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Connor Iapoce is an associate editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Articles

Released on March 21, the new scientific statement suggests supervised exercise training is safe and may offer substantial improvement in exercise capacity and quality of life, even more than medications, for many patients with heart failure. 

AHA/ACC Scientific Statement Reports Benefit of Supervised Exercise Training for HFpEF

. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with 

. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

Clinical remission and clinical response odds, in both induction and maintenance periods, have been consistent over time.



No Clear Patterns Emerging in Crohn’s Disease Treatment Outcomes in Recent Years

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

The US FDA has approved an indication for evinacumab for use as an adjunct to other lipid-lowering therapies in children with homozygous familial hypercholesterolemia as young as 5 years old, which makes evinacumab the first ANGPTL3 inhibitor indicted for this patient population.

FDA Approves Evinacumab for HoFH in Children Aged 5-11 Years Old

No single biomarker or multimarker score significantly reached the predefined acceptability thresholds for patients with NASH and clinically significant fibrosis.

Single Biomarker, Multimarkers do not Enhance Accuracy in Detecting NASH, Fibrosis

HCPLive is a comprehensive clinical news and information portal that provides physicians with up-to-date specialty and disease-specific resources designed to help them provide better care to patients. At HCPLive, you will find breaking news, video interviews with physician experts, in-depth conference coverage, finance and practice management updates, insight and analysis from physician contributors, and more.

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clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Clinical Topics

At the 6-month mark, there were no significant differences between the treatment groups regarding composite score-defined remission.

Adalimumab Biosimilar Shows Similar Efficacy, Safety Compared with Original in Rheumatoid Arthritis Treatment

Data from the United Kingdom indicate Amgevita is safe and effective for non-infectious uveitis with non-inferiority to originator adalimumab, but a significant number of patients requested to switch back due to adverse events. 

Adalimumab Biosimilar for Uveitis Similarly Efficacious to Bio-Originator

The approval was based on positive results from the phase I pharmacokinetics bridging study, which showed comparable PK and similar safety and immunogenicity of adalimumab 50 mg/mL and adalimumab high-concentration formulation.

FDA Approves High-Concentration Formulation Biosimilar Adalimumab-Adaz

In the infliximab reference group, the persistence at month 12 was 94% for Crohn’s disease and 92.8% for ulcerative colitis.

Infliximab Biosimilar Safe, Efficacious for Patients with IBD

No sign of harmful impacts related to the mandatory biosimilar switching policy for patients with inflammatory bowel diseases treated with infliximab was observed in the cohort study. 

Nonmedical Switching to Infliximab Biosimilar did not Negatively Impact Patient Health

As more biosimilars come to the market, there will be more questions to be answered and it is important to stay up to date on these developments. Bruce Feinberg, DO, Vice President and Chief Medical Officer at Cardinal Health, sat down with 

 and the steps being taken to monitor the trends in biosimilar uptake moving forward.

Feinberg explained that he and his team are constantly examining the market and the various influences that impact it. For example, the Oncology Care Model was a pilot program launched by the Centers for Medicare and Medicaid Services (CMS) that treated nearly 50% of Medicare beneficiaries with cancer in the last 5 years. The model was sunset and will be replaced by the Enhanced Oncology model (EOM), which will be less robust and impact a lower percentage of Medicare patients. Feinberg wondered how this new model will impact the utilization of biosimilars.

Biosimilars are deemed equivalent, or non-inferior, to the original product, but have been minimally tested to prove their equivalence. Policy can be a driver to increase the use of biosimilars. However, there are questions about how policy changes will impact prices and if those savings will be passed on to patients.

“The greatest incentive to biosimilar utilization has been the economic argument that if we can produce a product that is equivalent at a 20% or 30% lower cost, why isn't that enough of a driver for its use?” Feinberg said.

It is crucial to understand the methodological approach taken in research, as not all evidence is equal. The research conducted by Cardinal Health includes statistical analysis of different cohorts, which allows for a deeper understanding of the differences between specialty positions.

“The depth of inquiry that we do, the size and scale of the nature of the research, differentiates us from [other research], which is often less substantive and therefore less reliable,” Feinberg concluded.

 Bruce Feinberg, DO, is the Vice President and Chief Medical Officer at Cardinal Health

Bruce Feinberg, DO, explained that he and his team at Cardinal Health are constantly examining the market and the various influences that impact biosimilar uptake. 

Bruce Feinberg, DO: Continuing to Monitor Biosimilar Trends Through Research 

, published earlier this year, described the opinions of physicians across specialties, including rheumatology, dermatology, ophthalmology, and gastroenterology, regarding the experience of and level of comfortability associated with prescribing biosimilars.

Biologics are more expensive due to the extensive research required to prove their safety and efficacy. Although biosimilars undergo rigorous testing, they are not as rigorous as the original biologics. Bruce Feinberg, DO, Vice President and Chief Medical Officer at Cardinal Health, used adalimumab as an example, explaining that while the drug has 6 major disease indications, a biosimilar only has to prove itself in one indication, without a head-to-head comparison. In some cases, biosimilars may not have the same level of evidence in the disease state in which they are used, leading to reluctance among physicians with less experience or availability of biosimilars to prescribe them.

Despite this hesitancy, Feinberg believed the responses from providers, which showed that specialties with more biosimilar availability and exposure were more likely to recommend biosimilars to their patients, was predictable.

“I don't like to think that physicians in different specialties act differently. These are all medical specialties… It’s reassuring to me that as rheumatologists gained as much experience as oncologists had with this class of drug, their behaviors matched oncologists in terms of their willingness to prescribe in almost any clinical scenario.”

He noted that the one area that still poses a problem is the idea of switching to another treatment when a patient is having an excellent response to the reference drug. Even though biosimilars have been deemed equivalent to their reference products, prescribers may be wary of switching patients to a different product. Feinberg stated that this uncertainty is not unique to biosimilars and has also been seen with generics.

“[Patients and prescribers] know that there is no reason why it won't work the same,” Feinberg emphasized. “[However], we work both in our brain and our heart. When you're attached to a product because it's given you a dramatic improvement in quality of life or length of life, it’s hard to want to make a switch of any kind.” 

Bruce Feinberg, DO, noted that although patients and providers ultimately understand that a biosimilar should theoretically be just as effective as a biologic, prescribers may still be wary of switching patients to a different product when they have historically experienced an excellent response to the original treatment. 

Bruce Feinberg, DO: Common Hesitancies Observed Among Providers Switching to Biosimilars

Cardinal Health surveyed over 350 providers spanning rheumatology, dermatology, gastroenterology, and ophthalmology to better understand the changing landscape of the industry and the market shifts that are continuing to occur given the expansion of biosimilars. Results were compiled in the 

, Bruce Feinberg, DO, Vice President and Chief Medical Officer at Cardinal Health, explained the how Cardinal Health is focusing on understanding and engaging with all sectors of the healthcare economy, including providers, payers, patients, and biopharma manufacturers.

Feinberg views the variations in adoption of biosimilars by different physician specialties as a scientific question to investigate.

“As we've looked at oncologists, rheumatologists, and now expanding that to gastrointestinal doctors and dermatologists, we see very different levels of up embrace and adoption,” Feinberg noted. “And it seems that those levels are directly related to the amount of experience those physicians have had with the products that were available and the number of products available, not just the individual biosimilar but how many types of reference brands have biosimilars.”

Results indicated that physicians who have more experience with biosimilars and a greater variety of reference brands with biosimilars available tend to have higher levels of acceptance and adoption. For instance, in oncology, where there are many biosimilars and policies like the Oncology Care Model that encourage their use, there has been a much higher adoption rate. Rheumatology is following a similar trajectory as oncology, while gastroenterology and dermatology, which have had less exposure to biosimilars, have lower adoption rates.

Cardinal Health is also seeing the impact of policy on prescribing patterns, which adds another layer of complexity to the analysis. By looking at factors, including exposure and patient complexity, they can start to identify patterns and gain insights into the different levels of adoption across specialties.

Bruce Feinberg, DO, explained how Cardinal Health used its 2023 Biosimilars Report to better understand the provider's insight on industry changes that are occurring due to the expansion of biosimilars. 

Bruce Feinberg, DO: Differences Among Specialties in Biosimilar Uptake 

 the biosimilar adalimumab-aacf (Idacio), a citrate-free formulation of adalimumab. In an interview with 

, Brandee Pappalardo, PhD, Senior Vice President and Chief Medical Officer, US Medical Affairs, at Fresenius Kabi, spoke about the newly approved biosimilar and what this means for the future of treatment for patients with rheumatic diseases and the clinicians tasked with choosing the right drug. The tumor necrosis factor (TNF) inhibitor is set to launch commercially in the US in a self-administered prefilled syringe and a self-administered pre-filled pen in July 2023.

“The approval is the signal in the beginning of kicking off what we know is going to be a very long-term dedication to biosimilars,” Pappalardo stated. “This is something we are incredibly committed to.”

Pappalardo emphasized the difficulties of getting biosimilars to market in the United States. However, the benefits of incorporating biosimilars are clear, including increasing access to the drug and the cost-saving implications across the healthcare industry.

“Particularly with rheumatic diseases, if you treat them early, you can prevent joint degradation, bone degradation, and those patients can have a better quality of life,” Pappalardo started. “But they've got to get that drug at the right time.”

The approval of adalimumab-aacf was based on comprehensive data, including clinical trials in psoriasis and rheumatoid arthritis, which demonstrated a similar analytical profile, safety, efficacy, and immunogenicity to the reference adalimumab product.

Correction: Cost-savings are projected to be $100 billion by 2025, not $1 billion as stated by Pappalardo. 

The approval of the adalimumab biosimilar, adalimumab-aacf, signals the beginning of Fresenius Kabi's long-term dedication to biosimilars.


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