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BIOSIMILAR APPROVALS

Articles

Teva and Samsung Bioepis have launched Epysqli, a cost-saving Soliris biosimilar, offering a 30% discount and new hope for patients with rare, life-threatening hematologic conditions.

Teva and Samsung Bioepis Launch Biosimilar Epysqli 

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.

BioRationality: Commemorating the 15th Anniversary of the BPCIA

Early market entry, manufacturing efficiency, and market share are critical to biosimilar development success, while technical complexity and competition heavily impact returns, according to a study presenting a risk-adjusted net present value (NPV) analysis framework.

Risk-Adjusted NPV Framework for Biosimilars Shows Key Investment Drivers

High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025).

Early Success of Adalimumab Biosimilars Featured at AMCP 2025

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1rem

A phase 1 study testing Celltrion Healthcare’s omalizumab biosimilar in healthy subjects showed similar safety and pharmacokinetic profiles to the reference product (Xolair), as presented at the American Academy of Allergy Asthma and Immunology’s annual meeting.

Celltrion Biosimilar Demonstrates Equivalence With Xolair in Phase 1 Study

AAAAI Annual Meeting

If approved, Celltrion's CT-P16 would be the fourth bevacizumab biosimilar to reach the market.

Phase 3 Data Show Celltrion’s Bevacizumab Biosimilar Is Equivalent to Avastin in Lung Cancer

AACR

Better familiarity with biosimilars is enabling government agencies to reevaluate their approval requirements and encouraging smaller manufacturers to invest in biosimilar development, said Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.

IQVIA's Michael Kleinrock Shares Why Smaller Manufacturers Are Investing in Biosimilar Development

AAM Access! 

Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.

Pharmacy Economist Describes Fork in the Road for Generics and Biosimilars

AAM Biosimilars Council Conference

Specialty tiers for biosimilars and reforms that address the proliferation of poor-quality patents would help lower costs and improve access, biosimilar industry veterans said.

Biosimilar Industry Critiques Biden's Drug Pricing Reforms

AAM GRx+Biosims

Michael Chiang, MD, director of the National Eye Institute, discusses how his team is working to instill greater confidence in ophthalmology biosimilars among wary ophthalmologists.

Dr Michael Chiang: How the National Eye Institute Is Building Confidence in Ophthalmology Biosimilars

AAO: American Academy of Ophthalmology

Posters from Association of Cancer Care Centers 50th Annual Meeting and Cancer Center Business Summit (AMCCBS) and the American Academy of Dermatology (AAD) highlight the benefits of incorporating biosimilars into electronic medical records and the biggest barriers for home injection of biologics.

Posters From AMCCBS and AAD Showcase New Technology for Biosimilar Uptake, Barriers to Self-Injectable Biologics

ACCC Annual Conference

The Federal Trade Commission's powers to bring antitrust actions are circumscribed by public versus private and what is vs isn't "reasonable," Markus H. Meier explained.

Meier Explains FTC's Power to Pursue Antitrust Activity

ACI 11th Summit on Biosimilars & Innovator Biologics

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

ACR Convergence 2020

There is much inconsistency in the way physicians transition patients from insulin degludec to insulin glargine upon hospital admission, leading to higher risk especially for patients with type 1 diabetes, according to a study presented at the American Diabetes Association 80th Scientific Sessions online conference.
 

Doctors Manage Insulin Degludec-to-Glargine Transition Poorly, ADA Study Says

AMCP Nexus

Altering reimbursement procedures needs to become a bigger priority for government officials to incentivize biosimilar utilization, according to Eric Tichy, PharmD, MBA, vice chair of pharmacy formulary at the Mayo Clinic Health System.

Dr Eric Tichy Calls for Government Officials to Realign Incentives in Favor of Biosimilars

AMCP eLearning Days

AMCP: Academy of Managed Care Pharmacy

Two posters from the American Society of Clinical Oncology (ASCO) annual meeting look at Medicare reimbursement trends for originator and biosimilar biologics, as well as a combination therapy utilizing a pegfilgrastim biosimilar in patients with advanced hepatocellular carcinoma.

ASCO Posters Reflect on Reimbursement Trends, Combination Therapies Involving Biosimilars

ASCO

Findings from biosimilar studies of Kanjinti (trastuzumab) and Mvasi and Zirabev (bevacizumab) rounded out our oncology biosimilar coverage in January.

Oncology Biosimilar Roundup for January 2021

ASCO GI 

Biocon’s ustekinumab biosimilar matched reference ustekinumab in efficacy and safety, while an adalimumab biosimilar proved interchangeable with reference adalimumab, according to posters at the American Academy of Dermatology (AAD) annual meeting.

Promising Results for Ustekinumab, Adalimumab Biosimilars Presented at AAD

American Academy of Dermatology

A retrospective analysis of data from the US Veterans Affairs Healthcare System database provides positive switching data for infliximab products.

Samsung Bioepis Presents Real-World Switching Data for Renflexis

American College of Gastroenterology Annual Scientific Meeting

As the only anti–tumor necrosis factor therapies currently available to US patients with inflammatory diseases, biosimilars of infliximab are increasingly used to treat diseases like rheumatoid arthritis. While there are a wealth of data on real-world use of these products in territories like the European Union, less research has examined their use in the United States. During the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, researchers reported on the results of 3 studies that assessed real-world use of biosimilar infliximab in the US context.

Studies Report on Switching, Tolerability, and Infection Risk With Biosimilar Infliximab

American College of Rheumatology  Annual Meeting

Panelists at the American Conference Institute's 2021 meeting took on the complexities of biosimilar adoption in a wide-ranging discussion.  

ACI Panelists Discuss Misaligned Incentives in the Biosimilars Market

American Conference Institute: Summit on Biosimilars & Innovator Biologics

Health Canada has approved the high-concentration version of Samsung Bioepis and Organon’s Hadlima, a citrate-free adalimumab biosimilar referencing Humira.

Canada Approves High-Concentration Humira Biosimilar

American Society of Hematology  Annual Meeting and Exposition

Coherus BioSciences CEO Dennis M. Lanfear discusses the company's biosimilar marketing prospects in 2021.

Coherus CEO Discusses Post–COVID-19 Growth Prospects

Annual J.P. Morgan Healthcare Conference

Cencora's Lakesha Farmer, PharmD, MBA, discusses efforts that health care organizations can take to better educate patients and providers on biosimilars to improve biosimilar acceptance and achieve cost savings associated with these products.

Dr Lakesha Farmer Highlights Current Biosimilar Education, Acceptance Efforts

Asembia

At a session at the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the quest for rebates by pharmacy benefit managers (PBMs) prevents uptake on some biosimilars—and could soon bleed over into biosimilar formulary placement.

Prior Authorization Panel Yields Insights Into Role of PBMs in Biosimilar Uptake

Association of Community Cancer Centers 

Ned Pojskic, leader of pharmacy and health provider relations at the not-for-profit Green Shield Canada, the fourth largest private payer in Canada, discussed his organization’s efforts toward broad biosimilar adoption.

One Canadian Payer's Experience With Biosimilars

BioTech Pharma Summit:  Annual Biosimilars and Biologics

During the Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, a specialist pharmacist for a large National Health Service healthcare trust explained how the transition to biosimilars worked at a practical level in the UK home care system, and shared lessons learned from the experience.

Inside the UK Switch to Biosimilar Adalimumab

Biosimilars Commercialisation Summit

On the last day of the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, the head of the FDA practice at Avalere discussed her point of view that enabling a global reference product for biosimilars would provide global access for patients.

Is It Time for a Global Reference Product for Biosimilars?

CBI  Biosimilars Summit

Kathy Oubre, MS, a cochair of the biosimilars committee of the Community Oncology Alliance (COA), explains findings from a broad study of biosimilar use in oncology practices.  

COA Study: Biosimilars Have Broadened Patient Access in Oncology 

Community Oncology Alliance

At the Congress of European Crohn’s and Colitis Organisation (ECCO), Celltrion and Samsung Bioepis presented new finding from their respective biosimilar analyses, demonstrating positive safety and efficacy measures for the biosimilars as treatments for Crohn disease (CD) and ulcerative colitis (UC). 

Celltrion, Samsung Bioepis Unveil New Biosimilar Data in CD, UC at ECCO 2024

Congress of the European Crohn's and Colitis Organisation (ECCO)

Realigning definitions and policies across regulatory agencies and developing a better understanding of how different stakeholders approach biosimilars could help get more patients and providers on board with using biosimilars, according to panelists at the DIA Biosimilars Conference.

Policy Harmonization, Clarification Could Aid Biosimilar Uptake Efforts

DIA Biosimilars Conference

EHA is the annual meetting for the European Hematology Association.

Two posters presented at the European Hematology Association’s annual meeting (EHA 2024) evaluated how rituximab biosimilars impact quality of life and infusion-related reactions in patients with lymphatic cancers.

EHA 2024: Rituximab Biosimilars Improve Quality of Life, Infusion-Related Reactions

Investigators said TX05 met pathologic complete response criteria for equivalence to the originator product, Herceptin. The biosimilar candidate also fell within objective response rate, immunogenicity, safety, and tolerability margins for similarity. 

Tanvex Presents Positive Findings for Trastuzumab Candidate at ESMO

ESMO

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

Innovent Biologics Biosimilar Combination Surpasses Sorafenib in ORIENT-32

ESMO ASIA Virtual Congress 2020

Biosimilars from Samsung Bioepis have demonstrated equivalency in clinical trial and real world settings, according to 2 prominent cancer specialists. 

Planchard, Pegram Review Evidence for Samsung Bioepis Biosimilars

ESMO Virtual Congress 2020

Results from the European Congress of Rheumatology’s annual meeting revealed that Celltrion’s Remsima SC, a subcutaneous biobetter infliximab product, produced better clinical outcomes compared with the original Remsima, an infliximab biosimilar delivered intravenously.

Celltrion’s Infliximab Biobetter Shows Significant Clinical Improvements Over Original Biosimilar Version

EULAR

The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.

Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report

Festival of Biologics

A consultant who specializes in helping Chinese biosimilar companies market their products in the European Union discusses the challenges and opportunities. 

Expert Discusses Chinese Biosimilar Business Prospects in the European Union

Festival of Biologics Basel

By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.

Panelists Stress Stakeholder Education to Build Confidence in Biosimilars

GRx+Biosims

Panelists at the annual meeting of the International Generic and Biosimilar Medicines Association (IGBA) offered insight into the current state of the global biosimilar and generic markets and why government agencies need to leverage these medicines to address challenges in the pharmaceutical space.

IGBA Panelists Discuss the Global Reputation of Biosimilars, Generics

IGBA Annual Meeting

The great promise of biosimilars is their ability to provide high-quality treatment at a reduced cost, thereby producing cost savings that can be reapplied. But how are healthcare systems around the globe utilizing those cost savings? During the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting, held this week in Copenhagen, Denmark, several teams of researchers reported on how biosimilars are impacting international markets, and how they could provide headroom for new, expensive treatments.

Applying Biosimilar Savings in Markets Around the World

ISPOR Europe

As patients are being encouraged to self-manage disease and take an active role in their healthcare, communication with patients about the products that they use is becoming a hot topic among drug makers. During the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, stakeholders gathered to discuss new directions in providing digital information to patients.
 

EU Seeks to Digitize Drug Information for Easier Patient Use

Medicines For Europe  Regulatory and Scientific Affairs Conference

More transparency in how health care money is spent could improve utilization and efficiency, panelists said at the Medicines for Europe event.

Medicines for Europe Panel Targets Inefficiencies, Need for Education

Medicines for Europe  Biosimilar Medicines Conference

With white bagging, pharmacy benefit managers (PBMs) require certain high-cost drugs to be shipped from their own specialty pharmacies to practices, where clinicians then administer the drugs to patients.

NCCN Panel: How White Bagging Is Tied to High Drug Costs

NCCN  Virtual Annual Conference

A diverse panel from practice, payer, and wholesale perspectives convened at The American Journal of Managed Care®'s Patient-Centered Oncology Care® 2020 virtual conference to hash out one of the hottest issues in biosimilar availability right now.

Stakeholders Joust Over Biosimilar Availability at PCOC20 

PCOC Patient-Centered Oncology Care 

Pharmacy organizations such as the Academy of Managed Care Pharmacy (AMCP) and the Alliance of Community Health Plans (ACHP) are advocating for structural changes to health care based on lessons learned from the coronavirus disease 2019 (COVID-19) pandemic.

AMCP, ACHP Advocate for Health Care Improvements

PQA  Annual Meeting

“Talk about the success first,” said Steinar Madsen, MD, medical director of the Norwegian Medicines Agency. “Forget the nonexistent problems.”

When It Comes to Instilling Confidence, What's Said About Biosimilars Matters

SMi Biosimilars North America

Posters from San Antonio Breast Cancer Symposium 2023 found that combination therapies featuring trastuzumab biosimilars and other common cancer medicines were safe and effective in patients with breast cancer.

Posters Show Efficacy for Combination Therapies With Trastuzumab Biosimilars in Breast Cancer

San Antonio Breast Cancer Symposium

Positive findings for Coherus BioSciences' ranibizumab candidate (CHS-201) were presented at the Scientific Meeting of the Retina Society, and the company said equivalence end points were met for an on-body injector version of Udenyca (pegfilgrastim). 