Tony Hagen is senior managing editor for The Center for Biosimilars

Tony Hagen

The European Commission (EC), the group that authorizes medicines for the European Union, has issued a 

for emerging from the coronavirus disease 2019 (COVID-19) pandemic with a stronger, more competitive health care industry that is more supportive of the uptake of biosimilars and generics.

The EC “pharmastrategy” issued this week outlines a myriad of goals, such as achieving a more competitive system that does not discourage innovation or turn biosimilar and generic producers away, developing a deeper understanding of pharmaceutical supply chain issues so that uncertainties spawned by the pandemic can be managed more effectively the next time, and improving country-by-country procurement of medicines by strengthening the competitive bidding system.

“Though we are experiencing a period of rapid change and innovation, many patients do not benefit from that innovation, because medicines are either unaffordable or unavailable. And there is greater awareness of the need to ensure that our use of pharmaceuticals is sustainable,” the EC said.

The blueprint also calls for stepping up efforts to develop new antimicrobials and antibiotics (a subclass of antimicrobials) and impose regulations that encourage more safe and sensible use of these medicines. This will include greater use of existing regulatory tools to combat growing resistance to these medicines.

In response to the statement, Medicines for Europe, a trade association of pharmaceutical manufacturers, called upon the EC to work especially hard to develop a marketplace that promotes access to biosimilars, generics, and other “value-added” drugs.

“Often in Europe, patients can only fully access the medicines they need when the off-patent version becomes available. Barriers to off-patent medicines use must be removed,” the group said in a 

COVID-19 has had “a very serious impact on Europe,” and although the European Union’s strengths in responding have been showcased during the pandemic, its vulnerabilities have been “thrown into sharp focus,” the EC said. There have been problems with data availability, medicine supply, and manufacturing capacity.

“The conclusion of advance purchase agreements for vaccines is nevertheless an example of effective cooperation between public and regulatory authorities, industry, and civil society organizations,” the EC said.

But because of access bottlenecks in various markets, innovative therapies do not always reach patients, the EC said. “Companies are not obliged to market a medicine in all EU countries.” 

This might happen because of national pricing and payment policy, population size, health system organization, or relative wealth factors country by country, the EC suggested. The blueprint included recognition of a critical lack of transparency on research costs and necessary return on investment, which each factor into a company's decision to enter or refrain from entering a market.  

“Drawing on this and wider experience, the commission will review the system of incentives,” the EC said.

In tandem with this, the EC said it will consider “targeted policies” for beefing up generic and biosimilar competition. “This may include further clarifying the provisions for the conduct of trials on patented products to support generic and biosimilar marketing authorization applications.”

The EC said it intends to buttress these efforts with “enforcement” of rules on competition, noting that “originator companies sometimes implement strategies to hinder the entry or expansion of the more affordable medicines of their generic and biosimilar competitors and that such strategies may require competition law scrutiny.”

Reforming the competitive landscape is not a one-way street, the EC said. It called upon health systems and private companies to make use of an “innovation partnership” tender system that allows for cooperative agreements on development, manufacturing, and subsequent purchase of medicines.

“Certain conditions…such as the absence of automatic substitution rules for biologicals, can create market barriers,” the EC said. “This lack of competition thus inhibits price savings once innovative products lose their market exclusivities. The commission will take this into account in the review of the pharmaceutical legislation, to see how sound competition can best be fostered, leading to a downward effect on prices of medicines.”

In a recent white paper, Medicines for Europe described numerous intellectual property hurdles that constitute barriers to entry for biosimilars and generics. To read the story, click 

Articles

The European Commission (EC) said it will take the lessons learned from the coronavirus disease 2019 (COVID-19) pandemic and build a better marketplace for generics and biosimilars.

EC Eyes Enhancements for a Post–COVID-19 Marketplace

With the pandemic raging, things are done differently in the biosimilars sphere these days, Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in an interview at the Financial Times Global Pharmaceutical and Biotechnology Conference 2020.

For one, regulators seem motivated to move applications along swiftly, he said. “Regulators are acting much faster than they ever have. I’ve never seen clinical trials being approved this quickly. And their willingness to engage and look at the interim results…has been welcoming sight. I hope that regulators will continue this type of approach post-pandemic. Then we’ll see a much greater number of products being approved in a short period of time.”

On the other hand, the pressure is on to make supply chains watertight. This has meant building in redundant systems to ensure that if there’s a breakdown in process or supply flow, the goods can get to market, he said.

“The pandemic taught us that we need to be better prepared as a company and as an industry. Redundancies have been built into vendor selection, raw material production, and shipping methods.

“Prior to the pandemic, it was taken for granted that this much duplication was unnecessary, but we realized that we needed to become experts at those details and be vigilant about it,” Ko said. It was also necessary to become more involved with suppliers to understand their operations and COVID-19 precautions “to make sure that they had enough staffing and that people were being trained as backup.”

This also goes for ensuring the success of clinical trials, he said. Those who sponsor and run clinical trials want to be sure that sufficient quantities of experimental drugs are going to be available.

“It’s still very difficult with current restrictions and with the second wave that’s hitting Europe and the United States,” he said. “These are sort of the last hopes for the sick patients—to be on clinical trials to get affordable care. We have to constantly communicate to investigators, nurses, and patients to give them the assurance that the investigational product will be delivered so they can plan ahead.”

Samsung Bioepis is an Incheon, Republic of Korea–based joint venture between Samsung Biologics and Biogen. Predominantly a biosimilars company, Samsung Bioepis has 5 drug products launched in Europe and 2 in the United States.

Biosimilars represent a means of expanding access to medicines during coronavirus disease 2019 (COVID-19) because as they are introduced, they enable health care institutions to save money and use these savings to expand other types of care, Ko said.

“All countries globally are concerned about the rising health care cost. There’s a limited amount of money they can spend on health care, but innovations have to happen, and there’s built-up pressure that can no longer accommodate new innovation, which makes biosimilars the pressure valve,” he said.

And the savings can be enormous, Ko said. This is partly because modern biologic manufacturing processes have evolved and even current systems of producing biosimilars may be far more efficient than ones originally used for creating the reference drugs.

“We’re using state-of-the-art, cutting-edge technology with process innovations. We’re able to deliver our products at much lower costs. In some territories, we’ve seen biosimilar prices discounted 80% to the originator.” The savings potential is significant, he said.

Despite all the precautions to ensure production continuity during the pandemic, the resurgence of this virus across the globe is reason for concern, Ko said. “The number of patients diagnosed is far greater than in the first wave, earlier in 2020. I’m concerned about people’s movement and people’s inability to go to the doctor’s office and get new prescriptions filled and receive a diagnosis,” he said.

Also, pandemic limitations on movement are reshaping product development, Ko said. “Traditionally, all oncology products were infused, so this required infusion chairs at clinics, and those are becoming a much more costly option for health care systems. Now, they’re trying to use subcutaneous formulations that patients can administer at home. We will continue to see the migration from an infusion setting to a self-care type of subcutaneous, auto-injectable space or some other format that allows a patient to administer outside the clinic,” he said.

Christopher Hansung Ko, PhD, president and CEO of biosimilars company Samsung Bioepis, discusses innovations and precautions the pandemic has brought to the field of biosimilars.

Samsung Bioepis CEO Discusses the Pandemic's Effect on Biosimilars

Bio-Thera Solutions of Guangzhou, China, has filed a marketing authorization application to the European Medicines Agency for approval of BAT1706, an investigational biosimilar candidate that references Avastin. 

The company said it hopes to obtain authorization for all indications of the reference product in the European Union, Iceland, Norway, and Leichtenstein. 

The application marks the first "ex-China" application for biosimilar approval, or approval application for a drug developed in China for marketing abroad. 

"Bio-Thera intends to bring its pipeline of biosimilars and innovative therapies to patients around the world and this submission is an important step for extending the global reach of BAT1706," said Shengfeng Li, founder and CEO.

Bevacizumab targets vascular endothelial growth factor (VEGF) by blocking the binding of VEGF to its receptor and thereby reducing vascularization that supports the development of tumors. 

The reference product is approved in Europe for colon and rectum cancer; metastatic breast cancer; non–small cell lung cancer; renal cell caner; epithelial ovarian, fallopian tube, and primary peritoneal cancer; and cervical cancer. 

Bio-Thera also intends to seek regulatory approval in the United States, and a biologics license application filing is anticipated before the end of 2020, the company said. 

The company has one already marketed biosimilar, Qletli, an adalimumab biosimilar, which has been authorized for distribution in China.

This marks the first time a Chinese company has filed application for marketing of a biosimilar outside of China. Bio-Thera of Guangzhou, China, said a US application is pending.

Bio-Thera Solutions Files for EU Bevacizumab Approval

Considering Alvotech doesn't have any biosimilars approved, some may question why the company is signing biosimilar distribution deals all over the globe. The answer, according to Joseph E. McClellan, PhD, MBA, Alvotech's chief scientific officer, is that the Reykjavik, Iceland-based company aims to obtain regulatory approvals for multiple products almost simultaneously in multiple countries and then launch.

The worldwide market for biologic originator drugs exceeds $300 billion and is growing at a 10% clip each year. “We’re in the earlier stages of a long-term expansion for the global biosimilars market,” he said in a recent presentation on the company’s expansion strategy and the challenges of entering markets with different regulatory standards for biosimilar approval.

On November 24, 2020, Alvotech announced a 

 with CCHT Biopharmaceutical of Changchun, China, and Yangtze River Pharmaceutical Group, of Taizhou, China, to commercialize 8 biosimilars in China. The deal follows on the heels of other announced partnerships for distribution in North America, South America, Europe, the South Pacific, Africa, and the Middle East. Alvotech has biosimilars in development for autoimmune diseases, ophthalmology, and oncology.

Regulatory standards differ from country to country. While regulators in Europe and the United States tend to hold that comparative clinical efficacy trials are not of significant value in demonstrating biosimilarity, this is not the case elsewhere, where animal and in-human studies of biosimilars may be required to complete the package of evidence required for consideration of approval.

Analytical, pharmacokinetic (PK) studies are the foundation of biosimilar approvals in the United States, but when it comes to clinical studies—although they already were performed for originator drugs—the goal for some regulatory authorities may be an added level of reassurance, McClellan said.

“In vitro tests for looking at function are much more sensitive, and as you progress from binding assays and cell binding assays, and function cell assays, your sensitivity decreases for demonstrating similarity," he said. "Of course, as you move into in vivo animal models and human clinical trials, the clinical relevance is deemed to be more significant. It’s that balance. If you’re going to do an in vivo animal model, what are you trying to solve there. It’s likely it’s about providing the confidence about the safety of the molecule."

China tends to require animal studies as a condition of doing human clinical studies, as well as the use of locally sourced reference product for the comparator drugs. It would be easier if the reference product required for testing could be standardized across the globe, McClelland said. “How do you include China when you want to use 1 product for your clinical studies, whether PK or a comparative patient study? It’s an interesting challenge.”

Such requirements also make it difficult for Alvotech to execute on another of its strategic goals, which is to perform PK similarity and clinical confirmatory studies almost in parallel to one another to speed up development and get to regulatory approval faster. With regional partnerships across the globe, “We also have that commitment to ensure that we can develop our biosimilars in a speedy manner,” McClellan said.

China is very strict about requiring that nonclinical studies be performed before clinical studies, he added.

Smoothing out the obstacles in this quest means that Alvotech has to engage with regulatory authorities from individual countries early in the development process to shape the biosimilar development project and understand local priorities for approval, McClellan said.

Japan, also one of the world’s largest markets for biologics, presents a different challenge. That country’s regulatory authority requires that subjects of Japanese origin be included in clinical studies.

Another Alvotech goal is to develop commercial scale operations for its product development efforts. The company seeks to develop biosimilars for approvals in all indications of the reference products in the markets it enters.

At its headquarters in Reykjavik, Alvotech has a 140,000-square-foot facility for manufacturing and product development. It also has a production center under construction in Changchun that will have the capacity for producing 2.5 million “patient treatments” a year. The project is a partnership with the Changchun High & New Technology Industry Group.

The company has research and development operations in Julich and Hanover, Germany; Virginia; and Zurich, Switzerland.

Joseph E. McClellan, PhD, MBA, discussed navigation of regulatory hurdles as the company continues its quest to line up distribution partnership deals across the globe. 

Alvotech Scientific Officer Describes Company's Global Biosimilars Strategy

Investigators at the Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine hope to reproduce results of a successful phase 2B trial of GP2 peptide/G-CSF in patients with HER2-equivocal or -positive breast cancer who have received a standard course of trastuzumab, reference or biosimilar form, following surgery.

GP2 plus GM-CSF is believed to stimulate a tumor-specific cytotoxic immune system response against HER2-positive cancer cells. Phase 2 studies help determine whether a drug shows any activity against the target disease and assist with setting optimal dosing. Phase 3 trials assess the value of a drug in a clinical setting.

In the retrospective, placebo-controlled phase 2B trial, completed in 2018, after a median 5 years of follow-up, no cancer recurrences were observed in the adjuvant setting among patients with HER2-equivocal or -positive breast cancer who received the full course of 6 primary intradermal injections over the initial 6 months (

 = .0338), according to subgroup analysis.

In that earlier study, the immune response, as measured by local skin tests and immunological assays, was potent, investigators said. In addition, among 138 patients who have received GP2 over 4 clinical trials, the treatment was well tolerated, with no serious adverse events attributable to the therapy, investigators said.

In the phase 3 trial, investigators hope to reproduce those results in preventing recurrence of HER2-equivocal or -positive breast cancer both post surgery and following an initial year of treatment with trastuzumab, including biosimilars.

GP2 is an investigational drug being developed by Greenwich LifeSciences of Stafford, Texas. Lead investigator and Greenwich LifeSciences CEO Snehal Patel pointed to the value of GP2 if it proves to be a reliable tool in reducing HER2-positive breast cancer recurrence. “We are addressing a potential market of up to $5 billion in a disease that affects 1 in 8 women, who if recur, will likely face metastatic breast cancer,” he said.

Patel SS, McWilliams DB, Fischette CT, et al. A prospective, randomized, multicenter, double-blinded, placebo-controlled phase III trial of the HER2/neupeptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer. Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-11, 2020. Abstract OT-13-03. https://www.sabcs.org/Portals/SABCS2016/2020%20SABCS/Final%20PDF%20Docs%20111620_All%20PDF%20File%20No%20Embargoed%20Abstracts.pdf?ver=2020-11-17-095626-250

GP2 peptide/G-CSF in HER2-equivocal and -positive breast cancer has shown promise.

Investigators Look to Cut Breast Cancer Recurrence With Posttrastuzumab Therapy

Bevacizumab biosimilar (Byvasda) in combination with the PD-1 inhibitor sintilimab injection (Tyvyt) has demonstrated significantly 

overall survival (OS) vs sorafenib (Nexavar) as frontline therapy in a phase 3 trial of patients with advanced unresectable hepatocellular carcinoma (HCC).

Based on the success of the randomized, open-label, multicenter ORIENT-32 trial (N = 571), Suzhou, China–based Innovent Biologics said it intends to apply to China’s National Medical Products Administration for approval of the drug combination.

“We look forward to this potentially becoming a new treatment regimen that could help more patients with HCC to live longer without their disease worsening,” said Hui Zhou, MD, vice president and head of Oncology Strategy and Medical Sciences for Innovent.

Byvasda is a recombinant humanized anti–vascular endothelial growth factor monoclonal antibody developed by Innovent and 

by the NMPA in June 2020. Tyvyt was codeveloped by Innovent and Lilly.

Interim findings also showed significantly improved progression-free survival (PFS) for the biosimilar combination. Findings from ORIENT-32 were presented at the European Society of Medical Oncology ASIA Virtual Congress 2020.

Compared with sorafenib, sintilimab injection with bevacizumab biosimilar demonstrated a 43.1% decreased risk of all-cause mortality (HR, 0.569; 95% CI, 0.431-0.751; 

 < .0001). Median OS was not reached in the combination arm vs 10.4 months for the sorafenib cohort, according to the independent data monitoring committee analysis.

Investigators said the combination therapy also showed a 43.5% decreased risk of progression (HR, 0.565; 95% CI, 0.455-0.701; 

 < .0001) by independent radiographic review committee analysis. Median PFS was 4.6 months in the combination arm vs 2.8 months in the sorafenib arm.

Investigators said the benefits of the combination therapy were consistent across all subgroups with no new safety signals. “With these results, Tyvyt plus Byvasda could potentially provide a new option for the first-line treatment of patients with advanced HCC,” investigators said.

“HCC is the fourth most common malignancy with the second highest mortality rate. More than half of new and fatal cases of HCC in the world occur in China every year,” said Zhou. “We are very pleased to see that the ORIENT-32 study demonstrated significant prolongation of OS and PFS in advanced HCC patients in China.”

Bevacizuamb biosimilar in combination with sintilimab delivered significantly improved overall survival vs sorafenib. 

Innovent Biologics Biosimilar Combination Surpasses Sorafenib in ORIENT-32

The Biosimilars Forum, a group formulated by major biosimilars companies to promote the use of biosimilars, has 

 Meaghan Rose Smith as its first executive director; she takes over at a time when soaring costs of biopharmaceuticals are under particular scrutiny and biosimilars face tough legal obstacles to gaining market traction.

Smith has Democratic connections and could be instrumental with the group’s efforts to promote biosimilars during the Biden administration. She was previously senior advisor and director of communications for HHS during the time the Obama administration worked on the Affordable Care Act (ACA), and previously she worked for Senator Brian Schatz, D-Hawaii, who currently sits on the Senate Committee on Appropriations.

“This is a critical time for the industry, and her extensive health care policy experience in both the private and public sector will be invaluable as we work to realize the significant cost-savings potential of biosimilars and face potential challenges to the BPCIA [Biologics Price Competition and Innovation Act],” said Juliana Reed, president of the Biosimilars Forum and vice president and global corporate affairs lead for Immunology, Inflammation, and Biosimilars at Pfizer. 

The BPCIA, the pathway for biosimilar FDA approval, is a subsection of the ACA, which is under review for constitutional acceptability by the Supreme Court. Although a negative ruling striking down the ACA 

, it remains an outside possibility, according to legal experts.

“Biosimilars are key to lowering health care costs and can save the United States billions of dollars” said Smith. “Now more than ever, as we’re dealing with the devastating impact of the coronavirus pandemic and the Supreme Court considers the BPCIA with the ACA, the future of biosimilars is critical for patients and our country.”

Most recently, Smith headed health care strategies and coalition-building efforts at the public affairs firm SKDKnickerbocker in Washington, DC.

The Biosimilars Forum includes Biogen, Boehringer Ingelheim, Coherus BioSciences, Fresenius Kabi SwissBioSim, Merck and Co, Pfizer, Samsung Bioepis, Sandoz, and Teva.

Meaghan Rose Smith's appointment comes during a time of challenges for the biologics industry.

Biosimilars Forum Chooses Director With Democratic Influence

The European Commission (EC) has approved a Pfizer biosimilar for pegfilgrastim (Nyvepria), paving the way for marketing to begin. The drug is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients who have received chemotherapy treatment. The company said marketing is expected to begin in the first quarter of 2021. 

The addition of Nyvepria will make 8 biosimilar pegfilgrastims available in the EU market vs 4 in the United States. Nyvepria received 

 for marketing in June of 2020. Febrile neutropenia is a common adverse event associated with cancer treatments and leaves patients vulnerable to infections, Pfizer explained in a statement about the EC approval.

“The development of febrile neutropenia in people living with cancer who are undergoing chemotherapy can be a very serious complication,” said Paul Cornes, MD, an oncologist and member of the continuing medical education program of the European Association of Hospital Pharmacists and core lecturer for the European School of Oncology. “The EC approval of Nyvepria provides clinicians with an alternative long-acting option that can help prevent infections.”

Pfizer said Nyvepria, the company’s sixth approved oncology biosimilar and third approved supportive care biosimilar in Europe, was approved following submission of comprehensive data package and on the basis of “totality of evidence” that demonstrated equivalence to the reference drug pegfilgrastim.

The reference product for pegfilgrastim is Amgen’s Neulasta, and this was separately approved by the FDA and the EC in 2002. Pegfilgrastim biosimilars began to appear on the European market in 2018, and there is now a crowded market for these products—in addition to Nyvepria, there are 7 pegfilgrastim biosimilars available for sale in Europe: Fulphila (2018, Mylan), Pelgraz (2018, Accord Healthcare), Pelmeg (2018, Cinfa Biotech), Udenyca (2018, Coherus), Ziextenzo (2018, Sandoz), Grasustek (2019, Juta Pharma), and Pegfilgrastim Multipharma (2019, Multipharma Biologics).

 early this year described pegfilgrastim biosimilars as having achieved a 42% market share in Europe vs 29% in the United States, where Neulasta competes alongside Ziextenzo, Udenyca, Fulphia, and Nyvepria.

However, Amgen’s patented Neulasta Onpro wearable injector device for Neulasta has taken an increasing share of the market from biosimilar versions, which must be administered inside the clinic; and providers and industry observers say the convenience of Onpro for treatment of patients during the pandemic, when office visits have declined, has contributed to the growing use of this product. Neulasta Onpro had a 

 of the US market for pegfilgrastim during the third quarter of 2020. Onpro was 

Pfizer aims to begin marketing Nyvepria in the European Union in the first quarter of 2021.

European Commission Approves Pfizer's Pegfilgrastim Biosimilar

 name suffixes are intended to aid in tracking these medicines and improve ability among health care providers to distinguish between these and other medicines; however, a study indicates that providers and health care administrators may struggle to find utility in these 4-letter appellations.

Biosimilar suffixes take the form of random jumbles of letters—deliberately devoid of meaning—such as “awwb,” which is tacked onto the end of the Amgen version of bevacizumab (bevacizumab-awwb, Mvasi). In a study presented at the American College of Rheumatology (ACR) Convergence 2020, investigators set out to evaluate how much providers and administrators know about biosimilars and whether they perceive the 

 as adding utility and reliability to the prescribing process.

Investigators said they found great variation in how well those surveyed understood basic concepts about biosimilars and a lack of appreciation for the suffix naming convention. “These survey findings suggest a knowledge gap with regard to biosimilars and lack of consensus about the usefulness of employing the 4-letter character suffix in clinical practice,” the authors wrote.

The survey included 83 prescribers and health care administrators such as pharmacists, nurses, and medical coders, an 18% response rate. Surveys were sent to individuals at the University of Pennsylvania Health System and the Corporal Michael J. Crescenz Veterans Affairs Medical Center, both in the Philadelphia area. Providers received a survey if they had previously prescribed a biosimilar.

Investigators said the general knowledge of biosimilars was “rather poor.” Just 52% (28) of respondents were able to answer correctly whether a biosimilar differed from a generic medicine (it does). And although suffixes are intended to help improve pharmacovigilance, 67% of respondents indicated that they used the brand name of the biosimilar in clinical practice to distinguish between biosimilars and their reference products. “Only a minority of respondents [27%] reported regular use of the 4-letter suffix to identify biologic therapies,” the authors wrote.

According to the findings, 85% overall said they find it easier to remember the brand name of a biosimilar than its nonproprietary name and suffix.

Among prescribers, 77% (51) answered correctly that a biosimilar has comparable efficacy, safety, and immunogenicity compared with an originator product. Among administrators, 94% (16) got the question right.

The survey results indicated 42% (28) of providers answered correctly that biosimilars are not generics, vs 88% (15) of administrators. And when it comes to knowing that, by regulatory standard, biosimilars must have the same (“exact”) amino acid sequence as the originator product, 32% (21) and 29% (5) of prescribers and administrators, respectively, answered correctly.

Investigators said 52% (34) of prescribers and 53% (9) of administrators answered correctly that there is variation between manufactured product batches whether they are originators or biosimilars.

“We hypothesize that lack of overall familiarity with biosimilars may have contributed to less comfort with the naming convention,” investigators wrote.

According to the survey, 32% of providers said they feel that the use of brand names for biosimilars introduces commercial bias in clinical decisions. And 21% of providers said the 4-letter suffix induces patients to believe there are “important differences” between biosimilars and originator products. Investigators said 32% of prescribers and 57% of administrators responded that suffixes cause inefficiencies because they conflict with other naming systems.

Of responders who said they were “still in training,” 27 (93%) were residents or fellows.

by Nancy Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs, examines some of the issues behind biosimilar suffixes.

Lavery C, Olave M, Leonard C, et al. Knowledge of biosimilars and perceptions of biosimilar naming conventions in clinical practice. Presented at: ACR Convergence 2020; November 5-9, 2020. Abstract 1605.

The FDA naming convention and its utility are not well understood, and “poor” biosimilar knowledge may be partly to blame, investigators report.

Survey: Providers, Admins Struggle to Appreciate Biosimilar Suffixes

Alvotech of Reykjavik, Iceland, said its adalimumab biosimilar candidate (AVT02) has been 

 for regulatory review by the FDA and the European Medicines Agency (EMA).

The drug references AbbVie’s top-selling Humira for the treatment of arthritis, psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis. The product candidate submitted for review is a high-concentration, 100-mg/mL dose form that matches the newest formulation of Humira, Alvotech said.

An FDA decision on the biologics license application is expected in September 2021, while the EMA decision whether to issue marketing authorization for AVT02 is anticipated in the fourth quarter of 2021, Alvotech said.

“The filings were based on the results of a comprehensive development program and data package comprising of a totality of evidence demonstrating a high degree of similarity of AVT02 compared to its reference product,” said Joseph E. McClellan, PhD, MBA, company chief scientific officer.

The pharmacokinetic (PK) study AVT02-GL-101 successfully established PK similarity between AVT02 and the reference product following subcutaneous administration of a single dose of 40 mg in healthy individuals, Alvotech said.

A second, comparative clinical efficacy and safety trial demonstrated therapeutic equivalence in patients with severe chronic psoriasis. Alvotech said safety, efficacy, tolerability, and immunogenicity profiles were similar.

“The comprehensive AVT02 development program has demonstrated key results comparatively to the reference product, and we are extremely happy to have met our primary objectives in regard to efficacy, safety, and PK similarities,” said Kimber Poffenberger, PhD, senior vice president and global head of Regulatory Affairs for Alvotech.

For recent news about Alvotech’s commercialization partnerships for the global marketing of its biosimilar candidates, click 

The rheumatology and gastroenterology biosimilar candidate would enter the lucrative market established by Humira.