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 March 20th, 2023.

Number 5: At the American Academy of Dermatology annual meeting, Samsung Bioepis shared 

 comparing its ustekinumab biosimilars (SB17) with the reference product (Stealara).

Number 4: In an article published in Frontiers in Pharmacology, 

 to improve the biosimilar regulatory system and refine biosimilar guidelines in China.

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

Indian manufacturers aren’t bringing biosimilars to the United States

 and how FDA policies and procedures discourage global companies from pursuing US market entry.

Number 2: The FDA's new artificial intelligence (AI)-based modeling on characterizing protein aggregation 

 the safety assurance of biosimilars and other therapeutic proteins.

interchangeability will not be a primary factor

 in driving the adoption of adalimumab biosimilars referencing Humira, contradicting predictions from other sources that believed the designation would impact prescribing habits

To read all of these articles and more, visit 

Videos

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

The Top 5 Biosimilar Articles for the Week of March 20

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

Number 5: In part 2 of this 2-part series, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, 

 guidelines from the World Health Organization (WHO) and how they view interchangeability and animal study requirements.

 a single-dose, prefilled autojector version of its pegfilgrastim biosimilar (Udenyca; pegfilgrastim-cbqv), for the treatment and prevention of febrile neutropenia, a common complication related to chemotherapy treatment.

 in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.

Number 1: The FDA and the European Medicines Agency (EMA) 

 for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

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

The Top 5 Biosimilar Articles for the Week of March 13

Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science, explained some of the biosimilar manufacturing and business trends found in 

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

 and his thoughts on legislative acts and their impact on biosimilar trends at Access!, the annual meeting of the Association for Accessible Medicines in Orlando, Florida.

IQVIA reported that more small drug companies are breaking out into the biosimilars space, with 79% of the biosimilar molecules under development being created by smaller manufacturers. Why are we seeing this trend growing and why are smaller companies more willing than before to invest in biosimilars?

We can only guess as to the motivations of the companies, but there are a number of signals here. One is certainly that the revenue available is attractive and the clarity in regulatory requirements and the ability to generate the biosimilar is something that more and more companies are able to do. It's also clear that there are some companies that may be perceived to be smaller, but they have specific expertise. There are a number of Korean companies that we might call essentially a service provider or they're developing biosimilars and then licensing them to larger companies at a later date. 

So, certainly one of our observations is that our percentage is maybe an artifact of they haven't been sold yet. But there's definitely an attractiveness to the large market potential and even a small share. If you're one of many competitors in a molecule with $20 billion of sales, even a small share of that at discounted rates would be a significant windfall for a smaller company and worth chasing.

The report noted that biosimilars tend to be more successful in plans with buy-and-build policies rather than white bagging policies. Why is this and what are the pros and cons of each framework?

The context here is important because, essentially, buy and build drugs are those which are administered by a doctor and they're reimbursed for them, whereas white bagging can often be the same drugs—So, it's not necessarily a different type of drug—but it may be that the reimbursement is less certain. 

In some cases, the provider is encouraging the patient to acquire the drug through their pharmacy benefit and will administer it, but they don't want the risk. In other cases, the plan may prefer that way of distribution to ensure the control of the appropriate formulary position and prior authorizations and so on. The degree to which your patients are exposed to cost, maybe in a high-deductible plan or maybe because of tighter control, is a limiting factor, which is limiting the white bagging. 

And essentially, it's if [the patient] has to pay for it. If I were a patient and if I have to pay for it or if I had to jump through some hoops in order to have that reimbursed, that's different in many cases than a medical benefit drug where the provider is very likely to get reimbursed. And I think that's really the issue. It acts as a proxy for the degree of control that's exerted by different stakeholders on the decision.

In addition to the Inflation Reduction Act (IRA), what other pieces of legislation should biosimilar companies be keeping an eye on when evaluating which biosimilars to invest in and develop next?

The pipeline for biosimilars is really informed by some medicines that are already available and certainly the next 10 or 15 years of biosimilars are really filled with some quite exciting medicines. 

The interesting challenges you mentioned in the IRA are whether that compound or whether that medicine will have had its price negotiated under the price negotiation provisions before the biosimilars arrive. That would change the available market size. It would change some go-or-no-go decisions, and that's still significantly uncertain. But beyond that, regulatory oversight of the requirements to develop and get a biosimilar approved and particularly interchangeability aren't really part of any of that legislation. They're part of what I would call a natural evolution of regulatory governance. 

Over time, our comfort societally and regulatory wise with biosimilars is growing. And so, at some point, the costs to be a developer and to achieve interchangeability may evolve. They may be lower. That would change the threshold, essentially, the commercial floor for whether a biosimilar is viable, and those are complex decisions. 

Essentially, you're talking about how much does it cost to run the trials? How much share are you likely to get? So, if some controls and a study could be done with real-world evidence, that [might be a better] pathway to lower cost than essentially running a randomized controlled trial. For indication extrapolation or switching studies—which are complicated, hard to enroll, and take a long time—those drive cost. 

If they were not part of it or were a lesser part of it, it would change the calculus of what makes a viable commercial opportunity. And I think those are things which, I don't have a crystal ball about when and how these things change, but it's definitely appeared to be an evolving landscape. And there are signals from Europe that there's willingness to explore moving those thresholds. The US has typically been following Europe on that regulatory science approach. And so, it's possible we can see that here. It could be interesting.

Better familiarity with biosimilars is enabling government agencies to reevaluate their approval requirements and encouraging smaller manufacturers to invest in biosimilar development, said Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.

IQVIA's Michael Kleinrock Shares Why Smaller Manufacturers Are Investing in Biosimilar Development

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

findings support a proposed natalizumab biosimilar

 (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).

 for the full year of 2022 showed $1.95 billion of cash proceeds, which was largely driven by the sale of its biosimilar portfolio to Biocon Biologics.

Number 2: Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, 

 from the World Health Organization (WHO) have changed over time and whether those changes are beneficial for biosimilars in part 1 of this 2-part series.

 for its insulin products and cap out-of-pocket costs for insulin, the company shared that it will launch its interchangeable insulin biosimilar, Rezvoglar, at a 78% discount to the originator (Lantus).

The Top 5 Biosimilar Articles for the Week of March 6

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

Number 5: In Cardinal Health’s 2023 Biosimilars Report, more than 60% of surveyed providers said 

they would only want to prescribe adalimumab biosimilars

 with interchangeability designations, suggesting the label may have a greater impact on uptake than originally expected.

Number 4: In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also 

 of the US health care system and its market forces.

Number 3: Panelists at the annual meeting of the International Generic and Biosimilar Medicines Association (IGBA) 

 into the current state of the global biosimilar and generic markets and why government agencies need to leverage these medicines to address challenges in the pharmaceutical space.

 with Formycon for an ustekinumab biosimilar; Similis Bio partners with Novel351K to co-develop 3 biosimilars; and Celltrion Healthcare launched its bevacizumab biosimilar in Japan.

Number 1: Jacqueline Corrigan-Curay, MD, JD, principal deputy center director of the FDA's Center for Drug Evaluation and Research, 

 at Access 2023 on how the Biosimilar User Fee Act and the Generic Drug User Fee Act have developed over the last year.

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

The Top 5 Biosimilar Articles for the Week of February 27

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

Number 5: Alex Jung and Kim Dwyer, both members of the Midwest Business Group on Health (MBGH) board of directors, discussed why employers should be ready for the 

 entering the market, and how they can prepare.

 of its pegfilgrastim biosimilar Stimufend (pegfilgrastim-fpgk), making it the fifth biosimilar referencing Neulasta to enter the market.

Number 3: In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also 

Number 2: At the annual meeting of the Association for Accessible Medicines (Access 2023), 

 explained his dedication to and the inner workings of his online pharmacy that provides generic drugs to patients for significantly lower prices than traditional pharmacies.

Number 1: Biocon Biologics and its partner Viatris 

received a complete response letter (CRL)

 for their biosimilar referencing Avastin (bevacizumab), the second CRL for the companies in 2023. The news comes as Biocon publishes increased revenues for biosimilars and generics.

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

The Top 5 Biosimilar Articles for the Week of February 20

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

Number 5: Amgen’s Amjevita (adalimumab-atto) has 

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

Number 4: IQVIA’s Biosimilars in the United States 2023-2027 report found that while the US biologics market has grown 12.5% annually over the last 5 years, 

 and is expected to reach $129 billion by 2027.

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

 on its Eylea (aflibercept) biosimilar; Sandoz received a thumbs up from the European Union’s Committee for Medicinal Products for Human Use (CHMP); and Shanghai Henlius Biotech began a phase 1 study for its daratumumab biosimilar candidate.

Number 1: Sonia T. Oskouei, PharmD, vice president of biosimilars and specialty at Sandoz, foreshadowed how the 

US market introduction of adalimumab biosimilars

 could influence future biosimilar entrances and discussed why educational efforts need to be tailored to different specialties and stakeholders.

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

The Top 5 Biosimilar Articles for the Week of February 13

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 

 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.

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?

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

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 

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.