Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science, made predictions on what will drive biosimilar uptake and savings over  the next 5 years using the data from 

IQVIA's Biosimilars in the United States 2023-2027 report

 at Access!, the annual meeting of the Association for Accessible Medicines in Orlando, Florida.

The latest IQVIA Biosimilars in the United States report predicted that spending on biosimilars will increase to $129 billion and generate $180 billion in savings over the next 5 years. What are going to be some of the biggest drivers for these numbers going forward?

Obviously, the biggest drivers in the next few years are adalimumab biosimilars. But there's other products in the same category: ustekinumab (Stelara) biosimilars is coming very soon. There's also some other areas, like age-related macular degeneration. So, ranibizumab and following slight thereafter is aflibercept. 

But we have a an outlook with a number of these medicines that we think are going to have a reasonably big impact on the dollars going to the biosimilars, as well as to the savings. We also profile a significant set of uncertainties we feel like in terms of the uptake and the different behavior of individual companies in marketing the biosimilars. How competition has so far worked out in terms of the concentration in the market. 

Imagine a circumstance where there's a large number of companies challenging one particular molecule and not all of them make their return. The sustainability of the market for biosimilar makers is a key question, as well as the sustainability if biosimilars are not entering the market or are lower selling than originators. So, a lot of questions that really frame the future of this sector where there are 300 or so molecules that are biologics, and so far, we have 39 of them with approvals or are in the pipeline, and many more that have not yet begun that journey; it's unclear how many will.

The report focused a bit on the US market introduction of up to 10 adalimumab biosimilars, including Amjevita, which just launched at the end of January 2023. How do you anticipate this portion of the biosimilars market developing through 2027 and what are going to be the main factors driving utilization trends for these products?

The thing that we include in a couple of the exhibits in the report is is an assessment of the adalimumab market for a couple of key dynamics. 

One, you mentioned, is the number of challengers, but the other is the nature of the originator. Subsequent to the original launch of adalimumab, there have subsequently been reformulations, with a high-potency and citrate-free formulation and a significant migration of the current patients to this newer formulation. Not all of the biosimilars are formulated the same way. There is a difference in the administration a patient would experience and perhaps those benefits are valuable to patients and providers. 

So, there's definitely a question of essentially as an analog, when we think about what adalimumab is doing in terms of continuing to move that innovator forward, how that has played out in other molecules when we see that in filgrastim and pegfilgrastim. When we see that in the breast cancer market with trastuzumab and other related products from the originators [Herceptin]. The relevant market of the originator that the biosimilar is similar to may not be the same when we get our biosimilars to the market as it was when the development program started. 

Understanding how that market is going to evolve and whether the value of subsequent innovations is telling, or whether the cost savings is the telling feature, all of those are influenced by the negotiating power of the different participants. The more challengers there are, the more game theory comes into play and the more nuanced and generally the deeper the price erosion and volume erosion tends to be. 

Fewer competitors tends to result in lower price discounting as well. And those are patterns that we've seen go back to small molecules and back to the beginning of the H

 So, we should expect to see many those things come out. But it's going to be interesting to see what the participants do. 

Probably my key observation on this is the way in which the originators participate in these markets. We've seen a mix. Historically, we've seen originators essentially exit—not lower their price post expiry, not compete on price with the biosimilars essentially. We've also seen them lower their price and essentially compete for the volume and the contracts after the presence of biosimilars. 

Those will have an effect, and there is a scenario you can imagine where this system, society as a whole, saves money because of the presence of biosimilars but the biosimilar maker isn't rewarded for it commercially. That could be one of the outcomes we see here; it's a lot of money that we're talking about. These are big selling products sometimes. The amount to play for is certainly motivating and that's why you're seeing, as you said, as many as 10 competitors, and some of the other products have a similar number.

Videos

Adalimumab and ustekinumab biosimilars aren't the only factors that will drive biosimilar adoption and savings through 2023, according to Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.

What Will Be the Major Drivers Behind IQVIA's Predicted Biosimilars Uptake, Savings?

Hi, I’m Justina Petrullo 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 January 30th, 2023.

 the company’s biologics license application (BLA) for its denosumab biosimilar candidate for review.

Number 4: Sarfaraz K. Niazi, PhD, explained the 

 to the drug review process, the significance of each change, and the published pieces of work that helped inform the FDA's decisions.

 as part of the Biosimilars User Fee Act III regulatory research pilot program. The roadmap will allow stakeholders to see how the program will help the FDA enhance regulatory decision-making surrounding biosimilar development.

Number 2: This year started off with a bang for 

, with several regulatory approvals around the world, new market insight into the global use of biosimilars, and US market introduction of the first rival biosimilar to Humira (adalimumab).

Number 1: Amgen’s Amjevita (adalimumab-atto) has 

 the US market, making it the first of potentially 10 biosimilars referencing Humira to launch in 2023.

To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of February 6, 2023.

The Top 5 Biosimilar Articles for the Week of February 6

Hi, I’m Justina Petrullo for The Center for Biosimilars

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

 has revealed that if the Inflation Reduction Act (IRA) had been implemented in 2020, Medicare Part D beneficiaries could have saved a total of $734 million, averaging out to about $500 per member.

Number 4: As part of a series of interviews, Kyung-Ah Kim, executive vice president of Samsung Bioepis, 

 into how developers view the current biosimilars market, the relevance of interchangeability, and the usefulness of clinical efficacy testing.

Number 3: Sarfaraz K. Niazi, PhD, explained the 

Number 2: Saudi Arabia approved an adalimumab biosimilar, a denosumab biosimilar entered the market in the Republic of Korea, and Dr. Reddy’s Laboratories 

 of a phase 3 study for its rituximab biosimilar

Here are the top 5 biosimilar articles for the week of January 30, 2023.

The Top 5 Biosimilar Articles for the Week of January 30

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 January 23, 2023.

Number 5: IQVIA’s Global Use of Medicines Report for 2023 has revealed increased uptake of biosimilars around the world and predicted that biosimilars could generate 

, Kyung-Ah Kim, executive vice president of Samsung Bioepis, offered insight into how developers view the current biosimilars market, the relevance of interchangeability, and the usefulness of clinical efficacy testing.

Number 3: Patent litigators from Fish & Richardson, an intellectual property law firm, regaled audiences during a webinar covering all the big biosimilar regulatory and legal decisions throughout 2022, including 

Number 2: Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health in Sacramento, California, detailed the regulatory decisions from 2022, what's to come in 2023, and how the US biosimilars market is 

 for their respective license partnerships; Samsung Bioepis sped up interchangeability study for its adalimumab biosimilar; Dong-A ST shared positive phase 3 results for its ustekinumab biosimilar.

The Top 5 Biosimilar Articles for the Week of January 23

Here are the top 5 biosimilar articles for the week of January 16, 2023.

 STADA Arzneimittel and Xbrane Biopharma’s Ximluci, a ranibizumab biosimilar referencing Lucentis, for the treatment of retinal conditions.

Number 4: The China National Medical Products Administration (NMPA) approved Bio-Thera Solutions’ 

 (BAT1806) referencing Actemra for the treatment of several rheumatic conditions.

Number 3: Alvotech announced that a phase 1 pharmacokinetic study for its 

 for Celltrion Healthcare’s bevacizumab biosimilar (Vegzelma) referencing Avastin for the treatment of multiple forms of cancer.

 of biosimilars found that while the United States had significantly higher prices, the uptake in Germany and Switzerland, 2 European countries with national mechanisms for drug price negotiation, was slower.

The Top 5 Biosimilar Articles for the Week of January 16

Here are the top 5 biosimilar articles for the week of January 9, 2023.

Number 5: IQVIA’s eighth edition of its Impact of Biosimilar Competition in Europe report 

 in many countries throughout the region. However, not every country has great adoption rates and companies may have a harder time choosing which molecules to invest in for biosimilar development.

Number 4: Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, demonstrated why regulatory bodies in the United States 

 economic evaluations when reviewing regulatory data for biosimilars in his latest column.

Number 3: Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its 

 allowing for subcutaneous administration (Remsima SC).

Number 2: The authors of a retrospective real-world study of patients with hidradenitis suppurativa treated with adalimumab concluded that switching patients between adalimumab products risked a greater likelihood of

Number 1: Alvotech, an Iceland-based company, announced that the 

 its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.

The Top 5 Biosimilar Articles for the Week of January 9

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, gives his thoughts on the necessity of clinical efficacy testing for biosimilar approvals, switching studies to establish interchangeability, and the promotion of biosimilars within company environmental and social impact reports.

Lately, there have been a number of efforts to try to remove clinical efficacy testing for biosimilars and to remove switching study requirements for establishing interchangeability. What is Biogen’s view on these efforts and do you think removing these requirements would create more confusion about biosimilar safety?

The intent of these discussions is to maybe open up the market. Some may see it as to lower the threshold. But we should recall that the body of evidence to get a regulatory approval is generally only the preclinical aspect. So, it's about the technical process, the manufacturing, etc. If we divide the clinical studies into 2, phase 1 and/or phase 3, you need to probably keep phase 1 for the right reasons, except in certain circumstances where you don't want to be putting an active drug into, say, an eyeball. 

If you did, under the scenario that you did eliminate a phase 3 study, because the body of the totality of evidence found—for example, in Europe, is 1 million patient-years of data—you would then say, "Does that prove anything? Is it necessary in terms of confirming comparability between the innovator and the biosimilar?" In that circumstance, you wouldn't do switching studies, and therefore, you wouldn't have an interchangeability discussion. 

But I think the discussion is, if the body of evidence is within the early preclinical stage, which is about comparability within certain tolerances and also includes a phase 1, you've probably covered most of the question marks around switching from one biologic to another biologic to another biologic, which, by the way, is what happens when you go from one innovative batch to another innovative batch to another innovative batch. They're all similar to the first reference batch, and I think that is where the body of evidence and real-world data starts to come to play and actually opens up the possibilities of this marketplace.

Earlier this year, The Center for Biosimilars

 wrote a piece on how companies are using their biosimilar development portfolios as part of their environmental and sustainability reports and social impact reports. Why is it important for companies to establish how their biosimilar portfolios impact the world?

So, commitment to ESG [environmental, social, and corporate governance] is a long-term journey for everybody. That's number 1. I think number 2 is, we have been reporting on that at Biogen for some time. And number 3, when we look to the future and what we can do, most importantly, what our customers are now asking us to provide evidence on, they're asking us to provide evidence of our ESG credentials within some of the contract structure of tenders and contracts. And I think that's good. That's a step forward. Again, that will move forward as we start to think about some of our COP [United Nations Climate Change Conference] commitments across the across the world.

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, shares his thoughts on whether clinical efficacy and switching studies to establish biosimilar safety are necessary, a hotly debated topic in the biosimilars industry.

Biogen's Ian Henshaw Weighs in on Clinical Efficacy, Switching Studies for Biosimilars

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 December 19, 2022.

 Biogen’s biologics license application for a biosimilar candidate (BIIB800) referencing Actemra (tocilizumab) for review. If approved, the drug will be used to treat several conditions, including rheumatoid arthritis, idiopathic polyarthritis, idiopathic arthritis, and sclerosis-associated interstitial lung disease.

Number 4: A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the 

 RD12014 and the reference product (Victoza) in healthy male participants.

Number 3: Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and 

 in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.

Number 2: Johnson & Johnson’s Janssen unit 

 against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.

 of its adalimumab biosimilar Idacio (adalimumab-aacf), making it the eighth biosimilar referencing Humira (adalimumab) to be approved in the United States.

The Top 5 Biosimilar Articles for the Week of December 19

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, recapped the launch of Biogen's and Samsung Bioepis's ranibizumab biosimilar as well as how leveraging campaigns like the International Generic and Biosimilar Medicines Association's Global Biosimilars Week can help boost biosimilar adoption rates.

Biogen and Samsung Bioepis had a big year with the launch of Byooviz, the first ophthalmology biosimilar and the first ranibizumab biosimilar to enter the US market. What has been your initial experience with this launch and how do you expect this market will play out in 2023?

So, from the voice of the customer, we've heard excitement about Byooviz approval and launch into the marketplace. The ophthalmology market in this area, [Medicare] Part B in the US, is probably characterized by a lot of private equity groups that run ophthalmology clinics. Plus, there's a group of new operators that are operating in retinal specialist centers with maybe 1 or 2 physicians. And so you get 2 different aspects of the business. 

From that perspective, it's been well received. In terms of insurance coverage, again, insurance coverage is being positive in terms of speed to getting that coverage applied. And then, I think in terms of the programs that we've got in place, like patient services, etc, it's been an overall positive response.

Why are companies like Biogen so focused on investing in biosimilar development, especially in newer markets, such as ophthalmology and rheumatology?

Firstly, when people look at biosimilars from a company perspective, they're looking at it from an opportunity for revenue or to facilitate efficiencies around production or to deploy their technical knowhow, particularly in biotech. So, what you get is a number of different synergies. But on top of that, if you think about how we are relieving costs out of [Medicare] Part D or Part B, and then you're also putting new products into these areas, it has a very sort of balanced response with payers and providers of care in these areas. So, that's number one. What you're providing is savings and an opportunity for those savings to be used, either in new innovations or improving patient access. 

What we've seen, specifically on patient access and with reference to our business in Europe, we see a range of up to doubling of access, but generally, the overall access is about 2 times over the period. And then another aspect that we believe we've seen in some cases and in some countries is an overall improvement in patient pathway care. 

So, if you look at it through those 2 points, you actually get a much more holistic response. [With our] investment in that, the balance in terms of the pipeline, our mission in neurology, and also our mission to try and transform more lives, we get a good response.

Recently, Global Biosimilars Week passed, for which The Center for Biosimilars was a media partner. What is the importance of having this annual campaign and how can it be leveraged to improve global perception and adoption of biosimilars?

So, I think the singular fact that I found most interesting about Global Biosimilars Week was that there are over 600 biosimilars approved around the world. And that was a global context. If you boil that down to what's happening in the US, or you boil it down to what's happening in Europe, you get various stages of that journey.

Of the 89 approvals in Europe, it's covered 92 molecules. Now, the news is there are more than 100 different biologics being used in the marketplace to date. So, there is scope for more expansion. That's good. It's good for patients. It's good for potential savings on overburdened health care systems, whether it's pandemic- or age-related or just new areas that they want to invest in or treat. And you get this sort of dynamic, which I think we've only just started to appreciate, of the potential or the ability for biosimilars to unlock the potential in health care, as well as provide bigger access to patients around the world.

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, describes the importance of awareness campaigns like the International Generic and Biosimilar Medicines Association's Global Biosimilars Week and how these initiatives can be leveraged to improve biosimilar adoption and acceptance.

Biogen's Ian Henshaw: Why Global Biosimilars Week Is Important for Improving Adoption

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

, Sarfaraz K. Niazi, PhD, looked into the domestic and international support for removing interchangeability for biosimilars in the United States.

Number 4: The Accreditation Council for Medical Affairs (ACMA) is launching a 

 for health care professionals to become Board Certified Biologics and Biosimilars Specialists.

 Magellan Rx Management, a popular pharmacy benefit manager (PBM) in the specialty pharmacy space.

Number 2: The FDA has accepted Biogen’s biologics license application for a 

 candidate (BIIB800) referencing Actemra for review.

Number 1: Following their initial European launch of the drug, Alvotech and STADA Arzneimittel launched their adalimumab biosimilar referencing Humira in 

: Belgium, Bulgaria, Croatia, the Czech Republic, Latvia, Romania, and Slovenia.