Dr Chelsee Jensen Comments on Recent Biosimilar Approvals, Patient Access

Chelsee Jensen, PharmD, BCPS, of Mayo Clinic explained both what the recent biosimilar FDA approvals mean for the industry and ways to ensure all patients have access to biosimilars.

She discussed biosimilars at length at AMCP Nexus as a speaker during "Biosimilar Operational Readiness: Marketplace Trends and Regulatory Considerations" on October 17 and "Biosimilar Operational Readiness: Managed Care Stakeholder Response to Market Expansion Impact" on October 18. Jensen is a senior pharmacy specialist, working as a pharmaceutical formulary manager within the Division of Supply Chain Management at Mayo Clinic; she manages several specialty task forces.

Transcript

Recently, the FDA approved the first natalizumab and tocilizumab biosimilars. What was your reaction to these approvals and what hope does this provide for the industry's future?

I'm obviously very excited about these approvals; the more biosimilar competition, the better. However, what we need to recognize right now is that while these were FDA approved, they probably are not going to be entering the market.

For tocilizumab, we likely will not see this biosimilar coming to the market until potentially anywhere out to 2025. For natalizumab, I think it's out even further. That's just something to understand from a pharmacy level that while these are approved, they do take some time to get to the market.

For tocilizumab, specifically, it's only approved in the IV [intravenous] formulation where tocilizumab, the reference product, has a [subcutaneous] and an intravenous [IV] formulation, as well as the IV biosimilar only has indication of rheumatoid arthritis, so it has a skinny label. Just something to keep in mind as we get closer to the launch of this of: How are we going to implement it into a formulary as a health system with those skinny label indications.

For natalizumab, we don't have those skinny label hurdles to get over. This is, again, essentially equivalent to the reference product as far as indication, so there should be less operational hurdles in that space.

What challenges exist in ensuring that biosimilars are accessible to all, especially in vulnerable or marginalized communities? How can these challenges be addressed?

Well, I personally just think our vulnerable and marginalized communities are probably being treated at our rural referral or sole community hospitals out in the community, and we have to realize that biosimilars are a huge opportunity for those hospitals that are probably 340B eligible. Many reference products carry orphan drug exclusivities, therefore they're not mandated to offer a 340B price, whereas biosimilars do not have that orphan drug exclusivity and they can come out at a 340B price.

I'm hoping that biosimilars actually will increase access to these marginalized and vulnerable populations. However, education is always going to remain key. Educating the patient on, again, that biosimilars are equally safe and effective as reference products remains key. If there are financial considerations, still working with those patients to say, are there manufacturer co-pay assistance programs available out there to improve their access to care, as well.