Gianna Melillo

In its newly released earnings report for Q4 and fiscal year 2021, Coherus announced Udenyca—one of 4 pegfilgrastim biosimilars on the US market—delivered net sales of $73 million and $327 million, respectively.

But totals were down from those reported in 2020, with Udenyca earning a net $110.4 million in Q4 of 2020 and $475.8 million throughout the year. Decreases were mainly due to a reduction in the number of units sold and a decline in net realized price resulting from increased competition and COVID-19 impacts, the company said in a 

Udenyca is a colony stimulating factor that promotes white blood cell growth and is used to treat neutropenia resulting from cancer medications.

Coherus reported net losses for 2021 Q4 of $45.7 million, or $0.60 per share on a diluted basis compared with totals recorded in the same period in 2020; net losses were also recorded for 2021 as a whole ($287.1 million, or $3.81 per share on a diluted basis, compared with net income of $132.2 million, or $1.62 per share, on a diluted basis for 2020).

From 2020 to 2021, research and development (R&D) costs increased from $142.8 million to $363.1 million, due in large part to an upfront license fee paid to Junshi Biosciences. Costs incurred from the development of Yusimry, toripalimab and additional presentations of Udenyca also contributed to the $220.3 million rise.

Selling, general, and administrative (SG&A) costs increased year over year from $139.2 million in 2020 to $169.7 million in 2021.

In 2022, Coherus expects to launch 2 new products and initiate a clinical trial evaluating toripalimab in combination with JS006, company CEO Denny Lanfear said.

“Looking ahead to 2023, we project accelerating revenue growth with the planned launch of FDA-approved Yusimry into the $17 billion Humira market and the introduction of the Udenyca on-body injector, if approved, a new presentation that would enable us to address the remaining $1.2 billion Neulasta Onpro segment of the pegfilgrastim market where there is currently no biosimilar competition,” Lanfear added.

The company also projects combined R&D and SG&A expenses in 2022 will be in the range of $415 million to $450 million as a result of the anticipated new product launches and the additional presentation of Udenyca.

In its report, Coherus touted the FDA approval of 

 (adalimumab-aqvh), a Humira biosimilar in December 2021 and a biologics license application (BLA) for Cimerli (ranibizumab-ranq), a Lucentis biosimilar which has an assigned a target action date of August 2022.

An April 2022 target action date has been set for toripalimab’s BLA for the treatment of metastatic or recurrent nasopharyngeal carcinoma. It is currently under priority review by the FDA for this indication and is being studied for treatment of lung, breast, liver, skin, kidney, stomach, esophagus, and bladder cancers.

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Coherus released its earnings report for the last quarter of 2021 and for the year as a whole. 

Coherus Banks on 2022 Approvals After Net Losses for Q4, 2021

 show the subcutaneous (SC) form of infliximab, Remsima (CT-P13), yielded superior benefits in patients with inflammatory bowel disease (IBD) compared with intravenous (IV) dosing.

Findings presented at the European Crohn’s and Colitis Organization (ECCO) virtual congress 2022 also showed maintenance therapy with Remsima SC resulted in stable drug levels across a 14-day treatment cycle in a remitted patient with Crohn disease (CD), meaning drug monitoring could be performed at any time between the 2 injections, increasing patient convenience.

Celltrion’s infliximab was the first monoclonal antibody biosimilar to receive approval from the European Commission and is currently indicated for 8 autoimmune diseases, including IBD and rheumatoid arthritis.

Whereas infliximab IV must be given as an infusion over the course of 2 hours while patients are monitored for 1 to 2 hours afterward, the SC dose can be administered via a pre-filled pen, pre-filled syringe, or pre-filled syringe with needle safeguard. In the European Union, a 120 mg fixed dose of SC infliximab has been granted marketing authorization for adults regardless of body weight.

In the REMSWITCH study, 130 patients in remission (73% with CD and 26.9% with ulcerative colitis [UC]) were switched from 3 different IV dose regimens to SC infliximab at 120mg every 2 weeks.

After switching, analyses showed average Infliximab trough levels were significantly higher (9.8 [6.4] µg/ml vs 14.4 [5.7] µg/ml; 

<.0001), with levels increased among patients who underwent 5mg/kg/8weeks or 10mg/kg/8weeks IV regimen. Levels remained stable in those who were treated with 10mg/kg/6weeks or 10mg/kg/4weeks of IV Remsima.

Infliximab trough levels remained stable (variation V1-V0 (Visit 0 = V0) < [1]) in 4.3%, 15.0 %, 33.3 % and 50.0 % of the patients switched from the following IV doses respectively: 5mg/kg/8weeks, 10mg/kg/8weeks, 10mg/kg/6 weeks and 10mg/kg/4 weeks (

Clinical relapse after switching, which leads to therapeutic escalation, was observed in 11.1% and dose increase (240mg/2weeks) induced clinical remission in 93.3% of relapsed patients

The risk of relapse was higher in patients with stable or decreasing trough levels after the switch, compared to those with increased trough levels (31.8% vs 7.1%; 

Patients reported greater acceptability of the SC injection compared with IV infusions.

Additional research was presented from the RDTM study evaluating intra-individual variations of the drug levels at different time points throughout 2 consecutive cycles of maintenance therapy.

“This is the first real-world study analyzing serum levels of infliximab at different time-points between 2 SC injections of infliximab and during 2 cycles at steady state during maintenance regimen in remitted CD patient,” said Xavier Roblin, MD, of the department of gastroenterology at the University Hospital of Saint-Etienne in France. “Our results clearly demonstrated stable levels of infliximab all over this period.”

Approximately 5 million individuals worldwide suffer from IBD.

Data presented by Celltrion Healthcare at the European Crohn’s and Colitis Organization outlined the benefits of subcutaneous (SC) infliximab. 

SC Infliximab Superior to IV Dosage in Patients With Crohn Disease, Ulcerative Colitis 

The introduction of biosimilars in the US market brings along specific challenges to health system pharmacists, including formulary assessment, implementation, and education of patients and various health system stakeholders, according to a review published in Drugs In Context.

Despite the Biologics Price Competition and Innovation Act (BPCIA) being passed in 2009, the US FDA approved its first biosimilar in 2015. As of February 2020, 24 other biosimilars have been approved while only 11 have launched. In comparison, the European Union has had over 50 biosimilars approved since 2006.

Health system pharmacists ought to carefully review product labels of the biosimilar and its reference product (RP) to understand how differences can affect clinical practice and formulary decisions, researchers note. Some biosimilars and their reference products have differing storage and dosing requirements. “As multiple biosimilars for a given RP enter the market, these activities will become progressively more challenging,” authors said.

Changes in conventional naming practices also have to be taken into account and accurately reflected in electronic medical records. Mistakes in the transition to nonproprietary biologic names could result in errors involving inventory management, pharmacovigilance, and patient safety.

In the United States, an interchangeability designation can only be achieved independently from the initial approval of a biosimilar. Because of this, biosimilars may never achieve interchangeability. In the absence of the designation, “substitution may still occur but only with the documented prescriber, and possibly patient, notification and/or consent, as stipulated by state-level laws,” researchers said.

There are multiple distinctions in labeling indications between biosimilars and brand products, and pharmacists must become familiar with these to be of maximum service to patients and physicians, according to a review.

Study: Pharmacists Should Learn Nuances of Biosimilars

On February 6, the US FDA published a new 

 entitled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLA before a certain date.

“As part of its review, FDA assesses the manufacturing process and the manufacturer’s strategy to control within-product variations. These control strategies are put in place to help ensure that manufacturers produce biological products with consistent clinical performance,” the FDA 

The draft provides recommendations to applicants who are seeking licenses for a proposed biosimilar or interchangeable application supplements, with the aim of expediting reviews for biosimilars supplements. It can also be used to update initial biosimilar approvals when it is for fewer than all the reference product’s approved conditions.

According to the guidance, biosimilars or interchangeable products cannot be licensed for an indication by the FDA if they are protected by orphan drug exclusivity or pediatric exclusivity, until that exclusivity expires. Applicants can submit a supplement to the licensed 351(k) BLA for the previously protected indication once any exclusivity or patent expires.

The FDA recommends that when possible, an applicant who is seeking licensure for a proposed interchangeable product also seek licensure for all of the reference product’s licensed conditions of use.

Proposed biosimilar labeling will be dependent on whether the applicant seeks licensure for all or fewer of the conditions of use licensed for the reference product, according to RAPS.

Electronic or written comments on the draft can be 

 until April 7, 2020, before the final version of the guidance is released.

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.

FDA Hopes to Accelerate Biosimilar Supplement Reviews

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) Friday 

 marketing authorization for Pfizer's Ruxience, its rituximab biosimilar.

The opinion of the CHMP will be reviewed by the European Commission, and a regulatory decision could be announced in the next 6 months. If approved, Ruxience will be Pfizer’s fifth regulated oncology biosimilar in Europe. Ruxience was 

 by the FDA in July of 2019 and launched January last in the United States.

The originator rituximab is sold as Rituxan in the United States and and as MabThera in Europe and other regulatory territories.

, Ruxience will be available as 100- and 500-mg concentrates for solution for infusion. Rituximab is used in conditions such as non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris, according to a 

The chief development officer of oncology at Pfizer Global Product and Development, Chris Boshoff, MD, PhD, said of the authorization, “Biosimilars like Ruxience can play an important role in cancer care, helping to expand patient access to potentially life-changing therapies. We are committed to bringing biosimilars like Ruxience to the market as a treatment option with similar safety and efficacy to the originator product at a potentially lower cost.”

The regulatory submission is supplemented by results form a clinical comparative study, which “found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma,” according to the company.

 it expects its 3 oncology biosimilar products to have the lowest wholesale acquisition cost (WAC) among currently available bevacizumab, rituximab, or trastuzumab biosimilars in the United States. Ruxience has a WAC of $71.68 per 10 mg, which is a 24% discount to the WAC of rituxan.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Pfizer's Ruxience, a rituximab biosimilar. 
 

European Medicines Agency Authorizes Marketing of Pfizer's Ruxience

In 2019, readers of The Center for Biosimilars

 gravitated toward content reflecting the future of the market. Contributors from Amgen and Coherus BioSciences drew in readers with their assessments of new developments and practices to increase savings for patients, while other contributors took a look at how FDA guidelines will impact biosimilars.

5. Safety and Scientific Standards First: Why Biosimilars Require Clinical Testing

In this article, author Gary Fanjiang, MD, MBA, MS, vice president of global development at Amgen, explains his view that analytical data alone is not “sufficient to demonstrate biosimilarity,” and that clinical testing must be carried out to fully evaluate new potential products. Highlighting the differences between a biosimilar and its reference product, the author stresses how useful comparative clinical testing can be. Fanjiang refutes the notion that clinical testing slows innovation while arguing that it boosts confidence in the regulatory approval process of biosimilars.

4. Biosimilars Access: It’s Time to Choose

Jim Hassard, MBA, claims that increasing biosimilar access and allowing patients to choose treatments is of paramount importance when it comes to ensuring the most beneficial outcomes. Hassard, the senior vice president of Coherus BioSciences, emphasizes that his company prides itself on its decision to seek “parity insurance coverage with originator biologics, giving doctors and patients the freedom to make the right decision for them.” Ending anticompetitive rebate agreements and granting patients access to lower-costing biosimilars is essential to creating extensive investment and development in the field, according to Hassard.

3. 2019: The Year that Interchangeability Might Chance the Biosimilars Landscape

As biosimilar manufacturers and other stakeholders aim to reduce costs and increase product uptake, a focus on interchangeability in the biosimilar landscape will follow, according to authors George C. Yu, JD, and Christopher Bruno, JD. FDA guidance on seeking interchangeability should ideally streamline regulatory pathways for biosimilars and create structured scientific criteria. However, “because no biosimilar products approved for marketing have yet been designated as interchangeable, biosimilar companies looking to establish interchangeability do not have a model to replicate,” according to the authors.

2. A Critical Analysis of the FDA Draft Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations

New draft guidelines from the FDA regarding the analytical testing of biosimilars to a reference product was released in June 2018. In this article, Author Sarfaraz K. Niazi, PhD, reviews the essential elements of the guidelines and identifies new features. In addition, the author outlines what he sees as deficiencies that may hinder faster development of biosimilars. Niazi states, “The new analytical assessment guidance, intended to replace the withdrawn guidance, provides clarification of several practices, yet leaves out many specifics for the sponsors to interpret.”

1. Biosimilars Market is Ripe for Cost Savings

Chad Pettit, MBA, the executive director of global value access and policy for Amgen’s biosimilars business unit, relays that the company is committed to delivering protentional savings on biosimilar products in the most-read contributor article of 2019. According to the IQVIA Institute for Human Data Science, projected annual savings resulting from biosimilar products could reach $60 billion in 2023. Pettit explains, “As a manufacturer of originator biologic products as well as biosimilars, we know that there’s no need for government policies to force prescribing of biosimilars,” adding that head-to-head competition between biosimilars can generate savings.

In 2019, readers of The Center for Biosimilars® gravitated toward content reflecting the future of the market. Contributors from Amgen and Coherus BioSciences drew in readers with their assessments of new developments and practices to increase savings for patients, while other contributors took a look at how FDA guidelines will impact biosimilars.
 

The Most-Read Contributor Articles of 2019

This year, interviews with industry experts were the most popular among readers of The Center for Biosimilars. Touching on topics like market performance, cost, and government regulations, officials and professionals weighed in on the debates surrounding biosimilars and offered their opinions on how the industry can improve.

5. Simon Rule, MD: The Impact of Subcutaneous Rituximab on Clinical Practice

Rule of Plymouth University Medical School explains how using subcutaneous rituximab in his own hospital has had a positive impact. Compared to intravenous administration, “the patient has the injection, it takes about 5 minutes, and they can leave,” when providers opt for subcutaneous brand-name rituximab. This increase in efficiency has cut down on time patients and their relatives have to spend in the hospital.

4. Michael Kolodziej, MD: How Payers Are Preparing for Biosimilars

Kolodziej discusses how the behavior of reference product manufacturers affects payers’ approaches biosimilars. If the reference product manufacturers don’t want to compete on price, Dr. Kolodziej predicts commercial payers, including Medicare Advantage, will enact a policy similar to the use of generic drugs.

3. Carol Lynch: Barriers to the US Biosimilars Market

In this interview, Lynch, of Sandoz US explains how various barriers inhibit the performance of approved products in the market. Litigation, along with other factors, prevents the expansion of a vibrant biosimilar healthcare system in the United States. She states, “one of the major barriers is actually around the contracting and rebating practices we see from some of the originator companies.”

2. Scott Gottlieb, MD: Phase 3 Trials and Biosimilars

Gottlieb, former commissioner of the FDA, lays out barriers in the market for biosimilars and discusses increasing efficiency in this interview. “I think there’s always going to be a need to do some level of clinical evaluation and have some component of clinical trials in order to prove the similarity or sameness of the biosimilar to the incumbent biologic, but I think that there are ways to continue to make that process more efficient,” Gottlieb said.

1. Suzette Kox, MPharm: The FDA's Guidance on Biosimilar Naming

In the most-viewed video from 2019, Secretary General of the International Generic and Biosimilar Medicines Association, Kox, discusses the FDA’s updated guidance for naming biosimilars. Calling the new measures “inconsistent” Kox says she believes they will create confusion among medical professionals.