After the US Food and Drug Administration (FDA) released its 11-part biosimilar action plan, FDA has now announced that it will hold a public hearing to gather input “on how it can facilitate the development of biosimilars and ensure they enter the market in a timely matter,” reported RAPS.
The hearing is set to take place on September 4th, 2018 at FDA’s White Oak headquarters where they will solicit input from stakeholders on nine questions. The nine questions pertain to scientific and legal challenges to brining biosimilars to market and how to reduce competition barriers once they reach the market.
Since the creation of an abbreviated pathways for such products, FDA has approved 12 biosimilars but only a few of them have seen commercial launches. Legal challenges and hesitancy from insurers and healthcare providers have prevented the promise of lower cost competitions to the top selling biologics on the market.
According to RAPS, some of the question related to competition FDA hopes to gather input on includes how the agency can help biosimilars enter the market more quickly after approval and how the agency can promote confidence in biosimilars. The agency is also asking questions addressing any other challenges that have the potential to disturb the balance between innovation and competition regarding biologics and biosimilars.
Pearl Pathway understands the regulatory burdens imposed upon biologics. See our full list of service offerings to learn how our nimble team propels drugs and biologics to market faster through client-specific strategies.