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BIOSIMILAR APPROVALS

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Here are the top 5 biosimilar articles for the week of November 18, 2024. 

The Top 5 Biosimilar Articles for the Week of November 18

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

Articles

Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.

Boosting Health Care Sustainability: The Role of Biosimilars in Latin America

Although financial incentives introduced by Japan's 2022 health policy did not result in a reduction in overall drug costs, biosimilar use in oncology significantly increased.

Financial Incentives Boost Oncology Biosimilar Adoption, but Costs Remain Unchanged 

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1rem

Clinical

Assessing the Treatment Landscape for Multiple Sclerosis to Better Individualize Care

1.5 Credits / Cardiology, Neurology, Rare Diseases

Exploring Transthyretin-Mediated Amyloidosis and Its Phenotypes: A Comprehensive Approach to Patient Treatment

The Role of the Specialty Pharmacist in Optimizing Treatment for Amyotrophic Lateral Sclerosis: The Impact of Early Intervention, Patient-Centered Care, and Disease-Modifying Therapies in Slowing Disease Progression

Advancing Targeted Therapies Aimed at Smoldering Disease in Multiple Sclerosis

The Economics of Transthyretin-Mediated Amyloidosis: Balancing Equity and Access in Resource Allocation

Products in line to face biosimilar competition are projected to increase their list prices in advance, according to Vizient’s Pharmacy Market Outlook Report for Summer 2024.

Vizient Report Projects Price Inflation for Originators With Biosimilars in the Pipeline

Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.

Budget Impact Analysis of Biosimilar Natalizumab in the US

After a patient with multiple sclerosis (MS) was forced to pay exorbitant out-of-pocket costs for a brand name medication when she could’ve gotten a generic for way less, the patient filed a class action complaint against her employer, Johnson & Johnson (J&J), for violating the Employee Retirement Income Security Act of 1974 (ERISA).

Patient With MS Sues J&J Over ERISA Violation

The IQVIA Institute for Human Data Science’s most recent Global Use of Medicines report projected that market introductions of new biosimilar and generic drugs will increase projected losses for originator products from $111 billion to $192 billion over the next 5 years.

IQVIA Projects $192 Billion Loss for Originators by 2028 Thanks to Biosimilar, Generic Competition

Chelsee 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.

Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape

Dr Prerakkumar Parikh talks about recent FDA approvals for ms biosimilars and the first tocilizumab biosimilar

Dr Prerakkumar Parikh Reacts to FDA Approvals for First Neurology, Tocilizumab Biosimilars

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, gives insight into the growing world of biosimilars and the role formulary placement plays in biosimilar adoption.

In the second half of 2023, the FDA approved the first 

, which is also the first neurology and first biosimilar indicated for multiple sclerosis, as well as the first 

. Additionally, the FDA approved the first 

From a PBM's perspective, what was your reaction to the FDA approvals of the first MS biosimilar and the first tocilizumab biosimilar?

Yeah, [these are] exciting times as more biosimilars are flowing to the market, especially for newer categories like multiple sclerosis. I'm pretty sure we will see some market shifts happening in that category. Interesting, both [the natalizumab and tocilizumab products] are under the medical benefit right now. So, I think it will probably follow the same success stories of the oncology biosimilars.

Can you explain the role of formulary placement and tiering by PBMs and how these decisions affect the cost-sharing burden for patients who choose biosimilars over reference biologics?

Absolutely. The tiering for some of the biosimilars that have came out are on the specialty tier. So far on the on the pharmacy benefit side, we are seeing the adalimumab biosimilar on that specialty tier along with the brand name product, Humira. So, what that will do is it will allow for access. At the same time, if you have a low-WAC [wholesale acquisition cost] biosimilar at the same level as Humira and if a patient is paying a percentage co-insurance on that specialty tier, a low-WAC biosimilar is going to reduce that cost for the patient as well.

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.

Conference

Brian Biehn from Cencora makes predictions for the US biosimilar market based on recent FDA approvals

Cencora's Brian Biehn Forecasts Big Changes for the US Biosimilar Space

Brian Biehn, senior director of biosimilar commercialization at Cencora, formerly known as AmerisourceBergen, recaps some of the major regulatory updates for biosimilars in the United States and makes predictions for how the market will develop in the years to come.

2023 was a big year for biosimilars in the US, with the market introductions of 8 adalimumab biosimilars as well as regulatory approvals for the first biosimilar tocilizumab, nataliuzmab, and subcutaneous infliximab. How do you think these advancements will shape the biosimilar market in the coming years?

Yeah, 2023 was definitely a big year for biosimilars. As you mentioned, we continue to have really good momentum with approvals. The approvals are written into new molecules such as tocilizumab and natalizumab. The approval for natalizumab [marks] the first neurological biosimilar, which is expected to hit the market in 2024. All eyes are still on adalimumab, though, and the Humira biosimilars.

So, today we have 9 manufacturers that have [approvals and 8 launches for] biosimilars to Humira [reference adalimumab]. There are still a few in the pipeline. We do believe the success of the future market is going to be shaped by the Humira market, specifically for the pharmacy benefit space [overall] and those biosimilars to come. So they're all kind of looking at Humira and seeing how are those manufacturers going to do? How successful are they going to be? What is the adoption going to look like?

To date, we've seen slow uptake of those Humira biosimilars, but we are expecting that to become more widespread going into 2024 and 2025. We believe there's kind of a period here where [pharmacy benefit managers] and payers need to become comfortable with the Humira products; they need to put them on the formulary. Also, from a downstream perspective, customers and patients need to become more comfortable with these products. So, even though it's been a slow start for Humira [biosimilars] and that's probably the biggest thing that happened in 2023 with those [launches], we do see some upside and are expecting more adoption to occur in the coming years.

Now that ophthalmology biosimilars have been on the market for a year and both FDA-approved products now have interchangeability, what is the current status of ophthalmology biosimilars and how to do you see this changing going forward?

Ophthalmology biosimilars are doing well. We've seen month over month the adoption continues to increase. We do anticipate that this trend is going to continue as there are still more manufacturers in the pipeline, specifically for the Lucentis [ranibizumab] biosimilars, which already have the 2 biosimilars on the market.

We're also really interested to see where the Eylea [aflibercept] market goes. We're expecting, potentially in 2024, biosimilars will start to move in that market. We have some ongoing patent litigation occurring right now that could push that launch back to later, but the most optimistic right now is potentially 2024.

One of the things that we continue to talk about with ophthalmology biosimilars—we've talked about in the past and it's important to most of the biosimilar market categories, but more specifically this one—is education. We've heard that there has been confusion amongst providers and patients with these products, not being aware that they're available, being a little bit hesitant to use them because it is an injection into the eye. So, education still remains to be the largest barrier. We have seen that education gap tighten. As I've said, the adoption has increased over time, but I still think it's important for us as an industry to keep pushing that education forward and trying to combat any misinformation that's going on and drive awareness of these products.

Brian Biehn, senior director of biosimilar commercialization at Cencora, makes predictions for how big regulatory approvals in 2023 will shape the biosimilar space going forward.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the importance behind the FDA approval of Tyruko (natalizumab-sztn), the first neurology biosimilar and the first multiple sclerosis (MS) biosimilar to receive regulatory approval in the United States.

Tyruko was developed by Polpharma Biologics and will be marketed globally by Sandoz. The approval marks the fourth FDA approval for a biosimilar in 2023, following 

 (adalimumab-aaty), the autoinjector version of 

 (pegfilgrastim-cbqv), and the high-concentration version of 

What was your reaction to the FDA approval of the first neurology biosimilar, Tyruko, and why is this approval so important?

This is a really exciting approval. We have not had an approval in the neurology space [before]. This is a natalizumab biosimilar for relapsing forms of multiple sclerosis. It is extremely exciting because MS is such a debilitating disease. It's a very, very difficult disease to treat. These patients have many unmet needs, still, even with the number of treatments on the market today. There's still no perfect treatment for these patients.

So again, adding choices so that those patients can have more opportunity to potentially have a better experience with the biosimilar [or] maybe they see direct cost savings from the biosimilar. But I do think that choice [and] competition open the market to more treatment options for physicians and more options for patients as well.

This biosimilar is extremely big news. I know there's so much focus on the adalimumab biosimilars right now but introducing a brand new therapeutic area, with neurology and a biosimilar, is very, very exciting. And I'm really excited that the manufacturer [will be] able to bring this product to market and get FDA approval for this product. I'm really looking forward to it coming to market and providing more options for patients.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, shares her reaction to the FDA approval of Tyruko (natalizumab-sztn), the first biosimilar approved to treat multiple sclerosis (MS).

Neurology

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