FDA Commissioner Scott Gottlieb released a Biosimilars Action Plan focused on four key strategies: improving efficiency of the biosimilars approval process, maximizing scientific clarity, developing effective communications and supporting market competition. The plan includes an emphasis on increasing education around the safety and benefits of biosimilars, a key priority for the Biosimilars Forum.
“The Biosimilars Action Plan marks an important step forward for cultivating a robust biosimilars market in the United States,” said Juliana M. Reed, President of the Biosimilars Forum. “Commissioner Gottlieb has been a champion of biosimilars, and his plan would help support the development and approval of these innovative drugs in a number of key ways. In particular, we are encouraged to see proposals that would increase efficiency of FDA review, expand education efforts and provide additional guidance for biosimilars developers. While there are additional details that still need to be discussed, the Biosimilars Forum looks forward to working with the FDA to implement key aspects of this plan and put these life-saving drugs into the hands of even more physicians and patients.”
About The Biosimilars Forum
The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.
For more information, visit BiosimilarsForum.org.
SOURCE: The Biosimilars Forum