How has the economic value of oncology biosimilars changed over time and how do the economic benefits differ between stakeholders?

I think the economic values continue to grow. We've seen from our European colleagues that they've been able to uptake these medications sooner and really reduce cost. And I think that's what a lot of us are interested in—how do we preserve efficacy and reduce cost? So, I think the economic benefits can continue to grow.

But it is different depending on the different stakeholder. So, from our payer colleagues, they are looking at rebating and getting the total cost of care down on their end by larger rebates and preferencing therapy. Whereas, on the hospital side, we're also looking at uptake of biosimilars to reduce the cost of care and still provide efficacious options. I think it's going to be interesting, though, in the future as more agents come forward, and the rebating continues, and how does that degrade the average sales price for the health systems, where it still provides economic value, and it'll be more interesting of how it impacts reimbursement moving forward.

What utilization trends have you observed and what are your predictions for how the oncology biosimilar space will evolve going forward?

Utilization is continuing to grow. I think that's something that we're excited about. And as we see more therapies come into the market, I think people are starting to recognize that having an adoption strategy is important. I think with that adoption strategy, people are becoming smarter in the way that they're building out their electronic medical records, deciding to designate policies in order to provide a better uptake and faster uptake. And I think at the same time, as payer colleagues are to preference biosimilars, we see it to grow. So, that being said, I know we have a lot of market approvals coming up in the next few years. I personally am really excited, and I think this will, in turn, create larger utilization and cost savings across the country and actually reduce the amount of spend in the US directly related to biosimilars.

Videos

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, explains how stakeholders may view the economic value of biosimilars differently based on their goals and his predictions for how biosimilar utilization will develop in the future.

Dr Ryan Haumschild Compares Viewpoints on Biosimilar Value Between Stakeholders

Coherus Rep Predicts How the Ophthalmology Biosimilars Space Will Develop

Coherus Rep Explains What Interchangeability Means in Ophthalmology vs Rheumatology

Coherus Rep Discusses Why Coherus Sought Interchangeability for Cimerli

Coherus Rep Previews the US Market Introduction of Adalimumab Biosimilars

Coherus Rep Shares Competition Strategy for Adalimumab, Pegfilgrastim Biosimilars

Part 5 available now! 

Paul Reider, MBA, chief commercial officer at Coherus Biosciences, chronicles why Coherus got an interchangeable designation for its ophthalmology biosimilar, how it plans to set its adalimumab biosimilar apart from the rest, and when the pegfilgrastim market could see a competitor for Neulasta Onpro.

Coherus Rep Discusses Interchangeable Ophthalmology Biosimilar, Previews Onpro Competitor

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.

Here are the top 5 biosimilar articles for the week of September 19, 2022.

 of its pegfilgrastim biosimilar referencing Neulasta, making it the sixth pegfilgrastim biosimilar to be approved in the United States.

Number 4: The third installment of a 4-part series dives into how providers, administrators, nurses, and pharmacists can 

 and what role they can play in patient acceptance and use of biosimilars.

 to its collection, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for another ranibizumab candidate.

 of a 4-part series took a look at what patients and employers can expect when adalimumab biosimilars hit the market in 2023.

Number 1: As more biosimilars are granted interchangeability status, 2 representatives from Samsung Bioepis 

 in its tracks by clarifying that the designation will primarily impact pharmacy dispensing instead of prescription habits.

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of September 19

Here are the top 5 biosimilar articles for the week of September 12, 2022.

Number 5: As Alvotech’s biosimilars are included in a commercialization deal in the Philippines, the company 

 in its quest for FDA approval of its adalimumab biosimilar; the FDA gives EpiVax a $2 million grant to run immunogenicity testing for biosimilars.

 of this 4-part series took a look at what patients and employers can expect when adalimumab biosimilars hit the market in 2023.

Number 3: As part of a larger series preparing for the US market entrance of adalimumab biosimilars in 2023, Steven Lucio, PharmD, BCPS, senior principal of pharmacy solutions at Vizient, makes predictions for how the rollout of these biosimilars may play out and offers advice to stakeholders for how to 

 for an ustekinumab biosimilar, and Samsung Bioepis announced long-term safety and efficacy results for its adalimumab biosimilar.

Number 1: In a recent paper, Sarfaraz K. Niazi, PhD, argued that getting rid of clinical efficacy testing for biosimilars could 

 with current guidelines, save companies money on development, and improve data sensitivity.

The Top 5 Biosimilar Articles for the Week of September 12

Here are the top 5 biosimilar articles for the week of August 8, 2022.

Number 5: While efforts to cap monthly insulin costs for Medicare patients at $35 survived a budget reconciliation bill in the Senate, Republicans 

Number 4: Coherus Biosciences’ ranibizumab product became the 

first interchangeable ophthalmology biosimilar

Number 3: Vizient’s Pharmacy Market Outlook report offered predictions on how the emergence of adalimumab biosimilars in 2023 will affect the biosimilar industry and what 

 in advance to ensure biosimilar adoption.

Number 2: In an interview with The Center for Biosimilars®, Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, broke down the 

, how they differ from biosimilars, and how they could alter the future landscape of the biologics industry.

 the biologics license application (BLA) for Fresenius Kabi’s biosimilar candidate for tocilizumab (Actemra).

The Top 5 Biosimilar Articles for the Week of August 8

Here are the top 5 biosimilar articles for the week of August 1, 2022.

 suggested similar efficacy and safety of a denosumab biosimilar candidate Arylia (AryoGen Pharmed) to the reference product (Prolia) in postmenopausal osteoporosis.

 were up by 23% from last year, thanks to the success the company has had with biosimilars, of which revenues increased by 29%, and generic drugs, which had an increased revenue of 19%.

Number 3: Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were 

 by the FDA and the European Medicines Agency.

Number 2: Prestige Biopharma and Intas Pharmaceuticals 

 to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals makes a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.

Number 1: Generic drug manufacturer Teva Pharmaceuticals would pay 

 more than 2500 lawsuits with states, local governments, and tribes over its role in the opioid epidemic under a settlement announced late Tuesday.

The Top 5 Biosimilar Articles for the Week of August 1

Hi, I’m Hayden Klein for The Center for Biosimilars

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

Here are the top 5 biosimilar articles for the week of July 25, 2022.

Number 5: The first 2 years of a Providence St. Joseph Health program to increase biosimilar uptake and cut costs created 

 and “biosimilar adoption rates that greatly exceed the US national average.”

 it will launch a pharmacokinetic (PK) study of AVT03, a proposed biosimilar for 2 different formulations of denosumab, which is used to treat serious bone conditions.

Number 3: Prestige Biopharma and Intas Pharmaceuticals 

 to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals made a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.

Number 2: Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were 

Number 1: In recent weeks, Celltrion Healthcare 

 (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.

The Top 5 Biosimilar Articles for the Week of July 25

Hi, I’m Hayden Klein for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of July 18, 2022.

Number 5: Abstracts from the European Hematology Association Congress 2022 confirmed 

comparable safety and effectiveness profiles

 between 2 rituximab biosimilars and the reference product (Rituxan) in patients with large B-cell lymphoma.

Number 4: Two experts in biosimilar intellectual property (IP) law broke down the 

issues that digital health and precision medicine face

 with IP and the history of case law that has created the current landscape.

Number 3: The 2022 “Trends in Biosimilars Report Preview” said 

 from the use of biosimilars climbed to $3 billion in the second quarter of 2022, for a total of $18 billion over the past 6 years.

Number 2: A real-world study on Pfizer and Celltrion Healthcare’s infliximab biosimilar (infliximab-dyyb, Inflectra; CT-P13) demonstrated 

positive clinical and patient-reported outcomes

 in patients with inflammatory bowel disease in the United States and Canada.

Number 1: Posters from the American Society of Clinical Oncology’s annual meeting showed the 

 of a trastuzumab biosimilar and a denosumab biosimilar in different types of cancer.

The Top 5 Biosimilar Articles for the Week of July 18

Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.

What should the FDA be doing to address the current backlog of inspections for biosimilar manufacturing facilities?

So, as we finished negotiations for the user fee, after that, we found out that biosimilar inspections were quite delayed. And unfortunately, if there's a delay in an inspection, there's a delay in approval of a biosimilar. And the biosimilar program inspections were the lowest—a little bit over 60%. So, we have multiple probe biosimilar applications that are not approved because the FDA did not do the inspection. Now, [we] completely understand about COVID-19, everything else, but what we're doing is advocating for the FDA—as part of user fees—we're advocating for the FDA to address this in a couple of ways.

One, FDA has a plan to do remote inspections. We're asking them to be sure that biosimilars inspections are always treated equitably, that we're not put on the bottom of the list and we're not deprioritized, and to use the process and procedures for remote inspections. The COVID-19 pandemic was tough, but we do believe that this won't be our first, unfortunately.

The other piece about the inspections, as we have heard from the FDA in our meetings, is that they plan to get all of the inspection backlog completed by the end of this year for fiscal year. So, we are cheering them on and also going to hold them accountable to do that, and especially with biosimilars because they're so important for patients and like we said cost savings. But yes, that's a key piece for us, to get those inspection backlogs up to date and completed for biosimilars.

Julie Reed On How the Biosimilars Forum is Helping FDA Catch Up on Biosimilar Inspections

Here are the top 5 biosimilar articles for the week of July 11, 2022.

Number 5: Some of the problems with use of 

 resemble those seen with all biologic drugs, while the authors say others are unique to the complexity of cardiovascular disease.

Number 4: A survey study found that many patients with breast cancer reported receiving 

 regarding switching from Herceptin to a trastuzumab biosimilar, with some patients reporting that they were never told a switch occurred or what a biosimilar was.

Number 3: During its annual conference in Sitges, Spain, Medicines for Europe recommended 

 for strengthening European health systems, including the use of off-patent medications like biosimilar and generic drugs.

Number 2: Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explains the difference between biosimilar 

 and weighs in on whether switching studies are necessary.

Number 1: As Alvotech announced that dosing of patients with its aflibercept biosimilar candidate has begun, Viatris announces its 

 for a batch of its insulin glargine biosimilar over missing labels.