Tony Hagen is senior managing editor for The Center for Biosimilars

Tony Hagen

Lannett, a Philadelphia-based pharmaceutical company, said it was 

 to conduct a pivotal trial—meaning critical to FDA approval—of its biosimilar insulin glargine candidate, which it hopes to launch in 2023. The company said it intends to file an investigational new drug application to the FDA later this year, which would allow it to initiate the trial early in 2022.

Glargine is a long-acting insulin. The biosimilar candidate would reference Lantus, produced by Sanofi. There are no FDA-approved insulin biosimilars on the market. Lannett is primarily a generics producer and distributor. The insulin glargine project is being handled in partnership with the HEC Group of Companies.

Lannett said it recently had a Biosimilar Biological Product Development Type 2 meeting with the FDA and followed up by submitting a protocol for the trial along with a statistical analysis plan for product development. Lannett said it has received feedback on that submission and incorporated the guidance into the pivotal trial design.

Modifications made to the trial design to comply with FDA requirements included type and size of the trial and primary and secondary end points. “The proposed pivotal trial, albeit with a larger number of proposed participants, is similar to the previously completed first human volunteer pilot study, which indicated that the Lannett/HEC insulin glargine product was biosimilar to US-approved Lantus in terms of meeting all pharmacokinetics and pharmacodynamics safety end points in the study,” Lannett said.

In February 2021, Lannett stated that it was also working with HEC to bring a short-acting insulin aspart biosimilar to market. Insulin aspart is usually taken just before meals to control blood sugar levels in adults with type 1 and type 2 diabetes. The company said that in partnering for development of this agent, it was taking aim at a $6 billion market that includes NovoLog, a Novo Nordisk product. The long-acting market is somewhat larger: $10 billion, according to IQVIA.

“We believe the clinical program for biosimilar insulin aspart will be quite similar to the clinical program for our biosimilar insulin glargine product, which is around 1 year further along in development," Tim Crew, CEO of Lannett, said in a 

Articles

Lannett modifies a pivotal trial design to ensure a smoother ride through the FDA product review.

Lannett Gears Up for Pivotal Trial of Its Insulin Glargine Candidate

Alteogen, a Daejeon, Republic of Korea biopharmaceutical developer, said it has successfully 

a phase 1 clinical trial of an aflibercept biosimilar referencing Eylea.

Investigators said the Alteogen biosimilar candidate (ALT-L9) and the originator product were randomized 1:1 to 28 patients with neovascular age-related macular degeneration in a double-blind, controlled trial. They said no adverse drug-related reactions were observed in either patient cohort and improvements in best corrected visual acuity and central subfield thickness were similar across the groups.

“In this phase 1 clinical trial, Alteogen confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea,” the company said in a statement. The company hopes to complete an accelerated phase 3 trial using the results of the phase 1 trial.

Eylea is a flagship product for Regeneron, a Tarrytown, New York–based company that garnered $4.9 billion in US aflibercept 

In the statement, Alteogen said it hopes to potentially be the first to launch an aflibercept biosimilar, although it did not specify which market. The phase 1 trial was conducted at 4 hospitals in Korea. However, the company said it has strengthened the biosimilar candidate’s potential with a formulation patent registered in the United States, European Union, and Japan.

“Alteogen is uniquely positioned based on our patent position to launch a Eylea biosimilar upon substance patent expiration,” said Soon Jae Park, CEO. “Our patent position will give us a potentially commercial first-mover advantage.”

Regeneron has stated that its US and EU composition-of-patents for aflibercept will expire in 2023 and 2025, respectively. The company also has manufacturing, formulation, and administration regimen patents that expire at later dates. Regeneron has also stated intentions to try to extend the Eylea exclusivity window by filing more patent claims. In China and Japan, the product loses patent protection in 2022, offering an earlier market opportunity for Alteogen.

. Formycon and Bioeq have teamed up on development and licensing of their own aflibercept biosimilar candidate (FYB203). They announced a phase 3 equivalence study for the biosimilar in August 2020.

Momenta, Amgen, and Coherus BioSciences, and Samsung Bioepis each have aflibercept biosimilar candidates of their own.

Alteogen is among a number of contenders vying to bring aflibercept biosimilars to market. Key patents on the originator begin to expire in 2023. 

Alteogen Completes Successful Phase 1 Aflibercept Trial

Oncology providers are, in general, highly sensitive to costs of biologics, so expanding payer coverage of these agents to include lower-cost options is likely to drive adoption of biosimilars in oncology, said Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health.

“From our surveys we know that the top 2 reasons oncologists are likely to prescribe a biosimilar are if it provides costs savings to the patient or practice or if the insurance company mandates a switch,” Oskouei said at this year's Association of Community Cancer Centers (ACCC) 47th Annual Meeting & Cancer Center Business Summit. Her presentation covered motives and biases that influence the prescribing behavior of oncologists.

A 2017 Cardinal Health survey identified fear of monetary loss as the chief bias influencing physician decision making in oncology, with 23.9% of respondents in agreement. These same physicians identified a strong bias toward following established guidelines from such nationally recognized entities as the National Comprehensive Cancer Network and the American Society of Clinical Oncology (22.0%). Lack of clinical response and the predictability of outcomes were 2 other factors that oncologists identified (16.5%) as influencing their likelihood to prescribe biosimilars.

“The responses really haven’t changed that much since 2017. This is a consistent theme when it comes to biosimilar utilization—the correlation to cost savings,” Oskouei said.

Whereas physicians may gravitate toward biosimilar use to save money, value-based care programs, such as alternative payment models (Oncology Care Model, Oncology Care First, Merit-based Incentive Payment System) are accelerating that trend, she said. “Biosimilars are really valuable tools for providers practicing in the value-based care initiative. These are ways to allow cost savings and efficiencies in delivering high-value cancer care and expanding the use of biologic treatment.”

In fact, loss aversion is a very powerful motivator in the oncology sector. Asked in 2017 how often fear of not being reimbursed influences their prescribing habits, 37.1% of oncologists answered “very often," and 25.8%, “moderately often.”

“The fear of monetary loss has double the impact of any potential equivalent gains, studies have shown, so it makes sense that this would be a primary driver of potential bias,” Oskouei said.

Familiarity with biosimilars plays a large role in acceptance and use, she said. Oncologists were first introduced to biosimilars via supportive care products, which as indirect treatments for cancer present a lower-stakes risk for oncologists. Their positive experience with these products may have contributed to their acceptance of therapeutic oncology biosimilars, she said.

However, familiarity also may mean a dependence on peer experience with and willingness to adopt biosimilars. For example, in a 2017 survey, 64% of oncologists agreed that they expected to be early adopters of biosimilars, but 33% said they would wait for other academic and community leaders to adopt biosimilars before prescribing them themselves, and the remaining 4% said they would not use biosimilars unless mandated to do so by payers.

“They’re trying to develop that familiarity and see peers utilize biosimilars and build more confidence in the outcomes before adopting,” Oskouei said.

Oncologists’ confidence in biosimilars may be biased by the statements about them written by the FDA and other authorities, she added. For example, the statement “Biosimilars are not inferior to reference products in terms of safety and efficacy” is less convincing than “Biosimilars are as safe and effective as the reference products."

Indeed, the FDA has considered rephrasing biosimilar language to get around the bias that such cautious language induces.

Differences in the language used to present biosimilar is known as “framing,” and these differences have the potential to influence decisions about the use of these agents, Oskouei said. 

“A lot of educational efforts and programs have helped address the potential framing bias with biosimilars,” which has turned up in literature from not only the FDA but also health care industry sources, she said.

When it comes to biosimilar uptake, a lot depends on physician education, but other agents and drug developments also play a role. Originator manufacturers are continuously innovating, developing new formulations of existing treatments, new methods of delivery, and also new medicinal products entirely, Oskouei said.

“We can’t just look at the originator biologic and the biosimilars in silo when making treatment decisions, because there are continued advancements and novel dosage forms that can compete with biosimilar utilization. Conversely, there’s also the discussion around obsolescence when it comes to biosimilars and their originator biologics,” she said. “The key message is that it’s really going to continue to be a very dynamic market.”

Oskouei ST. Biosimilar adoption in oncology: how attitudes have changed and what’s ahead? Presented at: ACCC 47th Annual Meeting & Cancer Center Business Summit; March 1-5, 2021. Accessed March 5, 2021. https://www.accc-cancer.org/home/attend/accc-47th-annual-meeting-cancer-center-business-summit/agenda#undefined5

Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health, discusses motivating factors that affect use of biosimilars in oncology.

Oncologists' Cost Sensitivity May Drive Biosimilar Uptake

Biosimilars have become largely integrated within oncology therapeutic and supportive regimens, and surveys of oncologists indicate these professionals are increasingly comfortable with not only using these agents but substituting them for originator biologics, according to Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health.

Biologics spending predominates over small-molecule drugs in oncology, antidiabetics, and immunology, so there is an outsized potential for biosimilar growth in those classes of drugs, Oskouei said at the Association of Community Cancer Centers (ACCC) 47th Annual Meeting & Cancer Center Business Summit, March 1-5, 2021.

Filgrastim biosimilars were introduced to the US market in September 2015 and have achieved a 90% share of the market for this agent, which is used to boost white blood cell count following chemotherapy, Oskouei said. Bevacizumab biosimilars entered the market in July 2019 and now command a 59% share of their respective market. Bevacizumab is used for treatment of ovarian, cervical, renal, non–small cell lung, and colorectal cancers, among others.

Trastuzumab, for breast, stomach, and esophageal cancers, entered the market in biosimilar form in July 2019; these biosimilars now have a 43% share of their respective market. The comparable date and market share for rituximab, for autoimmune diseases and cancer, are November 2019 and 48%, respectively, according to Oskouei.

“The vast majority of biosimilar experience in the United States is in the oncology space currently. Just in December we had a fourth pegfilgrastim biosimilar become available and in January 2021 we had a third rituximab bisosimilar” enter market, Oskouei said.

Pegfilgrastim biosimilars, with 31% market share in the United States, have achieved the lowest share among biosimilars in oncology, although this is partly attributable to the Neulasta Onpro, a reference manufacturer product that offers the convenience of home-based injections.

Surveys conducted by Cardinal Health have yielded insight into oncologists’ improving disposition toward and knowledge of biosimilars. Whereas just 30% of those surveyed in 2017 (n = 61) stated they were very familiar with biosimilars, 53% said they were very familiar with biosimilars in 2020 (n = 195).

The survey findings also suggest that providers are increasingly likely to prescribe biosimilars for their patients. Asked whether they would prescribe biosimilars for new patients, 53% answered yes in 2017 (n = 93) vs 67% in 2020 (n = 195). The same study suggested that those willing to prescribe biosimilars for patients who were successfully treated with reference biologics rose from 28% in 2017 to 70% in 2020. “We can see there’s been a big shift,” Oskouei said.

According to the 2020 survey, 86% of oncologists said they would prescribe biosimilars in indications acceptable for extrapolation, vs 57% in 2019. In 2020, just 5% said they would extrapolate only for supportive care biosimilars. Oskouei stated that was “a pretty significant jump.”

In the 2020 survey, 72% said they would feel comfortable with switching patients from one biosimilar to another for the same condition. “That, again, highlights the sense of comfort that has developed with the FDA approval process and the scientific rigor that goes behind extrapolation and approving biosimilars as highly similar to reference biologics,” Oskouei said.

For more coverage of this year's ACCC meeting, click 

Survey results show that oncologists are embracing biosimilars not just in supportive care but for therapeutic uses also. 

Cardinal Health: Oncologists’ Comfort With Biosimilars Is on the Increase

 that would broaden access to biosimilars by requiring health plans and pharmacy benefit managers (PBMs) to cover all versions of biological agents, including biosimilars. The bill is a response to payer policies that sometimes narrow choices of biosimilars and reference products and may force providers and patients to use agents that are more costly than other versions of the same biologics.

“The change would give all patients access to the most affordable and effective version of their medication without compromising safety standards,” Representative Jennifer Schultz (D, Duluth) and Senator Carla Nelson (R, Rochester) said in a statement announcing the bill (SF 990). Schultz said the draft legislation was developed in consultation with research scientists at Essentia Health and Mayo Clinic.

“Biosimilar medications are just as safe and effective as their brand counterparts,” said Eric Tichy, vice chair of Mayo Clinic Pharmacy Supply Solutions. “They are also the most powerful tool we have to control the cost of prescription drugs. Facilitating provider prescribing of biosimilar products for patients supports high-quality care and reduces delays and red tape while also managing the high costs of medication."

, PBMs and health plans would not be permitted to prefer or require the use of reference biologics, biosimilars to reference products, or biologics deemed “interchangeable” to reference biologics. If a PBM or health carrier offers coverage of a reference product or biosimilar, it must also cover all versions of that same drug, including reference and biosimilars.

Also under the bill, the Minnesota commissioner of health would be required to track the legislation’s effect on net prices for different payers of biological products, interchangeable biological products, and biosimilar products.

JD Supra, the legal news website, stated that the bill if enacted would produce the first law of this kind. The bill’s supporters have chosen January 1, 2022 as the proposed go-live date.

Minnesota legislators introduce what could possibly become the first law to curtail payers' rights to determine which biologics patients have access to.

Minnesota Moves to Override Payer Preferences on Biosimilars

A study of comparative clinical efficacy trials for biosimilars, often considered unnecessary, suggests that these trials are 

as those done for originator products, and often are more costly than for new molecular entities.

The study evaluated biosimilar trials conducted for products approved between January 2010 and October 2019. “When phase 3 efficacy trials were required (21 of 23 approved biosimilars), the median patient enrollment, treatment duration, and estimated costs often exceeded those reported in published studies of FDA pivotal trials required for new molecular entities,” authors of the study wrote.

Comparative clinical efficacy studies are designed to confirm the clinical equivalence of a biosimilar candidate to its reference product using a study population, prespecified margins, and an efficacy end point. These studies help elucidate the safety and immunogenicity, or potential to generate an immune system response, of biosimilars vs reference products.

Critics of comparative clinical efficacy studies 

that these trials are generally wasteful and do not produce data that are nearly as useful in proving biosimilar equivalence as earlier-stage pharmacokinetic and pharmacodynamic studies. One reason biosimilar sponsors continue to do comparative in-human studies is that they help to convince providers that biosimilars are equivalent to reference products because providers are more accustomed to studying comparative results for their product information.

Investigators found that the median cost of 29 comparative efficacy studies for biosimilars was $20.98 million. For 24 of these studies, the median enrollment was 538 with an average treatment duration of 55 weeks and a median cost of $27.6 million 

By comparison, the median cost for 138 pivotal trials that supported the approvals of 59 new molecular entities from 2015 to 2016 was $19 million, although investigators added a caveat. “They are not exact comparisons given that the previous findings included biologic products and small-molecule drugs and that phase 3 trials were usually but not always required for marketing approval.”

With regard to enrollment in nonbiosimilar trials leading to FDA approvals from 2005 to 2012, the median patient enrollment was 446 in phase 3 studies.

For the 29 comparative efficacy studies for biosimilars, the median treatment duration was 52 weeks. For 100% of the phase 3 biosimilar efficacy trials, the treatment duration exceeded 26 weeks. Investigators said that just 35% of the pivotal trials supporting approvals in 2015 and 2016 had treatment durations that exceeded 26 weeks.

One characteristic of these trials was that trial duration was generally extended because investigators sought to enroll patients at multiple global sites. The phase 3 studies lasted a median of 26 months from reported start to actual completion, although phase 1 studies were finished in a median of 3 months.

Investigators also looked at FDA reviews of biologics license applications (BLAs) and found that biosimilar reviews took a similar amount of time to complete—a standard 12 months—and none qualified for expedited review. They said 14 biosimilar BLAs completed without delays were reviewed in a mean time of 350 days.

A look at FDA inspections of manufacturing facilities and clinical trial sites showed that the FDA halted BLA reviews for 9 of 23 biosimilars (39%) following these on-site inspections and issued complete response letters stating that the FDA reviews could not proceed until deficiencies noted in the inspections were remedied. Common deficiencies were product quality, manufacturing process, and facility inspection failures.

According to the study, it took biosimilar sponsors from 59 days to 433 days to fix these problems and resubmit their BLAs.

The investigators noted that the global nature of the biosimilar comparative efficacy trials was a challenge for the FDA review process, often requiring on-site inspections. A mean of 12 countries were involved in the trials included in the review.

“The FDA performance and actions in reviewing biosimilar applications were timely and had analytical and inspectional depths that were similar to those seen in previous reviews of new molecular entities,” investigators wrote.

Speculating on why comparative clinical efficacy trials are larger, more costly, and longer than those for new molecular entities, investigators said that when small differences between drugs must been determines, patient enrollment numbers must be large to demonstrate statistical significance of findings. Further, a high level of confidence (CI, 90%-100%) must be established to satisfy FDA requirements for noninferiority trial designs.

Authors of the study concluded that it may be advisable to expand the size and scope of comparative clinical efficacy trials new drug candidates, “given that pivotal trials for new molecular entities provide the primary and essential new scientific evidence that will guide the treatment of thousands to millions of future patients, an ethical and policy question arises about whether numerous, larger, and more costly trials should be conducted to demonstrate that no meaningful differences exist from a proven treatment.”

Moore TJ, Mouslim MC, Blunt JL, Alexander GC, Shermock KM. Assessment of availability, clinical testing, and US Food and Drug Administration Review of Biosimilar Biologic Basics.

. 2021;181(1):52-60. doi:10.1001/jamainternmed.2020.3997

Investigators evaluated trial spending and reasons for biologics license application failures. 

Study: Biosimilar vs Originator Spending on Comparative Efficacy Trials

 for its proposed ustekinumab biosimilar (SB17), referencing Stelara. Ustekinumab is for the treatment of plaque psoriasis and psoriatic arthritis. The company said the trial is a randomized, double-blind, 3-arm, single-dose study comparing pharmacokinetics, safety, tolerability, and immunogenicity of SB17 and the originator drug in healthy men.

Investigators will enroll 201 volunteers 18 to 55 years of age and randomize them 1:1:1 to a 45 mg dose of SB17, EU-sourced Stelara, or US-sourced Stelara. Primary end points are drug exposure following administration and peak drug concentration, and secondary end points are adverse events and development of antidrug antibodies to ustekinumab.

Samsung Bioepis has 3 biosimilar candidates in phase 3 development: eculizumab (SB12, immunosuppression), aflibercept (SB15, ophthalmology), and denosumab (SB16, osteoporosis). 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for marketing authorization of a bevacizumab biosimilar candidate developed by Biocon Biologics and Viatris (formerly Mylan/Upjohn). A final decision on the drug approval application is anticipated from the European Commission in May 2021. The bevacizumab biosimilar candidate would be marketed under the brand name Abevmy in injectable doses of 100 mg and 400 mg. The product, for the treatment of cancer, references Avastin (Roche), and works by inhibiting the development of blood vessels that enable the tumor growth.

“CHMP’s decision to recommend approval of our biosimilar bevacizumab brings us a step closer to enable affordable access to this biologic therapy for cancer patients in the European Union along with our partner Viatris,” Kiran Mazumdar-Shaw, executive chair of Biocon Biologics, 

Final authorization would enable Biocon and Viatris to market the biosimilar in 27 EU member countries and in the European Economic Area, which includes Norway, Iceland, and Liechtenstein. The United Kingdom is independently regulating drugs and approvals following Brexit; however, it has a “reliance procedure” under which EU-approved drugs can be marketed in the United Kingdom shortly after they receive a CHMP nod.

Cipla, a Mumbai, India-based company, said 

 to manage the marketing and distribution of 4 Alvotech biosimilars in Australia and New Zealand. Alvotech is an Icelandic company with numerous biosimilars in development and a strategy to market them globally via multiple business partners once regulatory approvals are granted.

Cipla said a subsidiary, Cipla Gulf, would directly manage the sales and distribution under this agreement. The biosimilar candidates are aflibercept (ophthalmology), ustekinumab, denosumab (osteoporosis), and golimumab (rheumatoid arthritis), referencing Eylea, Stelara, Prolia/Xgeva, and Simponi, respectively.

 (2019) to market an Alvotech adalimumab biosimilar (AVT02) in emerging markets. AVT02 references the rheumatology and gastrointestinal treatment adalimumab (Humira).

Biocon and Viatris edge closer to EU marketing authorization for a bevacizumab biosimilar, among other biosimilar business developments.

News Briefs: Samsung Bioepis, Cipla, Biocon Report Progress

for the use of biosimilars from the National Comprehensive Cancer Network (NCCN) addresses challenges of stocking biosimilars, dealing with procurement errors, and obtaining payer authorizations.

It also advises health care providers to lobby for more liberal payer policies, stating that current payer preferences threaten the long-term existence of biosimilars. “We strongly recommend against single-source mandates of biosimilar products by insurance companies for a variety of patient safety and operational reasons,” the NCCN wrote. 

Human error during the biosimilar procurement process is another challenge for practices, and the NCCN paper identified numerous other potential breakdowns and their effects on clinical efficiency 

The NCCN said its recommendations provide for the safe and efficient use of biosimilars in the clinical setting. The guidelines were built around findings from a survey issued by a task force within the NCCN’s Pharmacy Directors Forum, which began working on the project in 2019.

“There are significant challenges from an operational standpoint and unique risks that exist when using these products in the care of patients,” even though they have the potential to reduce the costs of health care, the NCCN said.

Risks of using biosimilars include medication errors, financial toxicity for patients, and economic difficulties for health care institutions and providers. “Payer policies, such as single sourcing coverage of biosimilar medications, can be a root cause of some of these risks,” the group said.

The lower costs that biosimilars offer—approaching 50% in some cases—are enticing. “However, there are several important observations that must be considered which make biosimilar products less than the universal panacea they were hypothesized during their inception,” the NCCN guideline said.

Payers have a large role in the choice of biosimilars, and this was the top-rated concern among those who took the survey. Making the electronic health record work to identify coverage for biosimilars was the second highest-rated concern, followed by the challenges of obtaining payer authorization for biosimilars. Actual procurement of biosimilars and effective storage of multiple biologics also were high-ranking concerns.

“One strategy is to stock multiple biosimilar products…. However, this strategy may increase carrying costs and place a strain on storage requirements such as refrigerators,” the NCCN said. Dispensing errors may increase if staffers grab the wrong product off the shelves.

Payers may prefer one biosimilar over others potentially because they have a contract with the manufacturer rather than because it’s the best option for the health care institution or patient, the NCCN said.

“The payer will specify a particular biosimilar product as being the preferred product and that other biosimilars are therefore ‘not medically necessary’ or ‘do not meet medical necessity requirements’ unless or until the patient has received and is unable to tolerate the ‘preferred’ biosimilar product,” the NCCN said.

These payer preferences threaten the continued availability of biosimilars and add an element of complexity that can lead to costly errors for the practice that must follow different policies for multiple payers. “Such challenges are based solely on insurance company restrictions, which are generally not visible to the physician or pharmacist, and often are not known ahead of time by the finance department,” NCCN said.

The NCCN said such practices run counter to Congress’ intent when it established the biosimilars approval pathway to promote the development of lower-cost biologics. The NCCN recommended that health care providers “reach out to legislators, government agencies, employers and patients to help advocate against payer’s practices of allowing for reimbursement of only one biosimilar product.”

In the meantime, one coping strategy would be to carefully coordinate in-house activities at health care institutions, such as having pharmacy departments work closely with precertification departments and revenue cycle teams, the recommendations said.

The National Comprehensive Cancer Network (NCCN) recommended providers contact their legislators to counteract single-biosimilar payer policies. 

NCCN Issues Guidelines for Biosimilar Use

Coherus BioSciences said its pegfilgrastim biosimilar Udenyca now commands a 21% share of the overall US market for this agent and a “nearly 50%” share of the prefilled syringe segment. Company executives said they hope to begin chipping away at the market for Amgen’s Neulasta Onpro, a wearable pegfilgrastim injector kit, if the pandemic eases and conditions return to normal.

 Udenyca sales of $476 million for 2020 vs $359 million for 2019. In addition, Udenyca sales for the fourth quarter of 2020 were $110 million, down from $124 million in the comparable 2019 quarter. Coherus attributed the decline to COVID-19–related issues and anticipated that full-year 2021 Udenyca sales would be lower than in 2020, also because of COVID-19.

“Certainly, COVID-19 made 2020 a difficult year for Udenyca, impacting our ability to grow market share as planned in the face of new competitive entrants,” Dennis M. Lanfear, president and CEO, said during an earnings 

The bottom line, said Chris Thompson, executive vice president of sales, is that Coherus must hold the line on average sales price 

for Udenyca to maintain a robust profit margin, although some price decline is anticipated. "The most challenging variable for us to forecast and the one over which we have the least control is, of course, price. That said, our goal is to remain disciplined, as we have been, in our long-term management of ASP while also remaining competitive. We would expect our competitors to operate in this rational manner as well."

The company is anticipating upward growth in Udenyca sales to resume in the second quarter of 2021, as conditions return to normal and the COVID-19 advantage starts to fade for Onpro, which has enabled patients to receive pegfilgrastim injections at home, sparing them the risk of infection from a trip to the clinic—although the injector kit is less reliable that clinic injections. “We expect that, as COVID-19 recedes, we will resume market share growth, largely coming at the expense of the Neulasta Onpro,” Lanfear said.

Lanfear also discussed pipeline projects to bring other biosimilars to market. He noted that the FDA has accepted the company’s biologics license application (BLA) for an adalimumab biosimilar (CHS-1420), referencing Humira and indicated for rheumatologic and gastrointestinal disorders. The FDA has set a December 2021 decision date for the BLA.

“After years of double-digit price increases with Humira, there is clearly significant pent-up demand” for a lower-cost biosimilar. There are multiple approved adalimumab biosimilars, but none of these will be available before 2023. Recently, Vizient predicted a 7.5% increase in the price of Humira before biosimilars do reach the market.

“There will be a payer-driven dynamic, and they are heavily incentivized, too, for switching from the brand to biosimilars,” Lanfear said. He added Coherus aims to achieve a 10% share of the US market for adalimumab.

Coherus is partnering with Bioeq on development of a ranibizumab biosimilar, referencing Lucentis. The drug is used for the treatment of macular degeneration. A 2021 midyear FDA application submission is planned.

The company also has a bevacizumab biosimilar in development (IBI-305), referencing Avastin and indicated for the treatment of various types of cancer. This project is in conjunction with Innovent. A pharmacokinetics study is underway.

Additionally, company executives expressed optimism for a recently announced partnership with Junshi Biosciences of Shanghai, China, to commercialize toripalimab, an anticancer PD-1 antibody, in the United States and Canada. Toripalimab is indicated for second-line treatment of unresectable or metastatic melanoma in China. Coherus 

 to commercialize this product and obtain options to market 2 potential other agents in the United States and Canada.

Sales of the pegfilgrastim oncology support biosimilar Udenyca fell off in late 2020, but Coherus doesn't see orginator company Amgen's advantage lasting much longer. 

Coherus BioSciences Squares Off Against Neulasta Onpro

Fresenius Kabi, a Bad Homburg, Germany-based biopharmaceutical company with global operations, mapped out an ambitious biosimilar launch program as it released 

data that showed a 4% decline in net income ($2.2 billion) and 2% growth in sales ($44.0 billion) for 2020.

The company expressed confidence in its potential to make biosimilars an exceptional driver of income in the near future, although company executives described “unprecedented challenges” over the past year of the coronavirus disease 2019 (COVID-19) pandemic that affected performance.

“I am convinced these times will reward corporates who can draw resilience from their large critical infrastructure and well-proven business models,” said Stephan Sturm, CEO, in an investor presentation.

Fresenius has an adalimumab biosimilar that has been launched in 22 countries, most recently 

. In the second quarter of 2021, the product will be launched in Australia; and in the third quarter, Brazil. A US launch is planned in 2023.

The company said its biologics license application for a pegfilgrastim biosimilar was accepted by the FDA and European Medicines Association in May 2020. In those markets, the product is intended to launch in a prefilled syringe in the third quarter of 2021. In 2022, Fresenius hopes to launch a pegfilgrastim on-body injector, a device that has enabled the originator company, Amgen, to capture significant 

“Even though the prefilled syringe launch is important, the planned on-body device market entry is financially significantly more meaningful for us,” Sturm said.

The company has previously announced plans to bring a tocilizumab biosimilar to market, and the anticipated launch date is 2023 in the US and EU markets for subcutaneous and intravenous versions of this. The tocilizumab biosimilar would reference Actemra, for the treatment of rheumatoid arthritis. “The financially more meaningful market for us is the subcutaneous dosage form, since we are currently assuming to lead the competition here,” Sturm said.

Autoimmune biosimilars and an oncology biosimilar are slated for launch in 2024 and 2025, respectively, in the US and EU markets, although further description was not provided in the investor presentation.

Whereas biosimilars are an increasingly important part of Fresenius’ growth strategy, the company has a broad portfolio of therapeutic products in oncology, diabetes, critical care, liver and renal insufficiency, among others.

The Germany-based company with global operations plans to ramp up its biosimilars portfolio through 2025. 