According to a study published in JAMA Internal Medicinethis month, the approval and launch of the follow-on insulin glargine product Basaglar turned the tide on rising costs for this long-acting insulin.
Approved as a 505(b)2 insulin in August 2014 (prior to the category being transitioned to the 351[k] biosimilar regulatory pathway), Basaglar was the first competitive launch to challenge Lantus®. From 2010 to 2014, according to investigators from Johns Hopkins’ Bloomberg School of Public Health, the wholesale acquisition cost (WAC) of Lantus was rising on average 4.9% per quarter. During that period, the WAC jumped from $9.23 to $22.21 per 100 IU. Estimated net prices were supplied by the SSR Health Drug Database, and these also rose, but at a 3.8% quarterly clip, to $12.79 in 2014.
Basaglar was not launched by Eli Lilly and Boehringer Ingelheim until late 2016, and although Lantus’ WAC remained steady at that time, its estimated net cost dropped by 5.2% per quarter. Basaglar captured as much as 41% of the net glargine sales by Q1 2020, compared with 46% for Sanofi’s Lantus. The rest was attributed to Sanofi’s high-concentration follow-on brand, Toujeo®, which was introduced in 2017, most likely as a tool to offset eroding Lantus’ sales.
The next entrant into the glargine competition, Semglee® was approved later in 2020, and so did not register any marketshare at this point. However, Semglee was initially approved later in 2020 as another 505(b)2 agent, and did not register any marketshare at this point.
This week, the Center for Biosimilars reported that Viatris and Biocon’s product, which in July received approval as both a biosimilar and interchangeable glargine, grabbed preferred status on Express Scripts’ primary national formulary. This, and other potential PBM contracts, may have significant effects on both the marketshare profile of the category and on net pricing over upcoming quarters. In this article, Express Scripts asserted that it will save $22 million a year on the switch.
The researchers noted that this research did not consider the possible effect of other long-acting insulins (detemir or degludec) on WAC or net prices in the category. However, it is clear that increasing competition from Semglee and perhaps new follow-on and biosimilar launches will assure the continuing downward slide of Lantus’ and Toujeo’s net costs, as payers reevaluate their formulary preferences for 2022.
On October 15, Boehringer Ingelheim formally secured its long-sought adalimumab interchangeability designation from the Food and Drug Administration (FDA). This label was earned based primarily on the results of Boehringer’s VOLTAIRE-X switching studies. The VOLTAIRE-X study demonstrated that patient efficacy or safety outcomes were not affected by multiple switches between Cyltezo and Humira®.
Once launched, Cyltezo will be able to be automatically substituted at the pharmacy for the reference product Humira for all its listed indications. Individual state pharmacy laws specify whether and how prescribing physicians need to be notified of any switches made by the pharmacy.
Cyltezo is not scheduled to launch until July 1, 2023, however, based on Boehringer’s settlement with AbbVie. Cyltezo will be available as a citrate-free, low-concentration dose biosimilar.
In its press release, Boehringer Ingelheim’s Senior Vice President, Medicine and Regulatory Affairs, Thomas Seck, stated, “We are proud to be the company driving the advancement of biosimilars and delivering the first and only nterchangeable biosimilar with Humira. It is a true milestone and an important step forward for broader adoption in the US and for patient access to affordable medicines.” He continued, “The interchangeability status of Cyltezo reinforces our goal of expanding overall treatment options and contributing to the quality and sustainability of the US healthcare system.”
Currently, Alvotech is the only other biosimilar adalimumab developer to publicly announce that it is seeking FDA approval as an interchangeable biosimilar.
With the Food and Drug Administration’s (FDA’s) recent approval of the first interchangeable insulin, Viatris and Biocon’s Semglee®, some questions may begin to be answered with respect to payer coverage, automatic substitution, and their potential for success in the marketplace. However, unlike the other biologic drug categories, there are additional levels of complexity among the insulins that may affect future competition.
At the DIA Biosimilars 2021 conference last week, Stephanie Ho, PharmD, Pharmacist Evidence Analyst & Strategist, Kaiser Permanente, spoke about how biosimilar insulins may impact payers. Her virtual presentation implied some very interesting issues, and this post will explore some of them.
Insulin Is One Category, not One Drug
First, we must remember that insulins come in several varieties—all necessary to treat a spectrum of patients. These include long-acting (e.g., insulin glargine, detemir, degludec), rapid-acting (e.g., insulin lispro, aspart, glulisine), short-acting (e.g., regular), intermediate-acting (e.g., NPH), and premixed combinations (e.g., 70/30, 50/50, 75/25 mixes). The currently approved and available follow-on products include Basaglar® and Toujeo® for glargine (Lantus®) and Admelog® for lispro (Humalog®). These were approved through the 505(b)2 pathway prior to the formal insulin transition to biosimilars in March 2020.
The only currently approved insulin biosimilar (and interchangeable) is Semglee, which is also a long-acting glargine product. Originally, this agent was approved as a follow-on, as it raced to beat the transition deadline for submission as a biosimilar. The only authorized generics available for insulin are Lilly’s lispro and Novo Nordisk’s aspart, unbranded fast-acting insulins.
Authorized Generics or Authorized Biologics?
That said, there are no authorized generics in the same category of a biosimilar insulin—yet. Dr. Ho noted that the price of insulin glargine more than doubled between 2010 and 2019. Based on the current regulations, can Sanofi, manufacturer of the reference product Lantus, bring out what would now be called an “authorized biologic”? It’s an intriguing question, but it may be more academic than real; Sanofi already has its follow-on insulin glargine product, Toujeo.
Lilly and Novo Nordisk introduced their authorized generics in 2019 and 2020, respectively, to release the growing pressure placed on them by Congress, which was scrutinizing the large, unjustified increases in insulin prices.
These authorized generics cut the existing rapid-acting insulin prices by around 50%, according to GoodRx. According to data from Amerisource Bergen and presented by Dr. Ho, Walmart was advertising the generic at a price that was 75% below the NovoLog’s list price. As you might imagine, Lilly and Novo Nordisk are not marketing the authorized generics, preferring instead to focus on their higher-priced brands. Still, it raises the question as to whether there could be a market for biosimilar rapid-acting insulins. If they would compete against the authorized generics and not the brands, the biosimilar opportunity could be very limited indeed.
Interchangeability and the Authorized Generic
From a practical perspective, there is no difference between the authorized generic for insulin lispro and Humalog, for example. Lilly simply sells it without the brand name but with the same pen-delivery system. Barring manufacturing drift, it is the same formula, made in the same way, with the same clinical effect. If that isn’t an interchangeable biologic, what is?
Somewhat surprisingly, the health plans and insurers haven’t automatically substituted en mass Humalog and Novolog for lispro and aspart. Perhaps there is portfolio contracting at play here, which may prevent such a move. That may seem reasonable, as both Lilly and Novo Nordisk offer several types of insulin.
Consider also that some plans have switched Basaglar for Lantus in the glargine category, without apparent clinical consequences for switch. By that same consideration, plans were not required to cover both Humalog and Novolog rapid-acting insulins; when changing health plans, patients would take whichever was covered by their new insurer or pharmacy benefit manager.
The unique complexities of the insulin market will certainly affect the potential market dynamics for prospective biosimilar makers. Novo Nordisk can limit the success of a new biosimilar insulin detemir by either introducing its own authorized biologic or by simply cutting the price of its originator brand. It could be a real consideration of a manufacturer developing additional biosimilars for different insulin types.
The question of interchangeability for biosimilars has haunted the US Food and Drug Administration since the promulgation of the Biologics Price Competition and Innovation Act of 2010. The FDA’s draft guidelines on interchangeability evolved very slowly, and the biosimilar industry had to work to (1) keep up with the guidelines as they gained clarity, (2) tirelessly wage war on misinformation as to what an interchangeable biosimilar actually represented, and (3) grasp the value of interchangeability as a for-profit enterprise and whether to charge forward with the necessary clinical trials.
In this column, we have often addressed the interchangeability designation, and how it may be perceived. Leaders in the industry, like Hillel P. Cohen, PhD, Executive Director, Scientific Affairs, Sandoz, have hammered home strong arguments that interchangeable biosimilars are not “better drugs” than their noninterchangeable brethren. They are simply subject to additional switching studies to confirm their clinical similarity to the reference product. That does not mean they are more similar to the reference product than a standard biosimilar.
At the 2021 DIA Biosimilars conference held virtually this week, Dr. Cohen restated logic that may be obvious but less often discussed: if two biosimilars are deemed highly similar to the same reference product, those two biosimilars, through the Law of Transitivity, should be highly similar to each other.
Though logical, the concept of biosimilar-to-biosimilar interchangeability is not acknowledged on a regulatory basis. However, the potential for biosimilar-to-biosimilar switching is undeniably real.
Biosimilar-to-Biosimilar Switching Likely to Occur
A large proportion of patients receiving chronic therapy with biologics will no doubt change health plans or insurers over time. This happens voluntarily (e.g., they may choose a lower-price plan from year to year) or involuntarily (i.e., their employer changes the plan offering from one year to the next). These plans utilize their own drug formularies. Considering the launch of perhaps eight adalimumab biosimilars in 2023, health plans will likely prefer different preferred adalimumab products, based on the contracting offers they receive or the characteristics of the biosimilar (e.g., citrate free, high-dose formulation, interchangeable). The same can be said for insulin products, infliximab, ranibizumab, and even chronically used oncology agents. Assuming that is the case, biosimilar-to-biosimilar switching may be somewhat common in 2025.
Is that an issue? Likely not, said Dr. Cohen. He believes that any immunogenicity concern is a hypothetical argument, “and no empiric evidence exists to support the concern. Furthermore, no data has been published to support immunogenicity on a mechanistic basis.” The biosimilar is highly similar not only in efficacy and safety but also with regard to immunogenicity.
What the Data Say
Most of the available data on biosimilar switching comes from Europe, where biosimilars have accumulated over 2 billion patient treatment-days of exposure. Countries adopt whichever biosimilar has the lowest price, based on tendering systems. This may mean that more than one biosimilar is accepted, and these tenders can change from year to year. The regulatory concept of interchangeability does not exist in the EU, and switching may occur in both infusible as well as injectable agents.
Dr. Cohen pointed out that published studies of biosimilar-to-biosimilar switching, based on the European experience, amount to 12 trials, all of which used observational data. Two trials involved adalimumab, eight infliximab, one etanercept, and one involved rituximab. These totaled 1,223 patients. Additionally, 8 studies were reported as meeting abstracts, six of evaluated infliximab biosimilars, and one each for adalimumab and etanercept. Those trials totaled 1,295 patients. Although the studies varied in terms of their limitations and design rigor, they were consistent in finding no differences in patient clinical outcomes, immunogenicity, or pharmacokinetics and pharmacodynamics.
“From a scientific matter, we can trust biosimilar-to-biosimilar switching,” stated Dr. Cohen. “There have been no safety issues, and we’ll very likely have more (observational) data in upcoming years.” If the data continue to show no significant issues, “it would be reasonable to conclude that biosimilar to biosimilar switching does not have any clinical impact.”
Observational data will have to do here, as no biosimilar manufacturer would reasonably spend the money to conduct a randomized, controlled head-to-head trial with another biosimilar.
The Declining Value of Interchangeability Over Time
The inevitability of this discussion has a noteworthy effect: It lowers the value of an interchangeable designation over time. Consider the adalimumab situation, which is similar to one we posed a few years ago: A health plan decides to prefer biosimilar C, which is designed by FDA to be interchangeable to Humira®, around mid-2023. In doing so, the plan places an NDC block on the reference product, and moves to convert as many patients as possible to interchangeable biosimilar C. It achieves more than 80% conversion through substitution at the pharmacy or specialty pharmacy. However, the plan is offered a far better price in 2024 on biosimilar F, a noninterchangeable drug. Biosimilar C no longer has an interchangeability advantage. All of the patients who were converted from Humira were already converted. And biosimilar C is not considered interchangeable (by the FDA) with any approved biosimilar. Payers, however, will likely consider these agents freely switchable with each other, depending on how much weight the payer gives to citrate status and dose concentration characteristics of the products.
What does interchangeability mean in the realm of insulin products? We’ll delve into that rabbit hole in the next post.
With the intensity of horse trading that is underway on Capitol Hill, it is difficult to keep up with the latest developments on a number of areas that may affect the biosimilar industry. However, one measure was passed by the House Judiciary Committee on Wednesday with a large bipartisan margin; coupled with Senate clearance by its own Judiciary Committee in July, this might point to inclusion in the final reconciliation bill that is currently occupying both the executive and legislative branches.
This proposal would attempt to prevent reference drug manufacturers from filing patents that would result in very minor chemical alterations but drastically extend product exclusivity. It effectively limits the number of patents a reference manufacturer can assert, which would cut away much of the extraneous litigation associated with “patent thickets.”
Another proposal would help speed biosimilar agents to market. This proposal includes a curb on the use of citizen’s petitions to the Food and Drug Administration by reference manufacturers to try to derail a biosimilar developer’s track to FDA approval. This would apply both to generic and biosimilar drugs.
A third part of the proposal addresses pay-for-delay patent arrangements, which give reference manufacturers the ability to extend their monopoly on a pharmaceutical by paying generic or biosimilar competitors sums of money to delay their entry into the marketplace.
US Representative Jerrold Nadler (D-NY), Chairman of the House Judiciary Committee, said in a statement, “The streamlining of patent disputes is especially complicated by an emerging practice referred to as ‘patent thicketing.’ This is when a manufacturer seeks to prolong its exclusive rights to market a drug by seeking a voluminous number of patents with an eye towards fending off biosimilars attempting to enter the market.
“H.R. 2884 will help to address these tactics and ultimately, to lower drug prices. The legislation limits the number patents that the brand-name manufacturer can assert in litigation, which forces the manufacturer to focus on its key patents with the goal of streamlining the resolution of disputes with companies that want to sell biosimilar versions of that biologic.”
Using data from IQVIA, the Amgen Biosimilars Trend Report released this month laid out the latest market data on how biosimilars are faring in the categories outside of insulin.
The data emphasize one key trend: Biosimilar competition drives down the average sales price (ASP) of the category; this happens quickly for many categories, even those with modest discounts at launch. Please note that the ASP accounts for pricing discounts and rebates based on wholesale acquisition costs, but it is not a perfect comparator (e.g., there is a lag in ASP reporting, and it does not fully account for other types of contracting, such as portfolio pricing).
Date of First Biosimilar Launch
Drop in Reference ASP Since Biosimilar Launch*
Greatest ASP Difference Between Biosimilar and Reference Drug*
*As of Q2 2021. Adapted from 2021 Amgen Biosimilars Trends Report, based on IQVIA data. †The ASP difference in Q2 2021 between Granix (a follow-on agent) and Neupogen is 63%. ‡The ASP decline of the reference product is greater than that for the biosimilars as of Q2 2021.
Three trastuzumab biosimilars were, according to data based on ASP pricing in Q2 2021, at least 38% below the ASP of the reference product at the time of biosimilar introduction (Ogivri, Kanjinti, and Trazimera). The ASP of Viatris’ Ogivri® is now at 45% below that for Herceptin® in Q3 2019. The reference product’s ASP has fallen by 12% since that time. The other trastuzumab biosimilars have discounts closer to 25%. The total biosimilar marketshare has climbed to 70%, led by Kanjinti (44% total marketshare), followed by the reference product, at 30%.
Similar to trastuzumab, biosimilars for bevacizumab have captured 69% of total volume. The reference product has less than one-third of the market, and Mvasi® has nearly half. Mvasi, which launched in Q3 2019, is now priced 36% below the ASP of Avastin® when the biosimilar first launched. Avastin’s ASP has dropped 11% during that time. The ASP of Zirabev® is also 31% below the Q3 2019 reference price (largely based on an initial 19% discount on Zirabev at launch in Q1 2020).
Rituximab biosimilars have shown similar declines in pricing, with Truxima® having a 36% lower ASP price today compared with Rituxan®’s ASP price in Q4 2019. However, the ASP price of Rituxan hasn’t moved much (only down 6%) over that time. Biosimilars account for 55% of the marketshare, but Rituxan at 45% retains the greatest share by volume. Truxima and Ruxience® are neck and neck, at around 27%–28%.
The pegfilgrastim figures are a bit more notable for one reason—the reference product (Neulasta®) has experienced a 41% drop in ASP price since the introduction of Fulphila® in Q3 2018. Both Fulphila and Udenyca® have experienced similar ASP declines (40% and 36%, respectively), but their actual ASP is not all that different from Neulasta’s as a result. Neulasta Onpro® retains half of the marketshare in this category, with Udenyca second at 18%. Biosimilars account for 37% of the share by volume.
The oldest biosimilar category in the US is that for filgrastim, and Amgen’s reference product Neupogen® has notseen virtually any reduction in ASP pricing since the Q3 2014 launch of Sandoz’s Zarxio®. However, the relative ASP reductions since that time of all of the other competitors exceed 55%, with Zarxio’s ASP drop reaching 64% in Q2 2021. It is not surprising that Sandoz has captured 54% of the marketshare. Teva’s Granix®, the 505b2 agent that predated the biosimilar approvals, is similarly discounted and accounts for 17% of the share by volume.
The epoetin alfa category has only one biosimilar competitor, and Retacrit® currently holds 30% of the market. The ASPs of Retacrit and the reference products Epogen® and Procrit® have dropped 25%-30% below that from Q4 2018.
Even though Remicade®’s marketshare of the infliximab market is only slowly eroding, the big story is that the ASPs of the reference product and the biosimilar competitors are 50% or more below the ASP of Remicade when Inflectra® first launched in Q4 2016. In Q2 2021, Pfizer’s Inflectra marketshare has clawed its way to 17%, while Remicade’s portion is down to 74%.
Partners Samsung Bioepis and Biogen announced today in a press release that their 351(k) application for its ranibizumab biosimilar (reference product, Lucentis®) gained approval from the Food and Drug Administration. Dubbed Byooviz™, this injectable product is the first biosimilar to be approved for ophthalmologic indications.
Formerly referred to as SB11 and now designated ranibizumab-nuna, the drug approval includes the following indications:
Macular edema following retinal vein occlusion (RVO)
Myopic choroidal neovascularization (mCNV)
In August, Byooviz gained approval in the EU and in the United Kingdom. “In the United States, approximately 11 million people are affected with AMD and the prevalence of advanced AMD is growing due to the aging population. The approval of the first ranibizumab biosimilar in the US is a monumental milestone for people living with retinal vascular disorders in the US,” said Kyung-Ah Kim, Senior Vice President and Development Division Leader, at Samsung Bioepis. “The approval of Byooviz underscores our continued commitment to providing valuable treatment options for people who do not have access to life-enhancing biologic medicines around the world,” she added.
The 351(k) application was first filed November 18, 2020. Under their commercialization agreement, Biogen will market Byooviz in the US. Another Samsung Bioepis ophthalmology biosimilar, SB15 (aflibercept), will be subject to the same arrangement once FDA approval is achieved.
Don’t expect to see the launch of Byooviz anytime soon, however. Samsung Bioepis also disclosed that it had signed a licensing agreement with Genentech (Roche), which prohibits the partners from marketing the drug in the US until June 2022 (“before expiration of Genentech’s applicable supplementary patent certificates”), according to the press release. The main US patent for Lucentis expired in June 2020.
Although the US market for ranibizumab has dipped because of competition from compounded bevacizumab and loss of share to aflibercept (Eylea®), the market for ranibizumab could still be over $1 billion. The FDA approval of Byooviz was based in part on the results of a multicenter Phase 3 study of SB11 versus Lucentis in patients with wet AMD. The results were positive for the biosimilar and demonstrated no significant differences in pharmacokinetics, safety, or immunogenicity between the two comparators through week 52.
The ophthalmologic biosimilars will be a highly competitive market, with upcoming biosimilars for not only ranibizumab, but also for aflibercept, and the potential for a manufactured version of bevacizumab for ophthalmology indications. Furthermore, Genentech is introducing a new port-delivery system that could affect the need for monthly intravitreal injections.
Bio-Thera Solutions has partnered with London-based Hikma Pharmaceuticals on its proposed ustekinumab biosimilar BAT2206. The agreement will give exclusive rights to commercialize BAT2206 in the US after FDA approval, with the potential for marketing rights in Europe as well.
Although the Hikma Pharmaceuticals USA name is not well known in the US, it does have a base of operations in Ohio, resulting from its 2015 acquisition of Roxane Laboratories. Hikma is also partnered with Civica Rx to supply eight essential injectable medications. Roxane, a significant manufacturer of generic agents, is active internationally.
The principal patents for this interleukin 12/23 inhibitor (reference product, Stelara®) expire in late 2023. Annual US sales of Stelara are well above the $4 billion mark. The near-term patent expiration and blockbuster revenues have sparked plenty of interest in ustekinumab biosimilars. At least six biopharmaceutical companies, including Bio-Thera Solutions, have publicly announced development programs for ustekinumab biosimilars.
Bio-Thera’s phase 1 study of BAT2206 in healthy volunteers is due to be completed this month. According to ClinicalTrials.gov, a phase 3 study in 406 patients with moderate-to-severe plaque psoriasis was to start in February and be completed in May 2023.
In other biosimilar news…The Biden Administration supports several initiatives for reducing drug costs, including allowing Medicare to negotiate directly for Part B and Part D drugs, in addition to increased incentives for doctors and hospitals to administer biosimilars. However, it will be up to a divided Congress to enact these initiatives.
The pegfilgrastim biosimilar story has widely been viewed as a qualified success. The field is a bit crowded: there are four biosimilar competitors, and more to come, in addition to the originator product Neulasta® and Neulasta Onpro® on-body injector. Amgen, the manufacturer of Neulasta, has seen ongoing, decreasing marketshare of the prefilled syringe, but it has been bolstered by the continuing dominance of OnPro. No biosimilar manufacturer has brought its own on-body injector to the market.
The on-body injector is preferred by patients and doctors, based on its convenience and reduced need for office visits. However, a study published in the September issue of the Journal of Managed Care and Specialty Pharmacy revealed that real-world economic and clinical outcomes between the two formulations were nearly identical. This may mean that any adherence benefit that may arise from the use of the on-body injector does not translate into clinical outcomes. This could provide important support for health plans and insurers that seek to prefer biosimilars over the reference formulation.
The study was funded by Sandoz, manufacturer of one of the pegfilgrastim biosimilars (Ziextenzo®). All of the biosimilars available today are available only in prefilled syringe form.
Some Difference on Costs, Little on Care
The retrospective study was conducted using a large claims database. Researchers from Sandoz and Banner University Medical Center and University of Arizona Cancer Center identified 2,170 patients with either breast cancer or non-Hodgkin lymphoma receiving myelosuppressive chemotherapy and who were prescribed pegfilgrastim to prevent febrile neutropenia over an 18-month period ending May 31, 2018. Half had used the on-body injector and half had pegfilgrastim administered via the prefilled syringe.
The mean incidence of febrile neutropenia during the first chemotherapy cycle was 1.01% for patients using the on-body injector compared with 1.48% for those using the prefilled syringe (P = .34). The difference narrowed further if all chemotherapy cycles were considered (0.91% vs. 1.22%, respectively, P = .21).
From an economic standpoint, the mean total all-cause adjusted costs between the two study groups were not statistically significant, although the prefilled syringe cohort had a slight edge ($21,745 vs. $20,655, P = .055). Patients utilizing OnPro had significantly greater outpatient costs ($14,737 vs $10,961, respectively, P < .001), although mean pharmacy costs were higher for the patients using the prefilled syringe form of pegfilgrastim ($226 vs. $319, respectively, P < .001). The researchers could not find any statistically significant associations in terms of emergency department visits or hospitalizations between the study groups. However, for 409 patients who experienced at least one hospital stay, those receiving OnPro had shorter mean hospital stays than those in the prefilled syringe groups (3.8 vs. 4.7 days, P < .001).
It should be noted that the data collection period in this study ended before the first pegfilgrastim was approved (Fulphila®, in June 2018). Therefore, this study solely compared clinical and economic outcomes associated with Neulasta and Neulasta OnPro. The introduction of biosimilars has significantly lowered the net costs of the class (including OnPro). As a result, the economic conclusions–especially regarding pharmaceutical costs–would likely be different if considered in today’s terms.
I belong to a local business group where I live in the Philadelphia metropolitan region, and I had the pleasure of speaking to them about my profession. A member of the group asked what topic I most enjoyed covering in the last few years.
I drew a breath, and reluctantly answered, “I really enjoy working in the biosimilar area.” Blank stares. Very much expected. The members of this group included lawyers, service professionals, a chiropractor, and representatives of the trades. Likely, one or two had received a biologic at some point or who had a spouse who had.
Recognizing the dilemma at hand, I offered a grain of context. I asked, “How many of you have seen Humira® or Enbrel® commercials on TV?” All raised their hand. “Those medications, injected through a syringe or given through an IV, are called biologics. These are very expensive medications. A biosimilar is basically a generic version of the biologic drug.” Blank stares dissolved into acknowledgement.
We tend to forget that education about biosimilars produced by pharma companies, the FDA, and news media rarely reach the lay public. Patient advocacy groups have a stake in biosimilar education, but they only reach patients and their families affected by a particular disorder. Biosimilars is not a topic that lights up social media.
For the vast general population, the term biosimilars doesn’t register. To them, a biosimilar drug is another brand, because that is how they will refer to the drug—not as filgrastim-sndz. On the other hand, generics are not branded. The one specific differentiating fact is that a biosimilar is a nuance of regulatory policy. Try explaining that to the person on the street, and he or she will run the other way. Without the ability to talk about regulatory differences, the public will rely on their existing knowledge for an understanding of biosimilars.
For example, the only differences between tbo-filgrastim and the originator product Neupogen® are the brand names and the minor differences in physiochemical structure that do not materially affect clinical outcomes. However, Granix® is not considered a biosimilar, because it was not approved via the 351(k) biosimilar pathway (which did not exist at the time of approval). Therefore, the public considers Granix as just another brand of filgrastim. From their point of view, what is the difference between Granix and other filgrastim products officially approved as biosimilars? The brand names.
The FDA’s most recent biosimilar decision would require even a more complicated explanation to a layperson. Semglee® (insulin glargine) was first approved under a 505(b)2 new drug application. Subsequently, the drug’s manufacturer (Mylan) decided to seek biosimilar status and more importantly interchangeable status, which was granted in late July. This is the first time a drug approved under the conventional FD&C Act was now approved under the regulatory framework of the Public Health Services Act. Try explaining that to someone outside the industry!
This does complicate the way in which we educate the general public about the availability of biosimilars. In reality, all laypeople will eventually become patients. If people ask for lower-cost options for their biologic medications, the path of least resistance is simply to inform them that other brands are available. It may well be that those brands are on a lower cost- sharing tier, or that this discussion never takes place: the biosimilars are preferred by the patients’ health plan in the first place.
Was my characterization of biosimilars as “generics for injectable pharmaceuticals” sufficient to the task? Does it provide the biosimilar education that is most helpful for the lay population? Unless the public starts asking the difficult and specific questions, as in “is this product a biosimilar?” it may have to suffice. Otherwise, I may find myself in regulatory explanations around the obscure differences between simple brands, biosimilars, interchangeable biosimilars, and their reference products.