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 November 21, 2022.

Number 5: As the US awaits the 2023 launch of adalimumab biosimilars, Biogen 

 against Sandoz over a natalizumab biosimilar, Rani Therapeutics initiated a development program for an oral ustekinumab biosimilar, and Bio-Thera Solutions bagin a phase 3 trial for a secukinumab biosimilar.

Number 4: In Biocon’s second quarter of fiscal year 2023 earnings report, 

 23% year over year (YoY) for the company, largely in thanks to the 34% increase in revenues for biosimilars, which accounted for 42% of the total company revenue.

Number 3: Organon Canada launched 2 biosimilars referencing Avastin (bevacizumab) and Herceptin (trastuzumab), China became the first country to approve a denosumab biosimilar, and Optum Rx, a large pharmacy benefit manager (PBM), said that it will 

Number 2: A review explored the 3 main administration options for pegfilgrastim biosimilars, finding that 

 the ease and frequency to which patients will need to travel to a clinic for administration as well as their preferences when choosing a mode of administration.

 for Ximluci, the third ranibizumab biosimilar to be approved in the European Union. The product was developed through a partnership between STADA Arzneimittel and Xbrane Biopharma and is expected to launch in early 2023.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of November 21

Technology utilizing electronic medical records pathways can be useful for practices struggling to manage multiple biosimilars for the same reference product, according to Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute.

How can technology be used to allow for better biosimilar adoption and adequate oversight, especially in practices that have to carry multiple biosimilars for the same originator?

Yeah, so, technology is always going to be something that's going to help drive the stewardship of biosimilar utilization and biosimilar use as a whole. And I think as we see more agents getting approved, it's very exciting. But once you have your seventh or your eighth biosimilar for a specific indication, how do you control which one you need to order, what are  going to be your levels, and what centers are you going to carry them at?

And so, as we design electronic medical record order sets and pathways, we start to specify preferred products. We meet with our payer colleagues to make sure that aligns with their payer approved processes, but at the same time, we start to prefer individual agents. This allows us to streamline the inventory we have on hand, help drive the prescriber to the most appropriate biosimilar use, and lastly, preserve our days cash-on-hand through the use of cash and cash equivalents within our inventory.

Dr Ryan Haumschild Explains How Technology Can Help Practices Juggle Multiple Biosimilars

Here are the top 5 biosimilar articles for the week of November 14, 2022.

Number 5: The efficacy and safety of bevacizumab biosimilars in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (CRC) is comparable with the reference product (Avastin) and each other, according to 

 at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting explored the adoption of infliximab biosimilars, utilization patterns of bevacizumab biosimilars in ophthalmology and oncology settings, and the budget impact of transferring patients to a natalizumab biosimilar from the originator.

Number 2: As the US awaits the 2023 launch of adalimumab biosimilars, Biogen announced an 

 Sandoz over a natalizumab biosimilar, Rani Therapeutics initiated a development program for an oral ustekinumab biosimilar, and Bio-Thera Solutions began a phase 3 trial for a secukinumab biosimilar.

Number 1: If every adalimumab biosimilar had an interchangeability designation, the United States could save an additional 

, according to calculations from 3 biosimilar experts.

The Top 5 Biosimilar Articles for the Week of November 14

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, describes how local health policy initiatives can help providers and patients feel more comfortable with the idea of interchangeable biosimilars.

What policy initiatives can be adopted to ensure that concerns regarding interchangeability are mitigated and that patients are confident in the efficacy of all biosimilars?

So, I think there's policies both nationally [and] locally in our own health systems where we can drive forward the most change. And I think we need to learn from our European colleagues: How do we leverage real-world evidence so people can understand the benefits of it?

I think when we look at policies too, we recognize that with interchangeability by the FDA, not every [company is] going for it, and we recognize that it takes extra money to get an FDA approval with interchangeability.

So, how do we leverage some of our pharmacy and therapeutics policies to determine that if biosimilars are approved, we consider them equally efficacious? And that allows us to go ahead and interchange products upon dispensation with approval of the medical executive board. I think that really creates change much faster. We don't have to wait on certain therapies being interchangeable or not interchangeable, and at the end of the day, it allows us to drive consistent care.

And lastly, how do we leverage data from curative intent patient populations to noncurative intent patient populations and across different disease states, both oncology and nononcology?

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, describes how local health policy initiatives can help providers and patients feel more comfortable with the idea of interchangeable biosimilars. 

Dr Ryan Haumschild Speaks on How Local, National Policy Can Increase Confidence in Interchangeability

When first-generation biosimilars were introduced in the United States, there was much anticipation about their potential to reduce the rising cost of medicines. Currently there are more than 35 biosimilars approved by the FDA, and more than 20 of which are available to patients. However, their adoption has been stymied by several factors, including perceptions of inferiority among health care providers and patients and the intricacies of market access in the US health care system.

This year has been a "turning point" for US ophthalmic biosimilars, with entry of the first biosimilar. What headway are biosimilars making in competing with other anti–vascular endothelial growth factor drugs? How can regulators, academic societies, and industry play a greater role in improving the understanding of biosimilars in the retina community? Other than lack of education, what barriers exist to biosimilar adoption and how can they be addressed?

®'s The Center for Biosimilars® co-hosted a moderated digital open forum facilitating an interactive discussion among health care professionals, health system executives, health care payers, and health policy influencers about promise and the barriers to the expanded use of biosimilars in ophthalmic applications.



, director, Office of Therapeutic Biologics and Biosimilars/OND/CDER, FDA

, Alliance Committee Cochair, Biosimilars Forum

, interim chair, Department of Ophthalmology and Visual Sciences, University of Chicago Medicine

 senior vice president, Rebate, Trade Relations and Formulary Strategy, Magellan Health

, vice president, Head of US Market Access, Samsung Bioepis

To read the article summarizing some of the major topics of discussion, 

A moderated digital open forum facilitated an interactive discussion among health care professionals, health system executives, health care payers, and health policy influencers about promise and the barriers to the expanded use of biosimilars in ophthalmic applications.

In Sight: The Future of Biosimilars in Ophthalmology Care

What strategies can health care institutions like Emory Healthcare implement to improve biosimilar adoption rates?

There are so many strategies, and it really depends on what's going on with your individual institution. I think a few of them are doing a baseline survey. You need to recognize where your barriers are because there are so many, but every institution is different. And so do we recognize is it related to the electronic medical record? Is it related to provider understanding and uptake? What about your finance team? Do they recognize that lower expense might recognize lower revenue, but that might not necessarily be a bad thing all the time?

I think when you can work through those barriers and designate key stakeholders to make more expedited decisions, that allows for faster uptake. Also, if you can get a P&T [pharmacy and therapeutics] policy approved, where pharmacy might have the ability to interchange biosimilars based on payer or individual hospital preferences, it allows for more timely adjudication and delivery of care to the patient and doing it at a reduced cost. So, I think if you can work through those barriers, focus on the electronic medical record, your key stakeholders clinically and financially, and create some of these tools, that's going to create better uptake, faster uptake, and you're going to be more efficient with your care model.

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, offers advice to health systems on how they can incorporate some of Emory Healthcare's strategies to promote biosimilar uptake.

Dr Ryan Haumschild: What Health Systems Can Learn From Emory Healthcare's Biosimilar Strategy

Here are the top 5 biosimilar articles for the week of October 17, 2022.

Number 5: St John Skilton, PhD, vice president of product strategy and marketing at Protein Metrics, takes a deep dive into how the development of biosimilars is evolving and how tools, such as mass spectrometry, can 

Number 4: Bio-Thera Solutions began a phase 1 trial for its 

 candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

Number 3: Biosimilars Canada, a national association representing the Canadian biosimilar industry, held a press conference 

, the province containing the nation’s capital, to institute a biosimilars switching policy.

 explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.

Number 1: A study from the Republic of Korea confirmed the safety and efficacy of 

 in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.

The Top 5 Biosimilar Articles for the Week of October 17

This interview was filmed at The American Journal of Managed Care

Several companies are currently working on developing nivolumab and pembrolizumab biosimilars

. How do you expect these products to help in the fight to end OPSCC (oropharyngeal squamous cell carcinoma) if they get approved and enter the market?

Great question. Nivolumab [Opdivo] and pembrolizumab [Keytruda] are both FDA-approved now for treatment of advanced metastatic head and neck cancer, including HPV [human papillomavirus]–related head and neck cancer, [such as OPSCC]. And by the way, this continues to be a big challenge as far as treatment for metastatic disease and when we talk about the necessity for vaccination, we really have to look at the other end of the spectrum when patients come to our clinic with advanced metastatic head and neck cancer and have very few options to get to get therapy.

Thankfully, we're having some improvement in the availablility of treatments for these patients. So, to remind people nivolumab and pembrolizumab are both PD [programmed death]–1 inhibitors; therefore, they are immunotherapeutic drugs. They're not really killing cancer cells by poisoning these cancer cells like chemotherapy or radiation. They are really working with a person's own immune system to fight off these cancers, and HPV-related head and neck cancer does respond fairly well to these agents.

I think the question of biosimilars is a very interesting question overall. And I think that if these biosimilar agents become approved, I think that will open the door for treating more patients, because cost of these currently approved drugs is really prohibitive in many instances for getting them administered to every segment of the population. And I think because biosimilars reduce the cost, basically, they will allow us to focus on reducing the cost and getting the rest of the of the saved cost, essentially, into other functions or into other missions—perhaps treating more patients, perhaps prevention, perhaps vaccination.

When you reduce the cost of these drugs, there's a big advantage, I think, at the society level overall, because you're able to basically funnel the saved money essentially to fund other functions that are very important. So, I look forward to actually having these [biosimilar] drugs down the line and to be approved, and I think we are starting to see this in several segments of health care and oncology.

Nabil Saba, MD, a medical oncologist and immunotherapy specialist in the treatment of head and neck cancer at Emory Healthcare and the Winship Cancer Institute, explained how the eventual introduction of biosimilars for Opdivo (nivolumab) and Keytruda (pembrolizuamb) will help patients with head and neck cancer.

Dr Nabil Saba Shares His Hope for Future Opdivo, Keytruda Biosimilars

Here are the top 5 biosimilar articles for the week of October 3, 2022.

Number 5: Sarfaraz K. Niazi, PhD, explains the significance of the European Medicines Agency (EMA) declaring that 

 with their reference products and calls for the United States to do the same in the first installment of his new monthly column.

 of a 4-part series assesses what payers should know about the US introduction of adalimumab biosimilars coming in 2023 as well as policy considerations they can implement to reap the benefits of biosimilar savings.

 Lupin Limited’s Rymti, the third etanercept biosimilar to be granted regulatory approval in the country. Meanwhile, Prestige Biopharma announced that it withdrew its European application for its trastuzumab biosimilar.

 Celltrion Healthcare’s Vegzelma (bevacizumab-adcd; CT-P16), a biosimilar referencing Genentech’s Avastin. The approval marks the fourth bevacizumab biosmilar to be approved in the United States.

 of the Inflation Reduction Act—a 5-year temporary increase in the add-on payment for qualifying biosimilars to encourage their utilization—took affect October 3.

The Top 5 Biosimilar Articles for the Week of October 3

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.

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.