Hayden E. Klein

Chelsee Jensen, PharmD, pharmaceutical formulary manager at the Mayo Clinic, shares actions that can help improve patient confidence in biosimilars and weighs in on whether interchangeable ranibizumab biosimilars will impact how people view interchangeability designations.

What can health organizations do to ensure that biosimilars are well-managed and that patients are confident in their utilization?

I believe that to ensure that your organization remains engaged is to have timely report outs of how are we utilizing biosimilars? How are we saving money? How are our patients doing? Have there been any safety or efficacy signals reported back? Again, in our experience, there really have not. But continuing to keep those people engaged—How was the prior authorization process working? Are our payer landscaping changes? Are their contracting changes?—keeping all those players engaged is going to really help promote...the continued use of biosimilars, and again, reduction of health care expenditures overall.

How can health systems be active members in the fight for better biosimilar legislation and policies?

I would say really continuing to advocate and lobby, especially for real-time benefit checks on medical benefit. I think that would significantly reduce burden at many, many levels. So, continuing to push for that is really important, as well as CMS to keep in check of are they being transparent and what are Medicare Part D plans doing vs Medicare Part B plans doing? I know there was an Office of Inspector General report released in March of 2022 that showed a lot of Part D plans actually were not incentivizing or even covering biosimilars compared to the reference product. 

So, I think as we especially change to this more PBM [pharmacy benefit manager] space, in 2023 and beyond, it's really important to keep in focus of how those Part D and B plans covering biosimilars. Are they incentivizing them? And if we are not seeing health care savings, again, to take a better look on how those are placed on formulary tiers.

Recently, Cimerli, a ranibizumab biosimilar, launched on the US market with an interchangeability designation. However, because it is not a product dispensed in pharmacies, the designation will not apply. How might the market introduction of this product with this designation impact how stakeholders view interchangeability and the safety of biosimilars overall?

I truly don't think there's going to be much of an impact on how people view safety of biosimilars or interchangeability. I think it's truly going to come down to what are the covered indications and how are they contracting? So, maybe a health system might have to carry both the Byooviz [another ranibizumab biosimilar] and Cimerli because they didn't get favorable contracting and driving towards one, where you have patients who are covered by 1 indication and then the other product for the other indication. 

So, I think it's going to create a little bit of a management issue, but again, it's going to come down to competitive contracting. However, I do believe that providers will naturally move away from reference Lucentis.

Articles

Chelsee Jensen, PharmD, pharmaceutical formulary manager at the Mayo Clinic, explains what health organizations and health systems can do to better manage and instill confidence in biosimilars.

Dr Chelsee Jensen Speaks on How Health Systems Can Build Confidence in Biosimilars

Hi, I’m Hayden Klein for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of December 19, 2022.

 Biogen’s biologics license application for a biosimilar candidate (BIIB800) referencing Actemra (tocilizumab) for review. If approved, the drug will be used to treat several conditions, including rheumatoid arthritis, idiopathic polyarthritis, idiopathic arthritis, and sclerosis-associated interstitial lung disease.

Number 4: A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the 

 RD12014 and the reference product (Victoza) in healthy male participants.

Number 3: Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and 

 in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.

Number 2: Johnson & Johnson’s Janssen unit 

 against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.

 of its adalimumab biosimilar Idacio (adalimumab-aacf), making it the eighth biosimilar referencing Humira (adalimumab) to be approved in the United States.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of December 19

Hi, I’m Hayden Klein for The Center for Biosimilars

, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of July 25, 2022.

Number 5: The first 2 years of a Providence St. Joseph Health program to increase biosimilar uptake and cut costs created 

 and “biosimilar adoption rates that greatly exceed the US national average.”

 it will launch a pharmacokinetic (PK) study of AVT03, a proposed biosimilar for 2 different formulations of denosumab, which is used to treat serious bone conditions.

Number 3: Prestige Biopharma and Intas Pharmaceuticals 

 to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals made a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.

Number 2: Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were 

 by the FDA and the European Medicines Agency.

Number 1: In recent weeks, Celltrion Healthcare 

 (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.

The Top 5 Biosimilar Articles for the Week of July 25

Here are the top 5 biosimilar articles for the week of July 18, 2022.

Number 5: Abstracts from the European Hematology Association Congress 2022 confirmed 

comparable safety and effectiveness profiles

 between 2 rituximab biosimilars and the reference product (Rituxan) in patients with large B-cell lymphoma.

Number 4: Two experts in biosimilar intellectual property (IP) law broke down the 

issues that digital health and precision medicine face

 with IP and the history of case law that has created the current landscape.

Number 3: The 2022 “Trends in Biosimilars Report Preview” said 

 from the use of biosimilars climbed to $3 billion in the second quarter of 2022, for a total of $18 billion over the past 6 years.

Number 2: A real-world study on Pfizer and Celltrion Healthcare’s infliximab biosimilar (infliximab-dyyb, Inflectra; CT-P13) demonstrated 

positive clinical and patient-reported outcomes

 in patients with inflammatory bowel disease in the United States and Canada.

Number 1: Posters from the American Society of Clinical Oncology’s annual meeting showed the 

 of a trastuzumab biosimilar and a denosumab biosimilar in different types of cancer.

The Top 5 Biosimilar Articles for the Week of July 18

Here are the top 5 biosimilar articles for the week of March 28, 2022.

Number 5: Since the start of 2022, China’s National Medicinal Products Administration (NMPA) has made 

 to biosimilar products for various rheumatic conditions, including 3 biosimilar approvals and 1 biosimilar receiving an expanded indication.

Number 4: A patient with ankylosing spondylitis (AS) and ulcerative colitis (UC) was diagnosed with polychondritis 

, suggesting that patients with similar circumstances should be carefully monitored.

Number 3: Three biosimilars used for blood clot prevention 

 in British Columbia, one of several Canadian provinces that has a biosimilar switching program.

Number 2: While biosimilar uptake has been slow in the United States, a report showed that a utilization management program designed to promote biosimilar use 

Number 1: A trastuzumab biosimilar (HD201; Tuznue) demonstrated 

equivalence in efficacy and safety profiles

 compared with the reference product (Herceptin) in a phase 3 study of patients with erb-B2 receptor tyrosine kinase 2-positive (ERBB2+) breast cancer.

Hayden E. Klein

Dr Chelsee Jensen Speaks on How Health Systems Can Build Confidence in Biosimilars

The Top 5 Biosimilar Articles for the Week of December 19

The Top 5 Biosimilar Articles for the Week of July 25

The Top 5 Biosimilar Articles for the Week of July 18

The Top 5 Biosimilar Articles for the Week of March 28