The top 5 biosimilar articles for the week of February 17, 2025.

 (insulin-aspart-szjj) as the first biosimilar to reference Novolog (insulin aspart) for the treatment of adult and pediatric patients with type 2 diabetes.

: The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to 

, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.

 with a mix of challenges and opportunities, with the potential to shape the future of drug access and affordability for patients across the nation.

 a pivotal year for biosimilars with Amgen's Wezlana leading ustekinumab biosimilar launches, potentially driving savings and access, as highlighted by Dracey Poore, MS, of Cardinal Health.

 saved $67 million in 2023 through its strong adoption of biosimilars to curb the high costs of biologic therapies to treat chronic disease.

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Here are the top 5 biosimilar articles for the week of February 17, 2025.

The Top 5 Biosimilar Articles for the Week of February 17

Enhancing Biosimilar Adoption in Value-Based Oncology Care

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, highlighted biosimilars' role in making cancer care more affordable and accessible, especially for underserved populations. He stressed the need to balance cost-effectiveness with efficacy and called for greater payer trust in oncologists' biosimilar selections. Brewer also advocated for expanding "gold carding" to reduce prior authorization hurdles, promoting smoother biosimilar adoption in value-based care models.

This transcript has been edited for clarity; captions were auto-generated.

In a value-based oncology care model, what role do biosimilars play in ensuring equitable access to cancer treatments, especially for underserved patient populations?

Well, to the extent that you have, , biosimilars available, that that may be more cost effective, yet equally efficacious, relative to a particular treatment regimen, I think that goes a long way. Going back to the original cost-containment idea, so the more affordable you can make cancer care, the more accessible it is to to to broader populations.

That said, it's not always the best idea to just pick the cheapest if the cheapest isn't the best. You have to balance that with the efficacy of the treatment.

Can value-based oncology care models incentivize more rapid biosimilar uptake, and if so, what mechanisms should be in place to ensure their successful implementation?

That's really where the payers come in. We, as a practice, do a very good job of monitoring what's available on the market, what is the most efficacious, and then balance that with what is the most cost-effective. Unfortunately, at times we'll find that what we think the correct answer is, is not what the payer prefers, and the payer prefers brand B, C, or D.

And then it becomes a little difficult from a practice management perspective to keep on hand every "flavor" of biosimilar that's out there. I've told payers before we are not Baskin-Robbins. We don't carry all the flavors. That can lend itself to some conflicts with the payer.

So, I think the payers opening themselves up to trusting the community oncology providers a little more relative to the selection of biosimilars would go a long way in this space.

How do current reimbursement policies and payer models impact the integration of biosimilars into value-based oncology care, and what changes are necessary to promote their wider adoption?

I think opening up some of the prior authorization guidelines, more gold carding for trusted physician groups. I push for a gold card every chance I get, and I have absolutely no issue with with a payer coming back on the back end and saying, "Okay, well, let me take a look at 10- year files and see if it's not the fox guarding the hen house here."

We really are doing the right things for the right reasons. So, I think there's an opportunity to partner more with the payers on that front and get the payers to back off. And the best way to get them to back off is to show that we are consistently providing the highest-value care in the most cost-effective manner.

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, discusses the role of biosimilars in making cancer care more affordable and accessible, as well as the need for greater payer trust in oncologists’ treatment decisions.

Here are the top 5 biosimilar articles for the week of February 10, 2025.

, a biosimilar developed by Sandoz, demonstrated biosimilarity to reference aflibercept (Eylea) in patients with neovascular age-related macular degeneration (nAMD).

 and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.

Committee for Medicinal Products for Human Use

 (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.

: Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant 

 for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.

: Of the 118 biologics losing exclusivity over the next decade, only 

, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.

The Top 5 Biosimilar Articles for the Week of February 10

The top 5 biosimilar articles for the week of February 3, 2025

 demonstrated clinical biosimilarity to reference ustekinumab after switching and maintained long-term comparable efficacy and safety up to week 52.

, a tocilizumab biosimilar developed by Celltrion, for the treatment of several rheumatic conditions. It is the third biosimilar to reference Actemra (tocilizumab) to be approved for US patients.

 demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.

 referencing Stelara (ustekinumab) in the US, ushering in a new class of lower-cost medicines for patients with rheumatic and gastrointestinal conditions.

 redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.

Here are the top 5 biosimilar articles for the week of February 3, 2025.

The Top 5 Biosimilar Articles for the Week of February 3

Josh Canavan, PharmD.

In an interview with Josh Canavan, PharmD, head of pharmacy at RazorMetrics, he discussed the role of pharmacy benefit managers (PBMs) in the biosimilar landscape. He emphasized the importance of PBMs in the development and approval process of biosimilars, and how they are responsible for ensuring that these medications are safe and effective.


Canavan also highlighted the importance of PBMs in educating patients and providers about biosimilars.

This transcript may be lightly edited for clarity. 

Do you have a preferred recommendation when you are suggestion education models for physicians and pharmacists?

The FDA has done a great job of providing education, and people typically trust that 

] also give specific links to clinical trials comparing biosimilars with biologics. There's a lot of data out there, so if you link directly to that clinical trial, specifically for a pharmacist or for a physician, they can see it in its original form basically, not something that we've created or something we've tailored. They can see the data. They can see all the endpoints that are there.

Multiple pieces of information help like the FDA website, clinical trials, and then we have our own section where we break it down a little bit simpler for patients or someone who's just not familiar with it quite yet.

What do you wish more people understood about the role PBMs play in the biosimilar space?

I think one of the things that maybe gets overlooked with PBMs is the amount of research they do before they put a medication onto their formulary. They typically have their own clinical teams, pharmacists, physicians, who are looking at all of these medications. They do research, they read the clinical trials like we've talked about, they look at comparative studies between biosimilars and biologics.

There's a lot of thought and detail that goes into it before it makes it on to their formulary. Once a PBM has added something to the formulary, they're very confident about its efficacy, its availability, how it's going to be received in the market.

I think that might be overlooked, the overall amount of time and effort that PBMs put into creating formularies, updating them, and making sure everything is correct for their members.

Josh Canavan, PharmD, head of pharmacy at RazorMetrics, recommends key educational resources for biosimilars, and emphasizes the extensive research conducted before pharmacy benefit managers (PBMs) add medications, including biosimilars, to their formularies.

Understanding Biosimilars Through Education and PBM Formulary Perspective

Here are the top 5 biosimilar articles for the week of January 27, 2025. 

 in adolescent and young adult patients with inflammatory bowel disease (IBD) found no significant differences in lab markers or disease activity between those on Remicade and those switched to biosimilar CT-P13 (Inflectra).

, a biosimilar ranibizumab was a clinically effective and cost-saving alternative in a study assessing Japanese patients with different subtypes of neovascular age-related macular degeneration (nAMD).

 has been shown to be as safe and effective as its reference product for osteoporosis treatment, potentially enabling significant cost savings in Japan’s health care system while addressing persistent misconceptions about biosimilar quality.

: Sarfaraz K. Niazi, PhD, dives into the role that 

biosimilar associations and organizations

 play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.

 across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

The Top 5 Biosimilar Articles for the Week of January 27

Here are the top 5 biosimilar articles for the week of January 20, 2025. 

 (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.

: Achieving global regulatory harmonization for 

 is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.

 from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.

: Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to 

Samsung Bioepis’ most recent market report

, showcasing notable pricing trends and market share disparities across therapeutic areas.

 has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.

The Top 5 Biosimilar Articles for the Week of January 20

Here are the top 5 biosimilar articles for the week of January 13, 2025. 

: Korean drugmakers hold over 50% market share in the 6 best-selling 

, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.

 demonstrated equivalent efficacy, safety, and immunogenicity compared with the originator in a phase 3 trial involving postmenopausal women with osteoporosis, paving the way for improved accessibility and cost savings in osteoporosis treatment.

 to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry.

: Sarfaraz K. Niazi argues that the Indian Central Drugs Standard Control Organisation 

(CDSCO) Biosimilar Guidelines need revision

 to align with current scientific understanding and focus on better manufacturing practices.

 showed biosimilar CT-P42 (Celltrion) is therapeutically equivalent to reference aflibercept in improving visual acuity in patients with diabetic macular edema (DME), with comparable efficacy, safety, pharmacokinetics, and immunogenicity at 24 weeks, with more long-term data expected.

The Top 5 Biosimilar Articles for the Week of January 13

Sarah Hudson-DiSalle, PharmD, RPh, FACCC

In an interview, Sarah Hudson-DiSalle, PharmD, RPh, FACCC, pharmacy manager at The Ohio State University Comprehensive Cancer Center – The James and The Ohio State University Wexler Cancer Center, highlighted how automating biosimilar selection through electronic health records (EHRs) significantly improves patient access to affordable treatments. 

She noted that biosimilars reduce patient out-of-pocket costs and streamline processes for health care teams. During a pilot program, automation in favor of biosimilars reduced the average time to treatment approval from 12 days to 4 days, enhancing efficiency for pharmacists, providers, and authorization teams. However, she also emphasized the challenges of payer alignment, insurance accuracy, and timely updates, which can impact the effectiveness of automated systems.

How could automating biosimilar selection through the EHR improve patient access to more affordable treatments?

So, we know with biosimilars the first thing is decreased costs. And with that, we have seen patients have decreased out-of-pocket expenses. There's also assistance that helps these folks pay their coinsurances or their co-pays. But really having that percentage, and many of the plans have a percentage out-of-pocket [costs]. The use of a biosimilar with the decreased cost has just less expenses for our patients.

So as I said before, we saw a decrease in our initial pilot from 12 days to 4 days. When your staff kind of comes to you in the middle of the pilot and says, "When can we turn this on for the other agents?" It was an overwhelming response from our team that said, "This really is more efficient for us. We had less time that our specially practiced pharmacists were making changes for interchangeability, less time for our providers. And then, also, we were getting patients into the chair much quicker."

So the authorization team really found a lot of benefit in having that information that comes to them. And you can also see that if the insurance in the [EHR] is not entered in correctly. Let's say the patient's secondary [insurance] is entered in as the primary insurance so the wrong biosimilar is picked, I hear about it. So, I hear about the things that maybe don't go right but when your team says, "Hey, I want this to work properly," I think it speaks volumes.


And one of the barriers that does occur is depending on how many payers that the system might have, or the practice might have—The James has a large payer mix, and so initially we have 25 payers that we used in this model—if you don't have alignment, or your advanced order group is not aligned with the payer's biosimilar, it can then have some downstream implications that occur with that. Or if the patient's insurance isn't updated appropriately in that time, you could have the tool picking the wrong insurance's biosimilar. That's probably where we have seen the advanced order group fail. And then updates sometimes too. It just takes a little bit of time to make sure that those updates [are done]. Those are human steps that we have to incorporate. I wish we could say, if we know when the biosimilar has changed, that would be an immediate evaluation from our finance team. It just takes a little time.

Streamlining Biosimilar Access: How EHR Automation Transforms Patient Care

The top 5 biosimilar articles for the week of January 6, 2025. 

 articles of the year highlight a significant shift in the pharmaceutical industry, with projections indicating strong uptake in biosimilars at the expense of the originator products, despite challenges like uptake disparities and safety concerns.

 for aflibercept biosimilars reflects significant progress in offering cost-effective treatments for retinal conditions like neovascular age-related macular degeneration, although patent disputes pose challenges to their market entry and adoption.

 (Celltrion) is therapeutically equivalent to reference aflibercept in improving visual acuity in patients with diabetic macular edema (DME), with comparable efficacy, safety, pharmacokinetics, and immunogenicity at 24 weeks, with more long-term data expected.

 to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.

 Sarfaraz K. Niazi argues that the Indian Central Drugs Standard Control Organisation 

Here are the top 5 biosimilar articles for the week of January 6, 2025. 