The European Biomanufacturing Summit was held on May 31 and June 1, 2023, and was attended by industry leaders from multinational biotech and biologics companies, largely from Europe. The agenda on the first day of the conference included topics related to modernization and digitization of the pharmaceutical industry. The presenters talked about challenges in transforming […]
Introduction On November 17, 2022, Sen. Mike Lee (R-UT) introduced a Bill entitled the “Biosimilar Red Tape Elimination Act” with the intent to increase competition within the US biosimilar market and reduce consumer costs associated their development. The Bill proposes to eliminate the interchangeability requirement of conducting switching studies associated with biosimilar drug development. In […]
Yesterday, the FDA released additional educational material to aid patients and caregivers in understanding how biosimilars are approved and to explain the differences between and among original biologic products and biosimilars. With more and more biosimilar products hitting the market, these educational tools are designed to make the public more aware of options that they […]
Hello from sunny Orlando and the AAM annual meeting! The FDA’s Jacqueline Corrigan-Curay, Principal Deputy Director, CDER, FDA, had the honor of providing the FDA’s keynote address. She started her talk by highlighting some of the accomplishments of GDUFA II, such as calling out the 490 first-generic approvals and 553 complex-generic approvals out of a total […]
The biosimilars market is robust and, with continued progress, the savings to patients soar. According to FDA, there are currently 40 licensed biosimilar products and 3 interchangeable biosimilars, 24 of which are currently marketed. And since October of 2021, these products have captured between 3-89% of the market share, depending on the product. With several […]
The schedules for the 2023 Prescription Drug User Fees (PDUFA) (here), Biosimilar User Fees (BSUFA) (here), and Medical Device User Fees (MDUFA) (here) have been posted and are scheduled for final publication on October 7, 2022. However, the Generic Drug User fees (GDUFA) FR Notice has a stark word “WITHDRAWN” on the prepublication page with the […]
It’s no surprise that the use of generic drugs saves consumers and health plans big money. Now, add the savings being achieved from biosimilars (expected to increase significantly over the next year or two) and the amount is almost staggering! The just-released report, which can be found here, provides details that support the findings that […]
The most popular program of each year’s AAM Annual Meeting is always the CEO unplugged session. Oftentimes there are significant disagreements between the different CEOs regarding strategy, but this year there was almost complete agreement on strategic issues, policy, the marketplace, and regulatory issues. The four panelists were Sven Dethlefs, Ph.D, Executive Vice President, North […]
(Not that we had anything to do with Califf’s confirmation but we are all glad that this is in the Agency’s rearview mirror and it now has a permanent rudder for the foreseeable future.) Anyway, the AAM annual meeting is in full swing and I thought that I would give a few bullet points of […]
On January 31, 2022, CDER released its Guidance Agenda for new and revised guidances expected to publish in 2022. While the list is somewhat aspirational, it provides a window into what the Center is working on and what we might see this year. The document lists 98 new and revised guidance and can be found […]
