The Top 5 Biosimilar Articles for the Week of December 18, 2023

Number 5: After Humira’s patent expired in 2018 in the European Union (EU) and earlier this year in the US, 10 adalimumab biosimilars entered the market in the EU and 

 discussed the characteristics of the available biosimilars to help clinicians navigate the various options with their patients.

Number 4: Two Taiwanese posters from the 

San Antonio Breast Cancer Symposium (SABCS)

 2023 annual meeting evaluated the real-world implications of using trastuzumab biosimilars, particularly Ogivri (trastuzumab-dkst) in patients with HER2-postive breast cancer.

Number 3: Among patients with rheumatoid arthritis (RA) registered with the British Society for Rheumatology Biologics Register in Rheumatoid Arthritis (BSRBR-RA), those treated with 

 showed similar treatment responses and drug survival rates vs those treated with etanercept originator. The findings were published in 

 that can help patients, caregivers, and providers navigate decision-making and treatment conversations for multiple disease states.

FDA agreed to review an application for Hadlima

 (adalimumab biosimilar) to be granted interchangeability; The European Union’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for an ustekinumab biosimilar; the Biosimilars Forum expressed support for Senate Finance Committee’s draft legislation promoting biosimilars.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of December 18th, 2023. 

The Top 5 Biosimilar Articles for the Week of December 18

The Top 5 Biosimilar Articles for the Week of December 11

Number 5: Brian Biehn, senior director of biosimilar commercialization at Cencora, formerly known as AmerisourceBergen, recaps some of 

the major regulatory updates for biosimilars

 in the United States and makes predictions for how the market will develop in the years to come.

Number 4: After Humira’s patent expired in 2018 in the European Union (EU) and earlier this year in the US, 10 adalimumab 

 in the EU and 8 entered the market in the US. A 

 discussed the characteristics of the available biosimilars to help clinicians navigate the various options with their patients.

 and safety of GP2017 in patients with inflammatory bowel disease (IBD) who were naïve to adalimumab or switched from the originator (Humira) or another adalimumab biosimilar.

estimated the impact of biosimilar substitution

 on total cost of care (TCOC) and provider financial performance in the final performance period of the Oncology Care Model.

Number 1: A report from IQVIA noted that Europe could miss out on €15 billion in cost savings by not having 

 about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.

Here are the top 5 biosimilar articles for the week of December 11, 2023.

Brian Biehn from Cencora makes predictions for the US biosimilar market based on recent FDA approvals

Cencora's Brian Biehn Forecasts Big Changes for the US Biosimilar Space

Brian Biehn, senior director of biosimilar commercialization at Cencora, formerly known as AmerisourceBergen, recaps some of the major regulatory updates for biosimilars in the United States and makes predictions for how the market will develop in the years to come.

2023 was a big year for biosimilars in the US, with the market introductions of 8 adalimumab biosimilars as well as regulatory approvals for the first biosimilar tocilizumab, nataliuzmab, and subcutaneous infliximab. How do you think these advancements will shape the biosimilar market in the coming years?

Yeah, 2023 was definitely a big year for biosimilars. As you mentioned, we continue to have really good momentum with approvals. The approvals are written into new molecules such as tocilizumab and natalizumab. The approval for natalizumab [marks] the first neurological biosimilar, which is expected to hit the market in 2024. All eyes are still on adalimumab, though, and the Humira biosimilars.

So, today we have 9 manufacturers that have [approvals and 8 launches for] biosimilars to Humira [reference adalimumab]. There are still a few in the pipeline. We do believe the success of the future market is going to be shaped by the Humira market, specifically for the pharmacy benefit space [overall] and those biosimilars to come. So they're all kind of looking at Humira and seeing how are those manufacturers going to do? How successful are they going to be? What is the adoption going to look like?

To date, we've seen slow uptake of those Humira biosimilars, but we are expecting that to become more widespread going into 2024 and 2025. We believe there's kind of a period here where [pharmacy benefit managers] and payers need to become comfortable with the Humira products; they need to put them on the formulary. Also, from a downstream perspective, customers and patients need to become more comfortable with these products. So, even though it's been a slow start for Humira [biosimilars] and that's probably the biggest thing that happened in 2023 with those [launches], we do see some upside and are expecting more adoption to occur in the coming years.

Now that ophthalmology biosimilars have been on the market for a year and both FDA-approved products now have interchangeability, what is the current status of ophthalmology biosimilars and how to do you see this changing going forward?

Ophthalmology biosimilars are doing well. We've seen month over month the adoption continues to increase. We do anticipate that this trend is going to continue as there are still more manufacturers in the pipeline, specifically for the Lucentis [ranibizumab] biosimilars, which already have the 2 biosimilars on the market.

We're also really interested to see where the Eylea [aflibercept] market goes. We're expecting, potentially in 2024, biosimilars will start to move in that market. We have some ongoing patent litigation occurring right now that could push that launch back to later, but the most optimistic right now is potentially 2024.

One of the things that we continue to talk about with ophthalmology biosimilars—we've talked about in the past and it's important to most of the biosimilar market categories, but more specifically this one—is education. We've heard that there has been confusion amongst providers and patients with these products, not being aware that they're available, being a little bit hesitant to use them because it is an injection into the eye. So, education still remains to be the largest barrier. We have seen that education gap tighten. As I've said, the adoption has increased over time, but I still think it's important for us as an industry to keep pushing that education forward and trying to combat any misinformation that's going on and drive awareness of these products.

Brian Biehn, senior director of biosimilar commercialization at Cencora, makes predictions for how big regulatory approvals in 2023 will shape the biosimilar space going forward.

Here are the top 5 biosimilar articles for the week of December 4, 2023. 

The Top 5 Biosimilar Articles for the week of December 4, 2023

 noted that Europe could miss out on €15 billion in cost savings by not having biosimilars for medications about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.

 where data were collected from patients with inflammatory bowel disease (IBD) showed safety and efficacy of the adalimumab biosimilar HS016.

Number 3: Several companies make moves to further their 

, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab). 

Number 2: Sarfaraz K. Niazi, PhD, offers hope for the end of 

 in the United States in his latest column.

Number 1: With numerous adalimumab biosimilars launched in the United States in 2023, the impact of an 

 has been extensively discussed with much speculation, but its commercial significance is yet to be determined.

The Top 5 Biosimilar Articles for the Week of December 4

Here are the top 5 biosimilar articles for the week of November 27, 2023. 

The Top 5 Biosimilar Articles for the Week of November 27

Number 5: Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for 

 in spending remain, according to a report from the HHS.

 their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).

Number 3: Biosimilar experts highlight the persisting confusion around 

 for biosimilars, including misunderstandings about the definition of interchangeability and the purpose these labels serve.

Number 2: As new biosimilars are added to CVS Caremark’s standard formulary, 

. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.

Number 1: Sarfaraz K. Niazi, PhD, offers hope for the end of interchangeability labels in the United States in his 

Chelsee Jensen, PharmD, explains adalimumab pricing strategies

Dr Chelsee Jensen Discusses Pricing Strategies for Adalimumab Biosimilars

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the interchangeability approval for Abrilada and attempts to explain the purpose of dual-pricing strategies for adalimumab biosimilars.

Several adalimumab products that entered the US market this year launched with 

. Can you explain why a company would use this pricing strategy and do you think this trend will continue in other markets?

I do think with the pharmacy benefit drugs, we might continue to see this trend. And this is happening because, again, from a manufacturer standpoint, in order to get on to some of these insurance formularies, we realize that some insurance companies have a historical precedence of being used to these large back end rebates. So that's, we'll see manufacturers potentially come into the market with 2 list prices to be more appealing to those insurer markets, whether they want the lower discount or the more deeper discount. 

But one thing that we'll have to kind of keep trending and watching out for in this space, especially with adalimumab, is what's happening to the patient. I know a lot of talk or assumption is that the patient will utilize manufacturer co-pay assistance. However, we have to recognize that not every single patient on an insurance plan is going to qualify for that. So are we truly opening up access? And I think that'll just be something to continue to watch as adalimumab biosimilars rollout.

Recently, Abrilada was approved as the second interchangeable adalimumab biosimilar. How do you think the interchangeability label will influence payer preferences and prescription habits in the adalimumab space?

I do think that interchangeable ability makes it much easier. Obviously, you do not need to intervene and contact the provider to change the prescription over. However, I think that smaller community sites could come up with alternative mechanisms such as potentially collaborative practice agreements if their state state laws allow that and that would still kind of get over that operational hurdle of that interchangeability. 

But again, I don't know that they don't necessarily have a huge impact on insurers uptaking biosimilars. I think they're probably going to be focused more on does the delivery of device match what that reference product is and what are those price points.

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, explains the purpose of dual-pricing strategies for adalimumab biosimilars and predicts whether these strategies will occur in other treatment spaces.

Here are the top 5 biosimilar articles for the week of November 20, 2023. 

The Top 5 Biosimilar Articles for the Week of November 20

biosimilars of tumor necrosis factor (TNF)

 inhibitors within Poland’s public payer saved over €243 million from 2013 to 2021, with about 68% of that coming from the rheumatic musculoskeletal diseases alone. 

Number 4: In part 2 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars

 evaluating the use of subcutaneous trastuzumab biosimilars to treat breast cancer in a French hospital setting.

Number 3: At the recent Academy of Managed Care Pharmacy Nexus meeting, panelists discussed the impact of introducing biosimilars in new medical fields, emphasizing 

the need for more education and collaboration

 to ensure their smooth integration into health care systems.

Number 2: In part 1 of a 3-part series for 

 The Center for Biosimilars looks at a retrospective study comparing the clinical benefits, price changes, and uptake associated with oncology biosimilars in China.

Number 1: In part 3 of a 3-part series for Global Biosimilars Week The Center for Biosimilars reviews an analysis investigating whether 

 have an impact on prescribing decisions for oncology biosimilars across Europe.

To read all of these articles and more, visit centerforbiosimilars.com. 

Evolution of Auto-Substitution in Biosimilar Landscape 

This is a video synopsis/summary of a panel discussion involving distinguished experts in the medical field: Ryan Haumschild, PharmD, MS, MBA; Alice B. Gottlieb, MD, PhD; Bincy Abraham, MD, MS; Jamie T. Brogan, APRN; and Vibeke Strand, MD. The focus of this segment is on interchangeability studies and automatic substitution.

Haumschild initiates the discussion by emphasizing the importance of understanding interchangeability studies in the context of biosimilars. Haumschild delves into the evolving landscape of biosimilars, stressing the need for robust clinical data to establish interchangeability.

Brogan provides a practical perspective on automatic substitution. She discusses the challenges faced by health care providers, emphasizing the potential impact on patient care. She underscores the importance of transparent communication in navigating the complexities associated with automatic substitution.

Gottlieb contributes insights into the intricacies of interchangeability studies. She highlights the challenges associated with extrapolating data and underscores the need for comprehensive studies to ensure the safety and efficacy of biosimilars.

Video synopsis is AI-generated and reviewed by editorial staff.

Professionals speak to auto-substitution and its Impact on the shared decision-making process associated with biosimilars.

Defining Interchangeability and Switching in Biologics

This is a video synopsis/summary of a panel discussion involving esteemed experts Ryan Haumschild, PharmD, MS, MBA; Alice B. Gottlieb, MD, PhD; Bincy Abraham, MD, MS; and Vibeke Strand, MD. The focus of this segment is on the crucial topic of interchangeability in biosimilars, shedding light on the FDA’s criteria and the implications for clinicians.

Strand introduces the concept of interchangeability, emphasizing its importance as a designation. Currently, only 1 biosimilar, adalimumab-adbm (Cyltezo), has received this designation, signifying that it has undergone switching studies in which patients alternated between the biosimilar and the reference product without compromising efficacy or safety. This is particularly significant for immunogenicity, a crucial consideration with biologics like adalimumab (Humira). Strand underscores the reassurance provided by interchangeability, preventing disruptions in treatment that could lead to complications.

Brogan delves deeper into the requirements for interchangeability from the FDA. To achieve this designation, a biosimilar must prove that it can be switched multiple times between the reference product and the biosimilar without increased risks such as loss of response, safety events, or immunogenicity. This necessitates rigorous switching studies, exemplified by trials like NOR-SWITCH (NCT02148640) and the VOLTAIRE studies, demonstrating the safety and efficacy of multiple switches.

Medical experts discuss interchangeability designation requirements for biosimilars.

Here are the top 5 biosimilar articles for the week of November 13, 2023.

The Top 5 Biosimilar Articles for the Week of November 13

Hi, I’m Skylar Jeremias for The Center for Biosimilars

, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars looks at a retrospective study comparing the clinical benefits, price changes, and uptake associated with oncology biosimilars in China.

Number 4: At the recent Academy of Managed Care Pharmacy Nexus meeting, 

 the impact of introducing biosimilars in new medical fields, emphasizing the need for more education and collaboration to ensure their smooth integration into health care systems.

Number 3: A real-world analysis from Japan confirmed that CT-P13, an 

, had comparable safety and efficacy to the reference product (Remicade; infliximab) in patients with immune-mediated inflammatory diseases.

Number 2: The use of biosimilars of tumor necrosis factor (TNF) inhibitors within Poland’s public payer saved 

 from 2013 to 2021, with about 68% of that coming from the rheumatic musculoskeletal diseases alone.

 for its denosumab biosimilar candidate; the Community Oncology Alliance (COA) forms the Drug Policy and Regulation Committee; the International Generic and Biosimilar Association (IGBA) and the World Health Organization (WHO) collaborate on a new initiative.