UPDATE : Monday, March 30, 2020
Korean biosimilar companies welcome US pro-biosimilar initiative
  • By Lee Han-soo
  • Published 2018.05.15 17:07
  • Updated 2018.05.16 10:08
  • comments 1

Korean biosimilar companies, such as Celltrion welcomed U.S. President Donald Trump’s “American Patients First” policy last Friday.

The initiative includes the U.S. government’s blueprint to lower drug prices and reduce out-of-pocket costs.

“One of my greatest priorities is to reduce the price of prescription drugs. In many other countries, these drugs cost far less than what we pay in the United States,” President Trump said. “That is why I have directed my administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”

The plan’s central goal focuses on increasing competition, easing negotiation, creating incentives to lower prices and lowering out-of-pocket spending on drugs.

To reach its central goal, the government will take steps to stop pharmaceutical companies from abusing regulations and abuse of patent processes, and encourage the use of biosimilars and generics (synthetic replication drugs) to promote price competition.

The U.S. Food and Drug Administration also released a statement stating they will bolster their attention toward biosimilars.

“The FDA shares the goal of ensuring that American patients have access to quality and affordable care that meets their needs,” FDA commissioner Scott Gottlieb said. “This is why we’re prioritizing actions to encourage the timely development and approval of generics and biosimilars.”

The FDA doesn’t have a direct role in drug pricing, however, by ensuring that regulatory requirements are efficient, predictable and science-based, the agency can help reduce the time, uncertainty and cost of generic and biosimilar product development, Gottlieb added.

Korean biosimilar companies such as Celltrion and Samsung Bioepis stand to reap benefit from the White House's new administrative plan.

Celltrion and Samsung Bioepis had previously both launched biosimilars – Inflectra and Renflexis -- of Remicade in the U.S.

In the first quarter of this year, Inflectra posted sales of $55 million in the U.S., increasing 3.2 times in sales from a year earlier, while Samsung Bioepis expanded their market share to 0.12 percent.

“Celltrion welcomes the White House’s ‘American Patients First’ plan and expects that the new initiative and FDA’s plan to prioritize actions to encourage the timely development and approval of generics and biosimilars will help form a pro-biosimilar atmosphere in the U.S.,” a Celltrion official said to Korea Biomedical Review over the phone. “We plan to continue our work in advancing biosimilar products and provide clinically valid and effective treatments to patients.”

Samsung Bioepis stopped short of commenting on the matter.


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