Jeffrey Casberg Highlights Regulatory, Legal Barriers That Impact Drug Launch Dates

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discussed some of the regulatory and legal hurdles that generic and biosimilar companies have to face on the road to market launch.

Transcript

What regulatory and legal delays are expected to impact drug release dates?

Sure, so we're going to be speaking at AMCP [Academy of Managed Care Pharmacy Annual Meeting] in Chicago on both the traditional and specialty pipeline and what regulatory or legal or FDA issues impact drug launches. The first one that will hit is the drug patents and the drug patent thicket, there could be between 3 or 4 and 200 patents on a given molecule. And getting through all those patents inhibit multisource competition and at-risk launches. So, when generic or biosimilar companies are thinking about bringing these multisource products to market, there's sometimes unknown patent protection and if they launched during that unknown patent protection, it's an at-risk launch. So, we'll talk about that a little bit. Settlement agreements between brand companies and biosimilar and generic companies where they meet and decide, "OK, you guys can launch at this date." That avoids litigation and affects timing of launches. FDA advisory committee meetings, especially from a clinical perspective, impact approvals and launches; complete response letters, or CRLs, [there have been] a lot of those in the last few years. We'll mention that. And with the pandemic itself, inspection site delays have delayed launches of molecules over the last couple of years.