The approval of Scott Gottlieb, MD, as FDA Commissioner would place a staunch advocate for biosimilar development at the head of the drug approval agency. Gottlieb’s past writings and actions signal his support for speeding up the pipeline for “robust pharmaceutical innovation.”
After a whirlwind of rumors on March 10, President Donald Trump confirmed that he would nominate Gottlieb to lead the FDA. Gottlieb, who had widely been considered the frontrunner for the position, is a less radical choice than other names that had been hypothesized for the post, but if confirmed he could have a transformative impact on the drug approval process, including the pathway for biosimilars.
Industry experts say Gottlieb favors a more rapid pace of drug approvals, but without discarding current safety and efficacy regulations. He has also advocated for greater transparency during the approval process, saying that the FDA should publicly release the complete response letters it sends when it rejects a drug application, instead of keeping them under wraps as they are now.
Perhaps the biggest clue into Gottlieb’s stance on biosimilar regulation comes from a Forbes column he penned with Gillian Woollett, MA, DPhil, in 2013, where they discussed how policy compromises can balance innovation and value, adding that “biopharmaceutical innovation is increasingly dependent on a functional regulatory path for quality biosimilars.”
Specifically, he praised the European Medicine Agency for its “abridged regulatory process that creates genuine savings,” while the FDA had yet to “make key regulatory decisions” regarding interchangeability, bioequivalence, and labelling indications. Biosimilars’ promise of innovation, he cautioned, “will be put at risk if policy makers start to implement blunt measures to restrict the pricing and access to these drugs by policies that reduce the market-based incentives that have attracted capital into these endeavors.”
Gottlieb’s support for biosimilars dates back even before the FDA implemented the Biologics Price Competition and Innovation Act in 2010. He penned an article for the American Enterprise Institute in 2008 that envisioned how an abbreviated regulatory pathway for biosimilars could produce cost savings and expand access to treatment. He recommended using the European Union’s biosimilar approval process as “a model for anticipating and resolving the scientific and policy issues related to biosimilars in the U.S.”
Gottlieb has worn many hats in the pharmaceutical and medical industries, but his most relevant experience was his role as deputy FDA commissioner of medical and scientific affairs under President George W. Bush. After serving as a practicing physician, he also currently works as a clinical assistant professor at New York University, is a resident fellow at the American Enterprise Institute, a Forbes contributor, and a health information technology adviser for HHS. He will have to give up these posts if the Senate confirms his nomination to lead the FDA, which appears likely.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
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.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
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.