The Top 5 Biosimilar Articles for the Week of July 8

As the weather heats up for the US and Europe, so too did the 

, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.

 As Celltrion publishes phase 3 data on its tocilizumab biosimilar, other companies finalize partnerships, and Formycon 

 to receive approval for the American market. It was also approved with interchangeability.

FDA has approved Ahzantive (aflibercept-mrbb)

 as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration.

 to remove switching study data for companies seeking to obtain an interchangeability designation for their biosimilars.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of July 8, 2024.

Here are the top 5 biosimilar articles for the week of July 1, 2024. 

The Top 5 Biosimilar Articles for the Week of July 1

 for the treatment of inflammatory conditions, including plaque psoriasis and ulcerative colitis.

, 1 in Crohn disease (CD), and 1 in ulcerative colitis (UC), found 

 in patients treated with the subcutaneous formulation of infliximab biosimilar CT-P13 (Remsima, Inflectra; Celltrion) compared with placebo as maintenance therapy following an induction phase of intravenous CT-P13.

Key findings showed that there continues to be a lack of understanding and/or confidence in biosimilars 

, leading to diminished provider willingness to prescribe biosimilars and patient perceptions about the safety of switching to a biosimilar.

Here are the top 5 biosimilar articles for the week of July 1, 2024.

Jeffrey Casberg Q3

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

, considers the top 3 promising biosimilars currently coming down the pipeline. He addresses the significance  of each and the specific areas of health they treat.

He also touches on the FDA Advisory Committee and speaks about the obstacles that have delayed approvals for these medications.

This transcript has been lightly edited for clarity.

In your view, what are the top 3 promising specialty drugs currently coming down the pipeline and why should stakeholders be keeping an eye on them?

The first one I'll talk about is donanemab for Alzheimer's disease by 

; it's an amyloid-β inhibitor for early Alzheimer's disease. It would be a little bit different than 

 from Biogen, which was fully approved more recently.

Donanemab was originally going to be approved beginning of 2023, so over a year ago, but it has had a little bit of a storied pathway to approval. We were watching for an approval here any day during this last month or so, then out of the blue, there was an announcement that the FDA has requested an 

If I'm a manufacturer, not really happy about that; you never really want extra scrutiny on your drug. I'm sure they're going to talk about the dosing regimen, the potential for shorter duration of therapy compared to Leqembi probably the ARIA [amyloid-related imaging abnormalities] side effect profile. They haven't given us a date for that FDA Advisory Committee meeting. I would anticipate a date being announced any day and I still think there's opportunity for approval before the end of 2024.

I think one of the other products that is exciting is resmetirom, or Rezdiffra. for NASH [nonalcoholic steatohepatitis]. First product approved for NASH. Again, a therapeutic area we've been waiting for therapies now for maybe 10 years. Finally we do have an approval. Congratulations to 

 on that, getting their product over the finish line.

A once daily, oral product. It showed signs of efficacy and NASH resolution and fibrosis improvement. Prescribing information did not include discussion of the need for biopsy in diagnosis. So, to diagnose NASH, now called MASH [metabolic dysfunction-associated steatohepatitis], the gold standard is liver biopsy, but that's pretty invasive. You can also use noninvasive therapy testing to get diagnosis of staging of NASH in the liver. They did not have that, which was a plus for Madrigal.

It would be interesting to see how the payers set up their criteria for approval. There's a whole lot of population out there that could be treated with this, so that's another big approval that just occurred. 

I'll just mention one other recent approval. It's called 

 for pulmonary arterial hypertension, sotatercept, by Merck. Winrevair is the brand name.

It's a new product for PAH, pulmonary arterial hypertension. It's a new mechanism of action, and has the potential to be more disease modifying—the other therapies out there are more symptomatic treatments—and probably early on will be used as add-on or [in the] second or third line. But I think as physicians get used to it, they could move it up in therapy.

It is pretty expensive: $240,000 for most patients, could be $480,000 for some patients. It's a weight-based dosing, so 1 vial or 2 vials. I think it's subcutaneous every 3 weeks, and it can be self-administered or professionally administered.

In an interview with Jeffrey Casberg, MS, RPh, he discusses 3 promising specialty drugs coming through the pipeline. Casberg explains these drugs offer new treatment options for major diseases and stakeholders should watch for their potential impact on the market.

Jeffrey Casberg of IPD Analytics Gives Insight on Specialty Drugs in the Pipeline

Here are the top 5 biosimilar articles for the week of June 24, 2024. 

British Columbia's Biosimilars Initiative

 successfully saved about $732 million over 5 years by switching over 40,000 patients from reference biologics to biosimilars, while maintaining equivalent health outcomes and reinvesting the savings into the province's public payer program (BC PharmaCare) to enhance drug coverage and health care services.

 Sarfaraz K. Niazi, PhD, makes suggestions for what arguments will help 

convince the FDA to waive clinical efficacy testing requirements

 has the potential to significantly reduce cancer care costs and improve patient access to more affordable treatments, benefiting both patients and payers. However, a recent review highlights that biosimilar uptake has been hindered by various economic, practical, attitudinal, and psychological factors.

 of this series installment by The Center for Biosimilars®, the role of payers, pharmacy benefit managers (PBMs), and the financial incentives that influence prescription choices are addressed as obstacles towards affordable biosimilar treatments, specifically among underserved communities.

 to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.

Here are the top 5 biosimilar articles for the week of June 24, 2024.

The Top 5 Biosimilar Articles for the Week of June 24

IDP Analytics SVP Says IRA, PBM Legislature Reshape US Drug Costs

In an interview with Jeffrey Casberg, RPh, MS, senior vice president of pharmacy at 

, discussed policy changes and market forces that are impacting the cost of drugs. Casberg explained why he felt the Inflation Reduction Act (IRA) and pharmacy benefit manager (PBM) legislation are the most impactful.

He also touched on value-based pricing models. Although skeptical of value-based pricing being a universal solution, Casberg sees promise in its use for expensive drugs, like gene therapies, where outcomes can be more easily measured.

This transcript has been lightly edited for clarity. 

Do you foresee any policy changes or market forces that could significantly alter the cost landscape for both branded and generic drugs in the near future?

So policy or legislation, everything is about politics. I guess I'll mention 2 things. I'll mention the 

. Those would be the 2 hot ones on the IRA side, we just had the first release of the negotiated drugs and which drugs they are. We'll be getting 

, a new acronym for drug pricing, those will be announced coming up soon.

We're going to have the out-of-pocket cost of Part D reduced to the max of an out-of-pocket cost to $2,000. That's big for patients, impactful to manufacturers, and payers. Now they're going to have to deal with different benefit designs and how they're going to market the drug and price the drug or how payers are going to make the benefits work with the new $2,000 max, so there is something for everybody there.

Then 2025 redesign, for the Inflation Reduction Act, there's also quite a few different benefit designs changing for 2025. There's 

 so the manufacturers have to watch how much they're raising the prices of their drugs. If they go up too high, too quickly, then they get these penalties against them. The IRA has a number of different things, pretty complex, and everybody's paying attention to that.

Then on the second hand, it would be PBM legislation. I guess it depends on who you are and your feeling towards PBM legislation. I think it probably just comes down to more transparency. Every business has to make money and PBMs have done it. Somebody could argue they did it okay. Some say it was all smoke and mirrors but I think there's legislation now to have more transparency on PBMs. We'll see how that rolls out but a lot of discussion up in Washington on that these days.

Value-based pricing models are increasingly being explored. How do you think value-based pricing will impact the development, approval, and access to new drugs?

So value-based pricing, you hear a lot about it. You hear people trying to implement it, manufacturers bring proposals to payers on value-based pricing models. What we don't hear of are the results and if they are working or not.

I don't know in the long run, if value-based pricing will be the 'be all and end all' and change the way drugs are paid for in the United States. I'm going to say no but I think there's some value to value-based pricing and in how you look at drugs and evaluate them.

I think especially some of these high cost therapies have opportunities for some value-based models. As I was saying earlier, there's more and more of these high cost, really expensive products and looking at outcomes and measuring outcomes, that kind of thing are for these gene therapies and other expensive therapies.

I'm not saying value-based pricing will take over but I think there's opportunity in the future for use of them.

Jeffrey Casberg, RPh, MS, from IPD Analytics, explains why he believes policy changes and market forces are impacting the cost of drugs, including the Inflation Reduction Act (IRA) and pharmacy benefit manager (PBM) legislation.

IPD Analytics' Jeffrey Casberg Says IRA, PBM Legislation Reshape US Drug Costs

The Top 5 Biosimilar Articles for the Week of June 17

 A real-world study of children and young adults with inflammatory bowel disease (IBD) switched from the infliximab reference product to a biosimilar concluded 

 over 12 months based on stable remission rates and biochemical markers.

 with non-infectious uveitis from originator adalimumab to biosimilar adalimumab-atto was safe and effective, but some patients experienced the nocebo effect, where negative adverse events are caused by patients’ poor perception of the drug rather than the medication itself.

European Hematology Association’s (EHA) 2024

 annual meeting in Madrid, Spain, showed similar rates of transfusion avoidance between patients with paroxysmal nocturnal hemoglobinuria who were administered reference eculizumab (Soliris) and those administered an eculizumab biosimilar (SB12).

 British Columbia's 2019 Biosimilars Initiative, which transitioned over 40,000 patients from costly branded biologics to biosimilars, saved around 

, maintained comparable health outcomes, and reinvested the savings to improve the province's public payer program.

 Sarfaraz K. Niazi, PhD, makes suggestions for what arguments will help convince the FDA to waive 

Here are the top 5 biosimilar articles for the week of June 17, 2024.

Here are the top 5 biosimilar articles for the week of June 10, 2024. 

Researchers reviewed real-world evidence on the 

 of switching from tumor necrosis factor-α inhibitor originators to biosimilars in inflammatory bowel disease (IBD), prompted by mandatory switching policies in most Canadian provinces.

American Society of Clinical Oncology (ASCO) 2024

 annual meeting demonstrate positive safety and efficacy data for denosumab and pegfilgrastim biosimilars.

American and European regulatory agencies

 have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.

Sarfaraz K. Niazi, PhD, analyzes updates to the FDA's 

, as well as the agency's increased efforts to boost biosimilar adoption and education.

, part of the Association for Accessible Medicines, published a 

 advocating for updates to the FDA's regulatory process for biosimilars. The proposed changes aim to eliminate unnecessary regulatory requirements when no clinical difference exists between a biosimilar and its reference product.

Here are the top 5 biosimilar articles for the week of June 10, 2024.

The Top 5 Biosimilar Articles for the Week of June 10

Dr Lakesha Farmer Discusses Biosimilar Education

Lakesha Farmer, PharmD, MBA, senior director, strategic accounts, ION Oncology Practice Network at Cencora, outlined educational resources on biosimilars that are already available to patients as well as how her organization ensures that patients are aware of biosimilars and are comfortable with switching products.

Could you share insights into patient and provider education efforts regarding biosimilars, and how these efforts have evolved to address misconceptions or concerns?

So as we know, education is one of the most important factors in the acceptance and adoption of biosimilars for both providers and patients. When I was in practice as a pharmacy administrator, the largest misconception I faced was that biosimilar studies were inferior to their reference products' because they utilized extrapolation studies to gain approval for all indications. In my role as the director of pharmacy and co-chair of the P&T [pharmacy and therapeutics] committee, I was responsible for educating my providers and nursing staff on how extrapolated indications were granted by regulatory bodies and how critical quality and analytical attributes were used to establish scientific justifications for biosimilarity and FDA approval. 

Also, while I was in that role, I worked closely with our physician leaders and nursing administrators to create consent forms for patients who were being switched from a reference product to a biosimilar. We made sure that thorough education was provided to all patients to ensure that they were all well aware of what a biosimilar agent was and to set the expectation that they would still receive the same level of high quality care with their new agent. 

Outside of resources being created internally at the practice level, there have been several educational resources created for patients and providers by external organizations like manufacturers, distributors, medical professional organizations, as well as the FDA. 

Now that I'm out of clinical practice and have the opportunity to sit on the other side of the table as a distributor and GPO [group purchasing organization] partner, my organization, Cencora, has also contributed to making sure our patients and providers are well educated by creating several educational resources for our downstream and upstream customers that can be found in our biosimilar information hub.

From a patient-centered perspective, what are some of the most important considerations when promoting awareness and acceptance of biosimilars as viable treatment options?

So as we all know, patients are at the heart of what we do. So more patient-centered approaches to improving patient care and increasing cost savings directly to the patient is going to be paramount. You would think that because biosimilars are provided at a much lower cost to providers that the cost to patients would also be much lower. Well, unfortunately, that's not always the case. 

Although biosimilar competition decreases the cost of the health care system, this does not always translate to lower out-of-pocket costs, especially for commercially-insured patients. 

Therefore, this highlights the need for more patient-centric and targeted policy interventions to ensure that the savings generated from biosimilar competition translate into increased affordability directly to the patients who need affordable biologic agents for the treatment of their chronic and sometimes, unfortunately, life-threatening conditions.

Cencora's Lakesha Farmer, PharmD, MBA, discusses efforts that health care organizations can take to better educate patients and providers on biosimilars to improve biosimilar acceptance and achieve cost savings associated with these products.

Dr Lakesha Farmer Highlights Current Biosimilar Education, Acceptance Efforts

The Top 5 Biosimilar Articles for the Week of June 3

 (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability.

 of the use of adalimumab biosimilars in pediatric inflammatory bowel disease (IBD) in Sicily found “high rates” of clinical remission and treatment persistence, and no unexpected safety concerns.

 proved to be a big month for biosimilar research, particularly in the gastroenterology space, where new data on infliximab and adalimumab products from conferences and journals alike demonstrated positive clinical results showcasing the safety of these products as well as switching to them.

 evaluating switching patients from a biosimilar to another biosimilar revealed new data establishing the safety and efficacy of biosimilar-to-biosimilar switching.

Here are the top 5 biosimilar articles for the week of June 3, 2024. 

Here are the top 5 biosimilar articles for the week of May 27, 2024.

 Simlandi in the US; Xbrane Biopharma and STADA Arzneimitel partner with Valorum Biologics to bring a ranibizumab biosimilar to the US; Boehringer Ingelheim and Celltrion take steps to expand access to their respective adalimumab biosimilars.

 (DDW) on the ongoing LIBERTY-CD trial assessing Zymfentra, a subcutaneous infliximab product, compared with intravenous infliximab treatment in Crohn disease show the safety and efficacy of the product, as well as the impact of body mass index (BMI) on clinical outcomes.

Two posters from Digestive Disease Week found that switching patients with inflammatory bowel disease (IBD) from Remicade to an 

 did not impact clinical outcomes, with one study focusing on switches in pediatric patients and the other focusing on patients undergoing multiple switches.

Despite contributing significantly to reduced 

, biosimilars account for only about 23% of the overall biologics market, showing wide variation in uptake across different molecules, according to the IQVIA Use of Medicines in the US 

 the first 2 biosimilars referencing Eylea (aflibercept)—Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy)—for the treatment of ophthalmic conditions.