basis.”

“Now that they’re coming into the U.S. [with 11 approved over the last several years], there’s more to come. Even though the FDA has already provided and prepared a number of different guidelines to develop biosimilars, more clarity and more guidances are needed for both sponsors as well as CROs to help them navigate the maze of development,” says Petrin.

Joe D’Ambrosio, a partner at Clarkston Consulting that works with global life sciences clients, says the companies that will likely have the most impact with this policy are CROs and contract development and manufacturing organizations, in the supply chain.

D’Ambrosio says that, largely, “any company that’s capable of of bringing these drugs to market,” is “investing in it already.” As companies follow the 11 products approved in the U.S., more investment in the space will follow suit, he adds.

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