Issue:March 2020

GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 1, a Global Review

Part One of a Four-Part Series

Part 1: A Review of 2019 Product Approvals
Part 2: Notable Drug Delivery and Formulation Product Approvals of 2019
Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2019
Part 4: The Drug Delivery and Formulation Pipeline

By: Kurt Sedo, VP of Operations, and Tugrul Kararli, PhD, President & Founder, PharmaCircle

The topline pharmaceutical product approval figures are in for 2019, and they largely reflect in terms of number and product types what was reported for 2018. It’s hard to judge whether or not this is a positive indicator for the sector. It’s always comforting to see continuation, but there is the suspicion that the environment is changing, and the industry may not be properly prepared to address the accompanying opportunities and challenges.

Any number of reviews and reports discuss the number and nature of US FDA product approvals. This four-part series starts with a review of the 2019 approval numbers focused on technologies and dosage forms, essentially the nuts and bolts underpinning these products and their therapeutic benefits.

To better identify trends related to drug delivery and formulation, the Global Drug Delivery & Formulation Report focuses on “innovative” product approvals. This is a mixed group of products that incorporate a new molecular entity (NME), provide a new dosage form of an NME or Previously Approved Active (PAA), or represent a new combination of NME or PAA actives. Multisource products, generics, and biosimilars are excluded.

This first article summarizes the 2019 product approvals in the three major world markets, the United States (FDA), Japan (PMDA), and the European Union (EMA). From a technology perspective, this represents a historical review. Given that innovative products take on average 8 to 10 years1 to get through clinical development and regulatory review, the technologies underpinning these products were developed at least a decade ago. What about multisource approvals, generics, and biosimilars? These products represent ancient history. Approved in 2019, these products are essentially copies of products approved a decade or more ago based on technology and formulation decisions made two decades ago.

This report tries to connect the past with the present to suggest what the future will deliver from a product and technology perspective. Click here to download/view part 1 of the entire report.