Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

Here are the top 5 biosimilar articles for the week of October 28, 2024. 

: At the GRx+Biosims conference, a fireside chat highlighted the need to 

streamline biosimilar development and strengthen industry collaboration

, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.

: Regulatory experts and representatives from some of the top biosimilar manufacturers emphasized the importance of global harmonization and streamlining biosimilar development 

, panelists explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.

: During a fireside chat at GRx+Biosims, FDA Commissioner Robert Califf, MD, shared his perspective on key challenges and sustainability concerns in the generic drug industry, touching on pressing issues within the 

US health care system and broader global supply chain vulnerabilities

 key insights into biosimilar device requirements, emphasizing risk analysis, human factors studies, and alternative validation approaches to streamline regulatory approval for interchangeable biosimilars, while maintaining patient safety and efficacy, at the 

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of October 28

Here are the top 5 biosimilar articles for the week of October 21, 2024. 

overview of the current biosimilar education material

 offered by the FDA, emphasizing that manufacturer-developed materials aren't needed.

 will offer an adalimumab biosimilar at a price that is 75% less than the reference product Humira for the monthly dose.

 after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.

: The European Union's (EU) approach to biosimilars has revolutionized the 

 by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.

, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the importance of local market understanding, and the role of technology in enhancing submission efficiency.

Here are the top 5 biosimilar articles for the week of October 21, 2024.

The Top 5 Biosimilar Articles for the Week of October 21

Here are the top 5 biosimilar articles for the week of October 14, 2024. 

 Imuldosa (ustekinumab-srlf), a biosimilar referencing Stelara (ustekinumab), for the treatment of autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

 emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.

Transformative cell and gene therapies (CGT)

 offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.

: A study found that switching from rituximab to 

 is safe and effective for patients with systemic lupus erythematosus (SLE).

The Top 5 Biosimilar Articles for the Week of October 14

This was originally published on The American Journal of Managed Care

The adalimumab biosimilar Idacio (adalimumab-aacf) will be available to beneficiaries of Blue Shield of California at a steep reduction over the price of the reference product (Humira), which treats patients with inflammatory diseases.1 The biosimilar will be purchased at a net price of $525 per monthly dose compared with the $2100 net market price for the originator.

Blue Shield of California will offer an adalimumab biosimilar at a price that is 75% less than the reference product Humira for the monthly dose. | Image credit: gopixa - stock.adobe.com

Over the past 2 decades, more than 300,000 Americans used adalimumab annually. Blue Shield of California reported processing an estimated 40,000 adalimumab prescriptions every year, making it necessary to find an alternative option that is affordable.

“We will no longer take part in a pharmacy system that is designed to maximize the profit of participants instead of the quality, convenience and cost-effectiveness for consumers,” Paul Markovich, CEO of Blue Shield of California, said in a statement.

Fresenius Kabi and Evio Pharmacy Solutions partnered with Blue Shield of California to facilitate cost reductions and were able to eliminate the price markups applied in traditional pharmacy benefit manager (PBM) models. Instead, Blue Shield of California asserts that its new Pharmacy Care Reimagined model will offer patients better access to biosimilars.

The collaboration between the 3 stakeholders led to agreements on aligned incentives and the removal of excess complexities that has allowed the adoption of lower-cost medications despite supply chain shortages. Nearly all patients with Blue Shield who take Fresenius Kabi’s adalimumab-aacf will pay $0 out of pocket, beginning January 1, 2025, which could help improve medication adherence.

Evio Pharmacy Solutions, a pharmacy solutions startup founded by the Blues, is directly purchasing Idacio from Fresenius Kabi in a model that is designed to minimize net costs and create transparency.2

The growing number of biosimilar drugs is increasing price transparency in the market. This is evident with the recent launch of several adalimumab biosimilars, including adalimumab-atto (Amjevita) in the US.3 Amgen, the manufacturer, applied a pricing strategy that offers discounts based on patient insurance coverage and has contributed to a steady decline in the market share of the original drug, Humira.

“Humira has drawn scrutiny for its high and inconsistent pricing from both consumers and policymakers,” said Matt Gibbs, vice president of pharmacy transformation at Blue Shield of California.1

The Biosimilars Council revealed in an analysis from this past year that both patients and health plans were missing out on billions of savings because of PBM rebate policies.4 The analysis found Humira was costing patients, employers, and health plans around $700 million in increased drug costs and fees for each month since the launch of the first biosimilar.

The Biosimilars Council is pushing for the FDA to streamline its regulatory procedures for biosimilars.5 They believe regulations are unnecessary when there are no clinical differences between a biosimilar and its reference product.

“The time is now to update and streamline the current regulatory model for biosimilars,” stated Craig Burton, executive director of the Biosimilars Council. “Around 80% of biologics currently do not have a biosimilar product in the works. Let’s reduce that percentage and pave the way for a new generation of lower-cost medications.”

Blue Shield of California slashes cost of world’s best-selling drug. Blue Shield of California. News release. October 1, 2024. Accessed October 2, 2024. 

https://news.blueshieldca.com/2024/10/01/blue-shield-of-california-slashes-cost-of-worlds-best-selling-drug

Evio announces groundbreaking direct purchase agreement for adalimumab biosimilar. Evio Pharmacy Solutions. News release. October 1, 2024. Accessed October 4, 2024. 

https://www.prnewswire.com/news-releases/evio-announces-groundbreaking-direct-purchase-agreement-for-adalimumab-biosimilar-302263346.html

Joszt L. Biosimilar competition erodes Humira’s market share; Amjevita leads the pack. 

. September 22, 2023. Accessed October 7, 2024. 

https://www.ajmc.com/view/biosimilar-competition-erodes-humira-s-market-share-amjevita-leads-the-pack

Jeremias S. Biosimilars Council: PBM rebate schemes cost Americans, payers $6 Billion. The Center for Biosimilars

. April 10, 2024. Accessed October 3, 2024. 

https://www.centerforbiosimilars.com/view/biosimilars-council-pbm-rebate-schemes-cost-americans-payers-6-billion

Jeremias S. Biosimilars Council position paper calls for end to clinical efficacy trials for biosimilars. The Center for Biosimilars. June 4, 2024. Accessed October 7, 2024. 

https://www.centerforbiosimilars.com/view/biosimilars-council-position-paper-calls-for-end-to-clinical-efficacy-trials-for-biosimilars

Articles

Blue Shield of California will offer an adalimumab biosimilar at a price that is 75% less than the reference product Humira for the monthly dose.

Blue Shield of California Lowers Humira Biosimilar Costs, Challenges PBM Pricing

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, recalls when he first began biosimilar research in the US in an interview with The Center for Biosimilars

Abraham emphasizes the current challenges that prevent greater biosimilar uptake and discusses techniques manufacturers can use to initiate more affordable drugs. He also mentions the doubts many expressed in the early years of biosimilar development.

This transcript has been lightly edited for clarity.

What are some of the challenges that biosimilar companies face when gaining market acceptance in the US? How have they been addressed?

We're going see more developments in terms of how biosimilars will be on the market. The detailing approach has not worked. The early days of biosimilars in the US, going from place to place trying to sell your biosimilar, that is too expensive; you cannot afford that.

There are some very interesting developments. For example, Cordavis, which is under CVS and a biosimilar company that they are aligned with. If you look at the Marc Cuban Cost Plus Drug pharmacy, they have certain agreements. Manufacturers of biosimilars need to continue getting volume contracts to stay active on the market.

To be honest, Gary [Lyman, MD, MPH, oncologist, hematologist, and public health researcher] and I took a big gamble in 2007; we had been doing work in biologics and growth factors internationally since 1998. The people that we've worked with at J&J [Johnson & Johnson], Roche, Amgen, and so on were then being recruited by the biosimilar manufacturers. Then they literally called us up and said, "Can you help us out?” I remember Gary and I were talking, thinking, this could be big.

I also know that some people said, "They must not be doing well since they're doing generics now." For us, it's really been the goal from the beginning to increase access, then we started formulating that more recently into equity, and that is what generics, biosimilars, and bioparallels are.

Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center, discusses the potential of biosimilars and challenges in the US, emphasizing partnerships for market growth.

From Skepticism to Success: Insights Into Biosimilar Market Acceptance

Here are the top 5 biosimilar articles for the week of October 7, 2024. 

 of a mandatory nonmedical switch in Canada found no significant differences in rates of treatment persistence, loss of response, or adverse events in patients with inflammatory bowel disease (IBD) on maintenance therapy 1 year post-switch.

, the FDA approved a new biosimilar for treating retinal conditions, marking a significant development in the biosimilars landscape, coinciding with ongoing legal disputes in the industry and highlighting broader trends in market dynamics and regulatory challenges.

 a new strength of a trastuzumab biosimilar; UnitedHealth will remove reference adalimumab from some preferred drug lists in favor of biosimilars and Evernorth will offer an interchangeable ustekinumab biosimilar at no cost to patients; Samsung Bioepis received a positive regulatory opinion for its aflibercept biosimilar.

 these entrenched market dynamics, they must not only compete on price but actively work to build a network of support among providers and patients.

 was approved simultaneously in the European Union. In the US, it will launch in February 2025.

The Top 5 Biosimilar Articles for the Week of October 7

A study found that switching from rituximab to biosimilar CT-P10 is safe and effective for patients with systemic lupus erythematosus (SLE). | Image Credit: luchschenF - stock.adobe.com

Switching from originator rituximab to biosimilar rituximab (CT-P10) was found to be safe and effective in patients with systemic lupus erythematosus (SLE), according to a study published in the 

European Review for Medical and Pharmacological Sciences

SLE can be defined as an autoimmune disease where the body attacks healthy tissue, impacting the skin, joints, kidneys, brain, and other organs.

 Epidemiology of SLE is not quite clear but evidence suggests the condition is associated with genetics, environmental factors, hormones, and medications. Symptoms of SLE can vary widely, but often include joint pain, fatigue, skin rashes, and fever.

Treatment for SLE ranges but widespread evidence has found decreased B-cell counts result in positive effects through the induction of T cells that leads to the production of cytokines.

 The originator rituximab was developed to induce apoptosis of B cells by killing B cells mediated by complement and antibody dependent cellular cytotoxicity by antagonizing CD20.

Celltrion developed the first rituximab biosimilar, and it received approval in 2017 by the European Medicines Agency (EMA).

 The drug was originally made to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis. This was the first biosimilar to receive market approval from the EMA and its usage approval is available for all indications of originator rituximab.

“The objective of our study was to analyze the efficacy and safety data of treatments with originator rituximab and CT-P10 molecules intra-comparatively,” the study authors stated.

Disease activity was assessed with the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K). SLEDAI-2K is a weighted scoring system that accounts for various clinical and laboratory factors associated with SLE to assess disease activity.

Most patients were female (86.4%), and they had a mean (SD) age of 40.3 (10.6) years. Treatment duration was 35.6 (23.0) months for the originator and 17 months for CT-P10. More than half of the patient population had at least 1 comorbidity present (68.2%), the most common being hypertension (63.6%).

The kidney was considered the most frequently involved organ (63.6%), and ischemic cerebrovascular accident was the most common neurological involvement pattern (22.7%).

SLEDAI-2K scores were 2 and 0, respectively, approximately 3 months before and after the administration of the first dose of biosimilar CT-P10. The SLEDAI-2K scores of the rituximab biosimilar represented a statistically significant difference (

 = .027). Three months after the first dose of CT-P10, the SLEDAI-2K score was significantly lower. The analysis identified differences between the SLEDAI-2K score 3 months after the last dose of the originator (median, 2.5) and the score found in patients around 3 months after the first dose of the biosimilar (median, 0.0) (

The rituximab originator had an adverse effect frequency during administration of 15.3 per 100 patient-years. Urinary tract infections were of the most common infections contracted (7.7 per 100 patient-years).

During administration of the biosimilar, the adverse effect frequency was 39 per 100 patient-years. Pneumonia was the most common infection among patients, at 19.5 per 100 patient-years.

The limited number of participants and study design limited the results. The duration of follow-up after switching to the biosimilar was shorter than the originator. The study also did not include a control group, and most patients were not in flare during the efficacy evaluation. The COVID-19 pandemic coincided with the time interval of switching.

Ekin A, Mısırcı S, Coşkun BN, Yağız B, Dalkılıç E, Pehlivan Y. The retrospective evaluation of efficacy and safety data after switching from originator rituximab to biosimilar rituximab (CT-P10) in patients diagnosed with systemic lupus erythematosus: a single-center experience. 

. 2024;28(10):3513-3522. doi:10.26355/eurrev_202405_36286

Systemic lupus erythematosus. MedlinePlus Medical Encyclopedia. 2018. Accessed October 3, 2024. 

https://medlineplus.gov/ency/article/000435.htm

Biosimilar approvals. The Center for Biosimilars

. Updated March 22, 2024. Accessed October 3, 2024. 

https://www.centerforbiosimilars.com/biosimilar-approvals

A study found that switching from rituximab to biosimilar CT-P10 is safe and effective for patients with systemic lupus erythematosus (SLE).

Biosimilar Rituximab Safe, Effective for SLE After Switching

Here are the top 5 biosimilar articles for the week of September 30, 2024.

 written by Vibeke Strand, MD, clinical professor in division of immunology/rheumatology at Stanford University School of Medicine, gave an overview of patient-reported outcomes (PROs) in the VOLTAIRE-RA trial.

 diving into the Association for Accessible Medicines' (AAM) latest report discusses that while generics and biosimilars saved $445 billion in 2023, their potential is hindered by high patient costs, drug shortages, and ineffective policies, underscoring the need for reforms to fully realize their benefits.

approved Celltrion's ustekinumab biosimilar

 for chronic inflammatory diseases, Celltrion expanded access to Zymfentra (subcutaneous infliximab-dyyb) through partnerships with Cigna and Express Scripts, and the Association for Accessible Medicines held a policy briefing addressing barriers to biosimilar adoption.

: The Inflation Reduction Act (IRA) has modestly boosted 

 through Medicare reimbursement, but its impact has been limited due to preexisting competitive market conditions.

The Top 5 Biosimilar Articles for the Week of September 30

Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center, discusses the evolvement of the biosimilar landscape throughout the years in an interview with The Center for Biosimilars®.


Abraham addresses both biosimilars and generics, highlighting their potential to provide more access to patients at lower costs while recognizing the challenges of marketing biosimilars and the need for volume contracts to stay competitive.

This transcript was lightly edited for clarity.

The biosimilar landscape is constantly evolving. What emerging trends in health economics or clinical research do you see impacting the future of biosimilar development and access?

Price erosion is one because it can only go so low. We need to make sure that this does not threaten the biosimilar manufacturing side of the formulary. They have more costs to recover, so there needs to be some way, and it's probably going be more of a coordinated way of limiting the price erosion that we see for the reference products. We know a lot of those costs have already been recouped, whereas a biosimilar company still has to do that. Also, we are seeing the high volume agents that the manufacturer or the reference product is willing to go very, very low in terms of their price because it's made up in part by volume. That's an important aspect.

The other aspect that we need to take into account is we're not going to have influence over which biosimilar you're administered. It's the same thing as with a generic. You can go to the pharmacy and receive a 3-month supply from one company, and 3 months later, it may be another company just because your payer has different contracts or your pharmacy provider.

Dealing with the fact that we're talking about commodity markets, and as we've seen shortages in generic cancer drugs, for instance, manufacturers of generics are pulling out of producing certain treatments because of the margin being so minimal. This is not treating hypertensive patients, where you have millions and millions and millions. Just in the US, you may be talking about a much smaller patient population.

Another thing that is important is that, in the US, we need to let go of our xenophobism, that things that come from abroad are not good. When we talk about biosimilars, we're going to have to take into account that we have now entered also an era of bioparallels. These are products developed somewhere else, are of very high quality, very well researched, with clinical trials and so on, and will enter the US market or are entering the US market at a significant price discount relative to other very well-established products—and I'm referring to PD1 inhibitors—and will provide more access to more patients at potentially lower cost.

What we also need to take into account is that especially the manufacturers of biosimilars that also manufacture generics bundle their products. For instance, have a bundle of chemotherapy agents, not biologic agents, but chemotherapy agents with then a biosimilar of a biological product.

For instance, the first line of breast cancer treatment is highly myelotoxic. Patients are at very high risk of developing neutropenia or febrile neutropenia. Why not, as a manufacturer of generics and biosimilars, create a breast cancer bundle of products? Then the products could be priced accordingly and be sold to payers, providers, and patients.

Ivo Abraham, PhD, RN, University of Arizona Cancer Center, explains how biosimilars are becoming more accessible but face challenges like price erosion and potential shortages.

Future Biosimilar Trends, Challenges, and Opportunities

Here are the top 5 biosimilar articles for the week of September 23, 2024. 

 assessing patient satisfaction with adalimumab for inflammatory bowel disease (IBD) reported a high level of satisfaction with all adalimumab product, including biosimilars.

 with chemotherapy was effective in treating HER2-positive breast cancer, offering high safety and affordability.

: The article by Sarfaraz K. Niazi, PhD, critiques the irrationality surrounding biosimilars, suggesting that 

 in manufacturing could make biosimilars as affordable as generic drugs.

: Savings from generic and biosimilar drugs totaled $445 billion in 2023, showing promise for the growth of both markets and highlighting the success of expansion policies for these products, according to a new report from the 

: Amgen’s Pavblu (aflibercept-ayyh) is the 

 referencing Eylea (aflibercept) to be approved for American patients with retinal diseases.