Strategies for Effective Biosimilar Education, Adoption

Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center discussed educational tools that could help physicians overcome biosimilar adoption hesitancy, in an interview with The Center for Biosimilars

Abraham cites instances of successful, collaborative educational approaches and emphasizes their importance for targeted learning. However, he cautions that concerns about biosimilars, rooted in fear, may persist as an obstacle.

This transcript was lightly edited for clarity. 

Physician knowledge and acceptance are crucial for biosimilar adoption. What targeted education strategies can we implement to overcome potential physician hesitancy towards biosimilars?

The reality is that today, 2024, most clinicians, and I think it goes beyond physicians, it also includes clinical pharmacists, nurses, have perhaps not accepted, but are dealing with the reality of biosimilars and the fact that they're here to stay and the payers will decide whether biosimilars and the extent to which biosimilars are adopted.

We need to look at models, not just education, but at models of good collaboration. For instance, what 

 has done, basically he sat down, I've heard him tell the story. He sat down with the medical staff and put together a model of clinical pharmacists, nurses, and physicians working together.

Yes, there will always be still some lingering reluctance or fear mongering. I think in part that is a generational issue. I would say that most clinicians now in cancer care, immunology, or immune related diseases, are very familiar with the reality of biosimilars.

It's not a matter of really advocating further, those who are going to dig in their heels are going to dig in their heels, but they're going to be overrode because prior authorization will not be granted if you are not within the formulary. The payers are for better or for worse, the key driver here.

Videos

Ivo Abraham, PhD, RN, University of Arizona Cancer Center, suggests implementing targeted educational strategies to overcome physician hesitancy towards biosimilar adoption.

The Top 5 Biosimilar Articles for the Week of August 19

 for the first half of 2024 amounted to €26.9 million ($29.4 million), showing a strong start to the year, according to the biosimilar developer’s earnings report.

An analysis of subcutaneous biosimilar and originator tumor necrosis factor (TNF) inhibitors for rheumatic diseases found 

no significant differences in survival or discontinuation

 rates due to inefficacy or adverse events, with biosimilars showing lower overall discontinuation rates and higher retention rates.

 In an interview, Ha Kung Wong, an intellectual property attorney, explained that the 

Biologics Price Competition and Innovation Act of 2009

 provides a structured but optional "patent dance" for biosimilars, which helps streamline patent disputes, potentially reducing litigation and encouraging early settlements.

, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

 Sarfaraz K. Niazi, PhD, argues that the S-150 bill, also known as the 

"Affordable Prescriptions for Patients Act of 2023,"

 aims to reduce drug prices by addressing anti-competitive practices, such as patent thickets and product hopping, which hinder the entry of cheaper biosimilars and generics into the market.

To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of August 19, 2024.

The Top 5 Biosimilar Articles for the Week of August 12

Artificial intelligence (AI) technologies

 can support global health systems in integrating biosimilars into care models, reducing health care costs, enhancing treatment decision-making strategies, and narrowing the gap between high-income and low- and middle-income countries.

 receive good news regarding their ustekinumab biosimilars; Lupin Limited completes a phase 3 trial for a ranibizumab candidate; Julie Reed, MS, executive director of the Biosimilars Forum weighs in on pharmacy benefit managers and biosimilar access.

, also known as the "Affordable Prescriptions for Patients Act of 2023," aims to reduce drug prices by addressing anti-competitive practices such as patent thickets and product hopping, which hinder the entry of cheaper biosimilars and generics into the market.

 means that all 10 Canadian provinces now have an initiative to boost biosimilar adoption and savings by transitioning patients on reference agents to biosimilar options.

Here are the top 5 biosimilar articles for the week of August 12, 2024.

Ivo Abraham, PhD, RN.

Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center examined the integration of clinical practice and health economics research to expedite biosimilar access, in an interview with The Center for Biosimilars®.

Abraham highlights the established safety and efficacy of reference drugs, arguing that rigorous cost-effectiveness studies for biosimilars may not be necessary.

This transcript has been lightly edited for clarity.

How can the integration of both clinical practices and health economics research fall into the biosimilar development process to expedite access for patients while maintaining rigorous scientific evaluation?


The critical part here is really the fundamentals now of biosimilars come in and that's the economics. People say "yes, but don't we need cost effectiveness studies on biosimilars?" Well, if we know that another drug, your reference drug, has a certain level of cost effectiveness, clinical and safety outcomes relative to cost, we don't need to replicate an analysis like that because we know that statistically, our biosimilar product has equivalent margins in safety and effectiveness.

What we need to focus on here is if we have a biosimilar, relative to a reference product, and there is a price differential, it's no rocket science, you're going to have savings efficiencies.

That's where most payers really stop, although some of them have begun to listen to alternatives but what do we do with those savings? We can provide access on a budget neutral basis to either more biosimilar or to totally new treatments that at this moment, some patients, perhaps many patients, would not be eligible to receive but where a payer could say, "okay, we achieve efficiencies here and let's now put that to some good use and make more of our members have the care that they should have, but that at this moment, our guidelines do not cover."

That brings us to really a global aspect of biosimilars and that is that biosimilars have the potential because of cost differentials to promote access and equity in health care to people who otherwise might not get it. Now, within the clinical environments, we need to remember, the decisions are not necessarily made at the point of care.

Ivo Abraham, PhD, RN, University of Arizona Cancer Center, focused on the cost savings generated by biosimilars and how crucial reinvesting those savings into broader patient access to care is. This approach has the potential to improve health care equity and expand treatment options for patients.

Bridging Clinical Practice, Health Economics for Improved Patient Access

The Top 5 Biosimilar Articles for the Week of August 5

 a lot of discussion regarding biosimilar policies, in both the US and abroad, as well as 3 highly anticipated FDA approvals.

 predicted in 2025, several originator biologics set to face biosimilar competition in the next few years are projected to increase their list prices, according to 

Vizient’s Pharmacy Market Outlook Report for Summer 2024

 Value-driven health care strategies in Singapore’s public institutions have significantly increased biosimilar adoption, leading to reduced treatment costs and substantial savings for the health care system, 

 now available has helped countless patients deal with diseases for which traditional treatments were unsatisfactory. Individuals who have autoimmune diseases, cancer, and diabetes have benefited, as have those with previously untreatable genetic diseases. The most complex biologics first entered the market in the 1980s and 1990s, and for this reason, many of their patents are expiring. The concept of biosimilars was a rational idea that loosely mimicked the idea of generic drugs. However, because biologics are large, 3-dimensional, complex molecules, it took some time for regulatory agencies around the world to develop appropriate regulations.

 on glycan profiling of monoclonal antibodies (Mabs) receives praise and recommendations from Sarfaraz K. Niazi, PhD.

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

The Top 5 Biosimilar Articles for the Week of July 29

 with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.

 showed similar pharmacokinetic and safety profiles compared with the reference product Trulicity in healthy Chinese participants, according to a phase 1 analysis.

 that references Soliris (eculizumab), for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).1

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

Here are the top 5 biosimilar articles for the week of July 29, 2024.

Ivo Abraham, PhD, RN. 

Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center acknowledged the responsibility of the FDA regarding safety and efficacy in drug approvals in an interview with The Center for Biosimilars

Abraham does not advocate for adopting the World Health Organization (WHO) guidelines entirely but sees promise in recent FDA movements on interchangeability since they propose the use of statistical modeling and shifting the clinical evidence burden to post-approval safety monitoring to expedite approval.

This transcript has been lightly edited for clarity. 

What specific regulatory roadblocks are hindering the rapid approval of biosimilars, and how can we collaborate with regulatory bodies to streamline the process? 

What we need to remember is that the FDA is the watchdog for everything that is related to drugs. It has an enormous responsibility and accountability, also to Congress, in terms of providing safe—in first instance—and then also effective drugs and that applies to biosimilars as well.

In a certain way, I expect the changes in terms of approval processes, and market entry, and post-approval monitoring will gradually, in an incremental way, stepwise, loosen up, for lack of a better word. So, biosimilar approval 2.0 will emerge at some point in time.

I'm not ready to be quoted saying that the FDA should adopt the WHO guidelines because the influence of the FDA and the European Medicines Agency (EMA) is global. Yes, we need to provide access to biosimilars in the rest of the world as well, but it needs to come from a very high level of standards related to quality and equivalence.

If you look, for instance, at issues—and that's an area where we see some movements within the FDA, and that has to do with interchangeability—there's a recent document that came out, and getting the interchangeability may, at some point in time, become a lot easier.

It can actually be done much easier because interchangeability can be modeled statistically. We have developed—while it's still in the prototype phase—a model that you could statistically create scenarios of interchangeability, take the data that are available, whether they're just pre-approval data, whether they're real-world clinical data, safety and effectiveness data, and model whether there is a risk and what that risk is of an adverse outcome related to interchangeable use of biosimilars.

It's also important then to shift the clinical evidence burden to safety post-approval. We can accelerate the process, for instance, as we do for some other drugs, and say, "Okay, we'll approve your biosimilar, but you are going to be watching yourself and reporting data to us based upon your biosimilars." In that process to develop—and I think that it is critical to develop channels for post-approval monitoring that go beyond voluntary reporting—make it required for the first 2 years on the market.

It doesn't mean that biosimilar companies would need to start sponsoring post-approval prospective studies or whatever because those are expensive. But you can do that to some extent with claims databases, electronic health records, to see what pops up in terms of safety signals as we use biosimilars.

Ivo Abraham, PhD, RN, University of Arizona Cancer Center, recognizes the importance of stringent safety measures for biosimilar approvals. However, he advocates for utilizing statistical models and placing emphasis on postmarket safety data collection.

Streamlining Biosimilar Approvals by Balancing Safety, Speed

The Top 5 Biosimilar Articles for the Week of July 22

 Samsung Bioepis’ Epysqli (eculizumab-aagh), marking the second US approval for a biosimilar referencing Soliris (eculizumab).

 or chronic inflammatory rheumatic disease treated with reference adalimumab who were switched to the 

 CT-P17 generally believed the switch was a treatment necessity. Higher satisfaction rates were observed among those who were convinced of the necessity compared with those with greater concerns about treatment.

 aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.

challenges with pharmacy benefit managers

 (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.

Economic evaluations of biosimilar disease-modifying antirheumatic drugs (DMARDs) suggest cost-effectiveness for patients with rheumatoid arthritis (RA) who did not respond well to methotrexate, potentially 

improving patient outcomes and health care affordability.

Here are the top 5 biosimilar articles for the week of July 22, 2024. 

The Top 5 Biosimilar Articles for the Week of July 15

, discusses how biosimilars can be part of a strategy for delivering high-quality care while achieving savings.

 Patients with HER2-positive breast cancer treated with the biosimilar 

 experienced similar adverse events and well-being as those treated with the originator drug (Herceptin), according to a study using a smartphone app to track symptoms.

biosimilar disease-modifying antirheumatic drugs (DMARDs)

 suggest cost-effectiveness for patients with rheumatoid arthritis (RA) who did not respond well to methotrexate, potentially improving patient outcomes and health care affordability.

 and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.

challenges with pharmacy benefit managers (PBMs)

 that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.

Here are the top 5 biosimilar articles for the week of July 15, 2024.

Jeffrey Casberg

Jeffrey Casberg, MS, RPh, senior vice president of pharmacy at 

, discussed the FDA approvals of new drugs and what these new launches could mean for drug pricing. He also spoke to the approach pharmacy and therapeutics committees take to reviewing new pipeline drugs.

What is your reaction to the FDA approval of the first denosumab biosimilars?

So denosumab biosimilars, there was 2 approved; 

Wyost [denosumab-bbdz] and Jubbonti [GP2411]

. The Jubbonti is for Prolia, the Wyost is for Xgeva. One is more oncology based, one is more osteoporosis based.

They were approved, but there's no announcement on when they're going to be launched. We're thinking they might even be delayed in launch till 2025. 

With only one manufacturer coming out, Sandoz, with both of those, we'll get some discount on the brand and reference drug but it's not going to be significant. It's not going to be like the 

Humira [adalimumab] situation with 9 or 10 biosimilars.

What are your thoughts on what the launch of the first tocilizumab biosimilar means for patients with autoimmune conditions?

 is actually IV [intravenous] and sub-q [subcutaneous]. I think that the 2 products launched, 

 is both IV and sub-q, and that's from Fresenius Kabi.

For the most part, Actemra is used in rheumatoid arthritis, a couple other conditions as well. Getting biosimilars in a different therapeutic area, including Actemra, that will be a big advancement. That's 2 biosimilars, so we will get a little competition there on pricing, but I don't know if I can predict what the discounts will be—maybe, 20% to 30% off.

How are pharmacy and therapeutics committees likely to approach new pipeline drugs, considering factors like efficacy, safety data, and potential cost compared to existing options?

P&T [pharmacy and therapeutic] committees are pretty standard in their approach on how they review drugs for formulary inclusion. It really comes down to safety, cost, and efficacy.

I think in today's world, the only difference is that there's a lot of these new orphan drugs which don't have a lot of competitors, so the P&T committees have to look at a drug on its own or a small number of patients, so they really look at the efficacy opportunity—which patients should get the drug, and what the criteria can be.

It's a lot less managing 4 or 5 drugs in a therapeutic area and comparing the pros and cons of drugs that are very similar. Nowadays, we're comparing a million-dollar drug which has no competition and who the patient should be and what the criteria should be. So there is a little shift in reviewing drugs from multiple drugs in 1 therapeutic class to orphan drugs.

Jeffrey Casberg, MS, RPh, senior vice president of pharmacy at IPD Analytics, highlights new FDA approvals, the launch of the first tocilizumab biosimilar, and how pharmacy and therapeutics committees approach new pipeline drugs.