Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains differences between follow-ons and biosimilars.
Transcript:
Does a designation of an innovator product as a drug as opposed to a biologic make it easier or harder to enter the market with a follow-on?
It really depends on the specific product you’re talking about. In some cases, it could be easier, in some cases it could be harder. I will say upfront that very soon, in 2020, all those products, like insulin, which are now regulated as drugs and get approved through NDAs and 505(b)(2) applications, they’re all going to be transitioned to biologics and they’re going to have to submit BLAs.
So, this issue won’t exist for much longer. But again, given the current state it really does depend on the particular drug involved. So for products like insulin that are currently regulated as drugs, there are two pathways to get approval of a “generic.” There’s the NDA pathway and the 505(b)(2) pathway. I think a lot of these products are probably so complex that the NDA pathway isn’t a very realistic possibility.
The FDA will take the position, and has taken the position, that you can’t really demonstrate that the active ingredients are the same. On the other hand, if it were regulated as a biologic and you could do a biosimilar, biosimilars don’t have to be identical. In that sense, it might be easier for some of these products to get approval as a biosimilar because you don’t have to show the level of identity that you do to get an ANDA. The other thing is that biosimilars can be supported by clinical data whereas NDAs cannot. I guess the third issue that folks need to look at is the level of exclusivity. Biologics have 14 years of exclusivity, so if you’re blocked by that, that’s going to be a lot longer than you’d be blocked if the product were subject to an NDA. The longest exclusivity period is 5 years, and even adding on the delays for potential patent litigations, the most it’s going to be is 30 months. In some cases if you’re looking at a reference product that has the 14 years of exclusivity, you’d probably prefer that it were regulated as a drug rather than a biologic.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.