Amgen Launches Amjevita® With Two WAC-Based Pricing Options

The adalimumab competition is officially open for business, and Amgen came out of the gate launching Amjevita in two WAC-based pricing options to appeal to a broad market.

One of the biosimilar industry’s main concerns is that adalimumab, the first biosimilar antibody, will be funded and managed through the pharmacy benefit. As such, pharmacy benefit managers (PBMs) will control much of the access, and PBMs base much of coverage on rebate contracts, especially in the adalimumab space. Therefore, maintaining a high wholesale acquisition cost and providing healthy rebates was a formula that helped AbbVie build $20 billion in US sales.

On the other hand, health plans and health systems frequently prefer lower list prices and minimal rebates to attain the same net cost; they don’t rake in the same rebate dollars that PBMs obtain.

Amgen has tried to please both customers. For their Amjevita launch, their base offering is a 5% lower WAC (i.e., $3,288 per 40-mg pen dose) than the reference product Humira®, with significant rebates to arrive at a lower net cost. Alternatively, Amjevita will be available at a WAC discount that is 55% below that of Humira today, without rebating (i.e., $1,557 per 40-mg pen dose). In either of these approaches, Amgen intends Amjevita to be highly competitive with AbbVie’s reference product. It is widely known that AbbVie rebates heavily off its current WAC price of $6,922/mo (chronic doses are administered every other week), estimates range from 40% to 60% (as contracting terms are proprietary, the average net price is not available).

It is anticipated that most of the Amjevita business will be managed through the PBMs, so the high WAC approach should predominate. It is also unclear at the moment if Amgen will widely offer the low-WAC pricing option.

In Other Biosimilar News

Biosimilar penetration in oncology practices exceed 90% in many cases, but a recent study indicated that although they are prescribed very frequently, oncologists are not necessarily highly informed about what biosimilars are. Researchers concluded that just over half of those surveyed understood that biosimilars are not the same as generic drugs, and only one-third knew that biosimilars and reference products do not share the same exact chemical structure and manufacturing process.

Put Your Money Where Your Mouth Is

We are heading down the stretch for the most lucrative biosimilar market that may ever open in the US healthcare system. On January 31, Amgen will launch its long-awaited biosimilar Amjevita®.

The opening of the long-delayed competition for adalimumab marks the latest and most important era in the biosimilar timeline. Personally, I’ve been writing about this day for more than 6 years. I wonder if DraftKings® will be taking wagers on this race?

adalimumab biosimilar launches

There are a few things we do know about how the market will open up, and there are quite a few things we still don’t know for sure. For instance, we know that AbbVie will not cede its $20 billion in US sales to biosimilar competitors. The patent thicket that AbbVie erected for Humira® is testament to its willingness to defend a product that is well past market exclusivity and principal patent expiration. To the extent that AbbVie increases Humira rebates and lowers its retail price will define just how aggressive it intends to be to retain the dominant market share. Whether or not AbbVie follows this path, payers will see big savings from the adalimumab biosimilar launches. I’m betting the payers will be the big winners.

Based on the reporting of the last few weeks, we do know that the PBMs will (1) retain Humira as a parity product in 2023 and (2) be open to add one or more biosimilars to their formularies at parity with the reference product. Based on payer market research and in speaking with individual payer executives, we know health plans, insurers, and perhaps even employer sponsors will utilize the 2023 adalimumab biosimilar launches to set themselves up for 2024 and an intentional movement away from Humira’s market dominance.

In order for that to happen, the biosimilar manufacturers must meet payers’ expectations. That is, they must:

  • Engage in meaningful negotiations for significant savings over the reference brand
  • Come to the table with patient assistance services that approximates what AbbVie has established
  • Make a convincing argument (with or without an interchangeability designation) that use of their biosimilar will result in minimal or no provider or patient treatment disruption

This last bullet is particularly important, because it infers a number of different issues, including ensuring the supply chain and offering enough of the important characteristics of Humira that patients don’t bother their doctors for a return to the innovator brand.

Let’s unpack these for a moment. In regard to the supply chain, does the biosimilar manufacturer have enough backlog to handle greater-than-anticipated utilization? Can its manufacturing facility handle new output (and does it have a history of doing so)? This may be a consideration for Alvotech (which is still awaiting US approval) or Fresenius Kabi, or perhaps even a couple of the more established biosimilar makers.

The other consideration may be more nuanced. Aside from the question of citrate-free or not citrate-free (which the biosimilars are overwhelmingly the former), what of the various injection devices that will be used for each of the new biosimilars? Will patients notice a transition to a new product? Will they be comfortable with the new pen-delivery device, finding it easy to use or not be happy with a different needle size?

Over the years writing about adalimumab development, I have paid little consideration to self-injection devices. An interchangeable biosimilar does not imply that the delivery device is the same, only that the agent can be automatically substituted for the reference product. It will be very interesting to see how this plays out in July, with the launch of most other adalimumab biosimilars.

In the meantime, Amgen will launch Amjevita with a couple of limitations: It will be available in the low-dose concentration only, in a citrate-free version, without interchangeability. The high-dose concentration and interchangeability designation may come in 2024. How limiting are these characteristics? From what we hear, not very. It’s time to see what the market actually does, based on Amgen’s pricing.

Alvotech’s Ustekinumab Biosimilar Application With the FDA: Decision Expected Before End of Year

Alvotech has emerged first out of the blocks in the race to bring a Stelara® biosimilar to the US market. The company announced that the FDA accepted its 351(k) application for AVT02 on January 6, which should position it for a decision in the fourth quarter of this year.

Alvotech had announced a successful conclusion to its late-stage confirmatory trial of AVT02 in May 2022, finding that it was noninferior to the reference product in the treatment of patients with plaque psoriasis. Should the drug be approved, it will be marketed by Teva in the US.

ATV02 is also the first interleukin (an interleukin 12/23 biologic) to be submitted for FDA approval. Others, like secukinumab, will follow in a few years. The principal patent for Stelara is set to expire in September 2023.

The ustekinumab biosimilar competition should be fierce, with up to six biosimilar makers in late-stage trials. Amgen is expecting completion of its multiswitch study in March 2023 for a potential interchangeability designation. The assumption is that Celltrion, Samsung Bioepis, Formycon, and Bio-Thera may enter the fray as well.

In 2022, US revenues for Stelara were approximately $6.5 billion (roughly an 8% increase over 2021), based on results up through the third quarter of last year. The principal patent on Stelara expires in September 2023.

Joseph McClellan, Alvotech’s Chief Scientific Officer, stated, “The progress of AVT04 helps to validate the end-to-end biosimilars development and manufacturing platform that we have built at Alvotech.” He continued, “Our approach is multi-product, and we look forward to broadening our portfolio as we continue to focus on expanding access to affordable biologic medicines.”

Celltrion Files FDA Application for Subcutaneous Form of Infliximab

In November 2019, Celltrion received approval in Europe for its subcutaneous (SC) form of infliximab. At that time, we speculated on the dramatic implications such an approval might have in the US. More than three years later, Celltrion’s US division announced that it had completed its 351(a) submission to the US Food and Drug Administration.

rituximab biosimilar

A potential approval in Q4 2023/Q1 2024 would provide a self-injectable form of infliximab that would easily be covered under the pharmacy benefit of health plans and insurers. As a result, payers generally favor self-injectables over infusibles. This would be stiff competition for the infusible biosimilars on the market. Janssen, manufacturer of the reference product Remicade®, introduced its low WAC-priced, unbranded infliximab infusion last year, perhaps sensing the looming implications of a Celltrion approval, along with the 2023 biosimilar launches of the competitor anti-TNF inhibitor adalimumab.

Currently available infusible infliximab biosimilars include Celltrion’s Inflectra® (marketed by Pfizer), Samsung Bioepis’ Renflexis® (marketed by Organon), and Amgen’s Avasola®. According to the 2022 Amgen Biosimilar Report, Remicade still represents 54% of the marketshare, followed by Inflectra at 29%, and the others with single-digit shares, as of Q2 2022.

Celltrion’s application for the approval of CT-P13 SC was based on phase 3 trials of patients with moderate to severe Crohn’s disease and ulcerative colitis, in both cases compared with placebo. The press release termed this move a “planned initial submission package,” implying others may follow. Whereas infusible Inflectra is currently approved for use in patients with inflammatory bowel disease, rheumatoid arthritis, and other autoimmune disorders, the FDA will likely require additional clinical studies to approve the SC formulation for the broader indication list. It is unclear, however, whether payers will limit the agent’s use to inflammatory bowel disease only if it gains FDA approval.

The reason for Celltrion’s filing a 351(a) biologic licensing application, and not a supplemental 351(k) biosimilar application, is that Remicade was not approved as an SC product. There was no reference product to compare with the SC formulation. In contrast, if Coherus Biosciences does apply for approval of an on-body injector form of Udenyca®, it could hypothetically be compared with Neulasta OnPro®, the reference pegfilgrastim product.

40th Biosimilar Approved: Fresenius Kabi Gets FDA’s Nod on Idacio®

On December 14, Fresenius Kabi announced that the US Food and Drug Administration approved its adalimumab biosimilar, Idacio (adalimumab-aacf). This is the eighth Humira® biosimilar approved, and Fresenius Kabi expects to launch the agent in July, along with several of its competitors.

Idacio is a citrate-free, low-concentration dose formulation of adalimumab. The company has not disclosed whether it has plans to seek approval for a high-concentration dose version in the future.

In the press release announcing the approval, Michael Schonhӧfer, CEO of Fresenius Kabi, stated, “This is another important milestone for Fresenius Kabi in fulfilling our strategic priority of introducing biosimilars for patients worldwide.”

Idacio had been marketed in the EU since 2019. This marks the second US biosimilar approval for Fresenius Kabi; Stimufend®, a pegfilgrastim biosimilar, was licensed in September 2022. the company filed the first 351(k) application for approval of a tocilizumab biosimilar in August 2022. It is also working on an investigational biosimilar for denosumab.

There are now 40 biosimilars approved since the opening of the FDA’S biosimilar 351(k) pathway in 2012.

PBM Trade Association Offers Key Changes to Improve Biosimilar Competitiveness

According to the Pharmaceutical Care Management Association (PCMA), biosimilars can play a much more influential role in managing the cost of specialty pharmaceuticals; however, the federal government will have to take stronger initiatives to make that happen.

The trade organization’s white paper “PBMs Support the Proliferation and Use of Biosimilars” outlines some key steps that could change the landscape of biosimilar development and introductions in the United States. The PCMA issued its recommendations on the eve of the first adalimumab biosimilar launch, the first of the major biosimilars to be managed by pharmacy benefit managers (PBMs).

First, PCMA urges that current market exclusivity be reduced from the current 12 years to seven years, which “would provide sufficient financial return for manufacturers while speeding biosimilars to market.” This was a stipulation the Obama Administration had fought for in the original biosimilar pathway legislation.  

Second, the organization seeks prohibitions on patent thickets and product hopping. Calling both practices “anticompetitive,” the former results from the filing of redundant and overlapping patents that serve no purpose but to delay competition. In the case of product hopping, the reference manufacturer makes a relatively minor change to a product in an effort to create a new pharmaceutical that has its own exclusivity cycle, and seeks to shift patient utilization from the older product to the newer one, to avoid biosimilar competition.

Third, PCMA recommends outlawing “pay-for-delay” agreements, which “allow brand drug and biologic patent holders to pay potential competitors to delay market entry” of biosimilars or generics. Technically, if the first two recommendations were enacted, there would be little incentive for a biosimilar manufacturer to participate in a pay-for-delay agreement, which would also halt any patent litigation.

Finally, the organization suggests removing the interchangeability designation. This makes some sense, as the term is ultimately confusing and potentially hinders utilization of “noninterchangeable” biosimilars, without a basis in science.   

None of these recommendations would be simple to implement, requiring statutory and/or regulatory action, which could take years to cultivate. However, most of these points are echoes of previous calls in the past.

The effects of these actions would be undeniable and disrupt the pharmaceutical industry’s profits and pipeline. Perhaps that is why the pharmaceutical manufacturers trade association, PhRMA, was quick to counter in an Email to Politico, “These [PBM] proposals are anti-innovation and will limit patient access to the next generation of cures. When they support reforming the rebate system, we will take their alleged concerns more seriously.” Yes, well, touché.

Biogen Announces Submission of Its 351(k) Application for Actemra® Biosimilar

Competition is heating up in a new drug category. Biogen announced today that the FDA has accepted its biosimilar application for BIIB800 (also known as BAT1806), a potential competitor to the reference product Actemra (tocilizumab). This is the second tocilizumab biosimilar sent for approval by the FDA. In August, Fresenius Kabi announced that it filed its own application for MSB11456.

An interleukin-6 receptor monoclonal antibody, Actemra is indicated for several autoimmune disorders, including rheumatoid arthritis, and juvenile idiopathic polyarthritis and arthritis. Biogen’s phase 3 clinical trial was conducted in patients with moderate- to severe rheumatoid arthritis, demonstrating equivalent clinical efficacy and safety outcomes with the reference product. The trial was completed in 2021, and results reported in June 2022 at the European Congress of Rheumatology.  

Development of this biosimilar is the result of a partnership between Biogen and China-based Bio-Thera Solutions. This biosimilar is also under review by the European Medicines Agency.

Roche announced US revenues in 2021 of $1.9 billion on Actemra, and it is trying to maintain its share by moving patients to a subcutaneous formulation (Biogen’s biosimilar tests were conducted with an infusible form only). Fresenius Kabi’s testing was conducted with the subcutaneous formulation.

A portion of Roche’s revenue had been associated with its emergency use authorization for patients hospitalized with COVID-19 (for example, sales of the agent in third-quarter 2021 were 57% higher than sales in the third-quarter 2020). This raises the question of whether the FDA will also consider extrapolation to COVID-19 use in its decision, which is expected in the late fourth quarter of 2023.

Beyond Fresenius Kabi and Biogen, the only manufacturers that have publicly announced their intention to develop a tocilizumab biosimilar is Celltrion, which is completing a phase 1 study.

In Other Biosimilar News

Express Scripts joined OptumRx in announcing its intention to add multiple adalimumab biosimilars onto its preferred formulary next year. No information about timing or specific biosimilar inclusions is available at this time.

Viatris has begun a switching trial of its Hulio® adalimumab biosimilar, with an eye towards completion in October 2023. This trial is being conducted with the low-dose concentration of the product. This could mean a Q3-4 interchangeable designation for this formulation.

J&J Slaps Patent Suit on Amgen Over Impending Stelara® Biosimilar

Patent litigation over biosimilars charges forward, with a new lawsuit filed on November 29 by Johnson & Johnson’s Janssen unit over Amgen’s efforts to bring a ustekinumab biosimilar to the marketplace.

Stelara is expected to be a hotly contested market, with five manufacturers completing phase 3 trials through the first half of 2023. The principal patent expiration is in September 2023. Amgen completed its phase 3 clinical trial last summer and is scheduled to complete a multiswitch interchangeability study in March 2023.

The US revenues for this interleukin 12/23 agent, used to treat autoimmune disorders including Crohn’s disease, ulcerative colitis, and psoriasis, were $5.9 billion in 2021, which represented a 13% increase over 2020.

Amgen has not officially announced a 351(k) filing for ABP 654, but in its November 2 third-quarter financial statement, it hinted that this might be the case, saying “A phase 3 study evaluating the efficacy and safety of ABP 654…in adult patients with moderate to severe plaque psoriasis has completed, and these data were submitted to the FDA to support U.S. approval.”

If true, the first interleukin biosimilar could be ready for marketing as early as the patent expiration in September 2023, and an interchangeability designation could follow in 2024.

Competition is expected to be fierce in this category, with Alvotech, Bio-Thera, Celltrion, Formycon, and Samsung Bioepis in the mix during the 2024 time frame.

In Other Biosimilar News  

An article in JAMA Internal Medicine states that approvals of biosimilars with “skinny labels” (i.e., those approved for only some of the reference product’s indications) have saved Medicare $1.5 billion during the period from 2015 to 2020. This figure is based on utilization of five drugs. Two thirds of biosimilars are approved with skinny labels, including the adalimumab biosimilars. Though the adalimumab approvals are for limited indications, these skinny labels aren’t skinny at all–they represent the lion’s share of Humira® prescriptions today.

A Conversation With Ian Henshaw

It has been a busy year for biosimilars at Biogen, starting early in the year with with the sale of its stake in Samsung Bioepis. During Global Biosimilars Week, we interviewed Ian Henshaw, Biogen’s Senior Vice President and Global Head of Biosimilars, to get his perspectives on what the coming year has in store.

BR&R: What is your perception today of the state of the U.S. biosimilar industry, and how does it compare with the biosimilar industry in the European Union?

Ian Henshaw

Henshaw: It’s clear that the U.S. biosimilars business is catching up and accelerating, particularly with the launches of the three oncolytics—rituximab, trastuzumab, bevacizumab. We’re starting to see health care systems become more organized towards the potential of biosimilars to save money, increase patient access, or improve the quality of care for patients. That is exciting and good for U.S. patients, good for the U.S. health care systems, and they are catching up with Europe.

BR&R: It’s particularly exciting now, as we head into 2023 and the launches of adalimumab biosimilars. OptumRx just announced their decision that Humira® will not be the only choice of adalimumab, that up to 3 biosimilars will be at parity with the reference product. Other major pharmacy benefit managers and other U.S. payers will be revealing their decisions in the next few weeks, at least hinting at which biosimilars or how many will be covered.    

Henshaw: Yes, I completely agree. Biosimilars of Humira in the United States is another chapter within the “book of biosimilars.” We look forward to seeing what happens there.

BR&R: What was Biogen’s experience with EU launch of adalimumab biosimilars in 2018?

Henshaw: Well, three biosimilars were launched on nearly the same day, and then two or three biosimilars were added within six months. It was very competitive from day 1. In terms of commercialization processes, we had to deal with several different types, as you well understand. Some markets started with contracts, some with tenders, and pricing and reimbursement activities had to start at that point. Of course, a lot of additional customer interaction was involved, particularly with pharmacists, physicians, and payers. This created a whole new level of excitement within Europe. Within a short period of time, the total number of patients being treated with the molecule, innovator plus biosimilars, had grown significantly.

BR&R: Fast forward to 2022. Has the number of manufacturers competing with adalimumab biosimilars dropped off? Or has each competitor attained a sustainable marketshare?

Henshaw: That’s a good question. First, we should go back a couple of steps and ask, “who has developed through to phase 3 trials?” and then, “who has filed for approval?” The answer is that not every manufacturer has filed in Europe. For those attaining approval and launching, you’ll see that all entrants have generally made progress. It is time dependent though; the ones there at the beginning are probably achieving the better results.

Global Biosimilars Week

BR&R: [Last week closed] the 2023 Global Biosimilars Week. Why do you think it is important that the Global Biosimilars Week efforts and Biogen’s support of it continue? What do you think is the strongest attribute of Global Biosimilars Week?

Henshaw: With an aging population and the COVID-19 pandemic slowly receding into the past, biosimilars offer a key to unlock the potential for patients who need the specific pharmaceuticals in question and/or treatments that are innovative and new. You get a great dynamic when biosimilars are added to the availability of biologics or advanced biologics. That’s point number 1.

Point number 2: If you break it down into the competition piece, the stakeholders probably settle first on what they can save in terms of health care costs, which, of course, is what you hear. Then it transitions very nicely into increased access, as we’ve seen widely across Europe, which is a great thing.

Point number 3: You see very good case studies where, adding in additional resources or education and services, you obtain a much higher patient quality of care or pathway of care.

These three—savings, increased access, and the quality of care—result in the big win here.

BR&R: Where do you think is our biggest gap in terms of biosimilar understanding and adoption in the United States?

Henshaw: First of all, there’s still, in some therapeutic areas, the question around the quality of biosimilars. This is not new, but perhaps at a different stage. The questions around efficacy and safety have been fully qualified by the regulators, generally.

Then you get to the point of uptake. Are biosimilars for treatment-naïve patients only? Or for patients who are established on reference drug therapy? What is the process?

Dare I say that the reimbursement of some of the drugs, whether through buy-and-bill and/or Medicare part B, in most cases that we’ve seen, is something that needs to be worked through in terms of insurance parity coverage.

Adalimumab will be the first major product to be reimbursed through part D. As mentioned earlier, we look at that as a new chapter. That’s where you’ll start to see that speed up, once the second and third part D biosimilar products are approved. There is still some learning for systems across payers, PBMs, and the government organizations.

BR&R: From a regulatory and legislative standpoint, what steps still need to be taken to enable the biosimilar industry to flourish?

Henshaw: The regulators have an important job: They ensure comparability between the biosimilar and the innovator. As we progress, we’re looking more at how biosimilars compare relative to each other. The majority of that analysis continues to be in the early technical proof of biosimilarity and the body of evidence that is done in the technical and process piece. It is supported by phase 1 pharmacokinetic and pharmacodynamic studies. The ongoing debate at the moment is about the future need for phase 3 data. I believe that if you reduce the need for phase 3 data, you remove time from the development process and you potentially increase competition. With that, you may have a different scenario at some point in the future.

BR&R: How do we make that happen?

Henshaw: You have to dialogue with the regulatory bodies directly about what is important and to establish comparability as part of the biosimilar package. That is where industry, as a whole, can help lead the discussion.

Biogen’s Biosimilar Path Going Forward

BR&R: Biogen has deep roots in biosimilar development, especially considering its long joint venture with Samsung Biologics in Samsung Bioepis. Biogen sold the equity stake in Samsung Bioepis in January—did that signal a change in direction for Biogen on biosimilars?

Henshaw: The joint venture, Samsung Bioepis, successfully brought to market six or seven different products in the last 10 years. That’s great news. We have commercialization rights for  five of those ourselves. We continue to support and commercialize that aspect of the business.

Both Samsung Biologics and Biogen joined with the same intent, and that intent continues to bring more biosimilars to the marketplace. As you will see from our pipeline, we also secured a biosimilar of Actemra® and a biosimilar of Cimzia® around the same period. At Biogen, we will continue that journey, continue to unlock the potential which we believe in, and continue to transform more lives across the therapeutic index.

BR&R: Several of the biopharmaceutical companies, like Amgen, Pfizer, and Biogen, produce both reference products and biosimilars. How does Biogen straddle that balance? 

Henshaw: Societally, there’s treating patients with advanced biologics whether they are an innovator or any original form, and then making those advanced biologics as biosimilars is in fact the same intent. You have a scenario, which we have seen around the world and particularly in Europe, where you have savings generated from biosimilars, and that creates headroom for additional patients to be served within that particular therapeutic area. It also creates headroom for the new, innovative products that we have in our pipeline or just brought to market.

That is actually a very good balance to bring to the health care systems, as we consider aging populations, more demands, higher health care expenditure generally.

Like the other companies you mentioned, Biogen has that ability to apply not only that in terms of commercialization and intent but also to deploy our parentage or experience—in our case, 40- plus years of biologics, manufacturing, and technology. I think that is where you start to see synergies.

BR&R: Straddling that balance also optimizing the lifecycle of reference products. For instance, Sandoz is trying to introduce a biosimilar for natalizumab for multiple sclerosis, and unsurprisingly, Biogen recently filed patent litigation to delay the launch. The push–pull balance of these companies who are developing biosimilars and reference drugs fascinates me. The intellectual property aspect of a reference manufacturer doesn’t mesh well with biosimilar commercialization.

Henshaw: It is about balance, as you covered here. We cannot comment on ongoing regulatory reviews or litigation.

BR&R: Let’s go back to one specific area you mentioned: Biogen’s acquisition of the rights for a Cimzia® biosimilar. Cimzia has been around for quite some time, without biosimilar competition (perhaps due to the difficulty to manufacture it and a patent thicket from UCB). We cannot find publicly available information from another manufacturer who intends to produce a biosimilar for Cimzia.

How does Biogen actually view the opportunity with a product like Cimzia?

Henshaw: I think you make a good point with Cimzia. There are probably undeclared developers on this product, so that will continue to evolve. The process and the technology associated with it is advanced, and I think Biogen, with its heritage, can apply some of its insight there. That’s where it comes through. At the end of the day, whether it is a Cimzia biosimilar or others that are coming, or past and present, they all have the same impact.

There are biologics out there that may not make the threshold for development: pediatric, orphan drugs, etc. There may not be enough revenue to turn them into a profitable or sustainable biosimilar business. That’s where we should be focusing our debate, again, referencing some of the pathways and partnerships that need to happen.

Today, we see a lot of focus by the major players on the same products, but you won’t have that same focus across the spectrum of biologics that have been approved for use and may be eligible candidates for biosimilar development. So, you get this “crowding” situation.

The great news is, with Biosimilars Week, there are 600 biosimilars that have been approved across the world, but if you then look at the 89 that are approved in Europe, they are only from 19 molecules. Have we had a good start on some products and are we learning a lot? Yes, we are. Is there more to go in terms of time and efficiencies and partnership in this space? Yes.

I get hopeful particularly for what it will do in terms of increasing patient access as well as savings. But the greater the access, the better the quality of care.

BR&R: I’m going to pin you down. Three years from now, how many approved biosimilars will available for use in the United States?

Henshaw: I would answer in terms of different molecules as opposed to approved products. I think in 10 years you’ll be knocking 40, but let me be distinct: that’s not total number of approvals. That’s different variations of it.

BR&R: Right. Well, that’s fairly encouraging.

Henshaw: And it’s good for humanity.

Lilly’s Rezvoglar Joins the Ranks of the Interchangeable Insulins

On November 16, the Food and Drug Administration (FDA) granted its second interchangeable designation to an insulin glargine product, Rezvoglar®, manufactured by Eli Lilly. Rezvoglar was first approved as a biosimilar in December 2021.

Viatris’ Semglee® was the first glargine product given the interchangeable designation, in July 2021 (it was originally approved as a 505(b)2 agent, not a biosimilar).

Both products are considered interchangeable with the reference product Lantus® only. This category is extremely competitive; in addition to the interchangeable insulins, there is a follow-on agent (Lilly’s Basaglar®), an authorized low-cost biosimilar (a nonbranded version of Semglee), other long-acting insulin brands (e.g., Toujeo®), and the anticipated entry of another low-cost biosimilar from Civica in 2024.

In other biosimilar news

More real-world evidence is being compiled on the safety and efficacy of switching noninterchangeable biosimilars. The latest comes from a review of prospective trials, observational studies and case reports conducted on adalimumab, infliximab, and etanercept biosimilars used for the treatment of psoriasis. The data were largely from Europe, of course, as adalimumab and etanercept biosimilars were not available in the US at the time of the analysis.

The authors conclude, “Efficacy and safety profiles of adalimumab, etanercept, and infliximab biosimilars are similar to those of the reference products in real-world use, supporting the practice of switching patients from these biologics to approved biosimilars when possible. The real-world evidence is consistent with controlled trials and may be reassuring to patients and providers.”