The FDA and the European Medicines Agency announced today that the mutual recognition agreement on good manufacturing practice (GMP) inspections between the European Union and the United States now includes 4 additional EU member states.
The FDA and the European Medicines Agency (EMA) announced today that the mutual recognition agreement between the European Union and the United States now includes 4 additional EU member states: Czech Republic, Greece, Hungary, and Romania.
The extension of the agreement signals the FDA’s confirmation that these 4 states can carry out good manufacturing practice (GMP) inspections equivalent to those conducted by the FDA. The EMA says that all EU member states will be recognized by the FDA by July 2019, with 2 more additional member states slated for FDA recognition by June 2018 and a further 6 member states scheduled for December 2018.
Initially, the EU and FDA will focus on inspections that are conducted within their own respective territories, but the nations represented in the agreement have the option to rely on inspection reports issued by any other recognized authority for manufacturing facilities located outside their respective territories. Each year, according to the EMA, about 40% of all finished medicines that are marketed in the European Union are imported from overseas. For approximately 85% of medicines sold in the European Union, at least 1 manufacturing step takes place in a foreign territory.
Mutual recognition, says the EMA, not only helps EU and US regulators to avoid duplicative efforts and better allocate their inspection-related resources, but also improves the agencies’ abilities to identify and address potential problems at sites before they become public health risks.
Today’s announcement follows a November 2017 announcement that the respective agencies of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom would be recognized as capable of conducting GMP inspections that meet the FDA’s specifications and an August 2017 announcement that the FDA would share full inspection reports with both the EMA and the European Commission (EC). While the FDA had previously maintained confidentiality agreements with the EMA and EC since 2003, these earlier arrangements did not include the US’ ability to share full reports, inclusive of commercially confidential information such as trade secrets.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.