Biosimilars

The AJMC® Biosimilars compendium is a comprehensive resource for news and expert insights into these biological products, including clinical research, patent and legal news, and regulatory updates.

Latest News

FDA approval with stamp. | Image Credit: Surendra - stock.adobe.com
FDA Approves Seventh Ustekinumab Biosimilar to Reference Stelara

December 20th 2024

The FDA granted approval to Steqeyma (ustekinumab-stba) for inflammatory conditions, making it the seventh biosimilar to reference Stelara after a year of multiple ustekinumab biosimilar approvals.

AJMC
Uptake of Rituximab Biosimilars in Medicare and Medicaid in 2019-2022

December 16th 2024

Seattle Washington skyline | Image Credit: © espiegle - stock.adobe.com
From Approval to Practice: Addressing the Hurdles in Biosimilar Integration

December 12th 2024

Health Policy. | Image Credit: Mohamad Zaki - stock.adobe.com
Policy Proposals Aim to Stimulate the Long-Term Sustainability of Infused Biosimilars

December 4th 2024

FDA approval. | Image Credit: syahrir - stock.adobe.com
FDA Approves Sixth Ustekinumab Biosimilar, Yesintek

December 2nd 2024

More News

Top biosimilars articles
December 22nd 2021

Top 5 Most-Read Biosimilars News of 2021

Laura Joszt, MA
This year the United States only approved 2 biosimilars, but the FDA did grant interchangeable status to the first biosimilar.
No Easy Path to Market for Alvotech's Adalimumab Biosimilar
December 20th 2021

No Easy Path to Market for Alvotech's Adalimumab Biosimilar

Tony Hagen
In hopes of protecting its lucrative adalimumab (Humira) franchise, AbbVie is mounting a hefty legal defense against Alvotech's adalimumab biosimilar candidate.
Findings Are Reported From De-Escalation Therapy in Early Breast Cancer
December 15th 2021

Findings Are Reported From De-escalation Therapy in Early Breast Cancer

Tony Hagen
Investigators said pathologic complete response was higher with a molecularly selected subgroup of patients with early-stage breast cancer treated with a nonchemotherapy combination that included a trastuzumab biosimilar.
Surveys Probe Biosimilars in Oncology
December 13th 2021

Surveys Probe Biosimilars in Oncology

Tony Hagen
Recent surveys shed light on oncologist and patient perceptions of the switch to biosimilars and patient mental health.
Investigators Estimate Cost of Extending HER2-Directed Therapy With Biosimilars in British Columbia
December 8th 2021

Investigators Estimate Cost of Extending HER2-Directed Therapy With Biosimilars in British Columbia

Tony Hagen
Costs of extending human epidermal growth factor receptor 2 (HER2) therapy for patients with metastatic breast cancer were estimated in a retrospective study.
Investigators Initiate Post-Trastuzumab Trial of GLSI-100 in Patients With Invasive Breast Cancer
December 7th 2021

Investigators Initiate Post-Trastuzumab Trial of GLSI-100 in Patients With Invasive Breast Cancer

Tony Hagen
Investigators hope to duplicate promising phase 2b trial results with an experimental peptide vaccine in a population of nearly 500 patients with human epidermal growth factor receptor 2 breast cancer.
an image of a humira pen and box with a gun sight over it
December 2nd 2021

Field of Potential Adalimumab Biosimilar Contenders Continues to Grow

Tony Hagen
The list of potential adalimumab biosimilars has now lengthened to 10, according to a Cardinal Health summary of these products and their distinguishing features.
Opinion: Higher Biosimilar Savings Are Possible Under Medicare Part B
November 30th 2021

Proponents of Uniform Billing Codes for Biosimilars Cite Generic Savings Success

Tony Hagen
Generics and biosimilars are reimbursed differently, causing providers to prefer lower-cost generics and higher-priced biologics, authors of a study and opinion piece contend.
AMCP Nexus Survey: Two-Thirds of Payers Use Biosimilars to Manage Oncology Drug Costs
November 23rd 2021

AMCP Nexus Survey: Two-Thirds of Payers Use Biosimilars to Manage Oncology Drug Costs

Laura Joszt, MA
As the cost of oncology drugs increases, there has been a growing pressure to manage oncology drug spend, which some payers have done by establishing preferred therapies, including biosimilars.
EU and WHO Authorities "Tailor" the Biosimilar Development Process
November 23rd 2021

EMA and WHO "Tailor" the Biosimilar Development Process

Tony Hagen
The European Medicines Agency (EMA) reports on progress to create a smoother, less wasteful biosimilar development process; and the World Health Organization (WHO) revises its biosimilar development guidelines.
AAM Panel of Manufacturers Say Drug Price Rebates Must Go
November 16th 2021

AAM Panel of Manufacturers Says Drug Price Rebates Must Go

Tony Hagen
Sandoz, Lupin, and Biocon Biologics representatives at the Association for Accessible Medicines (AAM) GRx+Biosims conference said that drug price rebates hinder biosimilar competition.
COA Reports on Biosimilar Patient Access, Payer Barriers
November 15th 2021

COA Reports Improved Biosimilar Access in Oncology

Tony Hagen
For trastuzumab and bevacizumab, biosimilars now represent a high share of administrations, but payer policies still hinder uptake of these products, the Community Oncology Alliance (COA) reports.
Alvotech Is Among Companies Leading the Charge for Interchangeables
November 11th 2021

Biosimilar Interchangeability: What's in a Name?

Tony Hagen
There is now a mad scramble to gain interchangeable status for biosimilars, but the meaning and significance of this appellation haven't yet been worked out for health care consumers or the manufacturing community.
fda
November 9th 2021

FDA Deputy Director Discusses Initiatives to Advance Biosimilar Use

Tony Hagen
An overview of activities at the FDA to promote the use of biosimilars was presented by Jacqueline Corrigan-Curay, JD, MD, principal deputy center director for the Center for Drug Evaluation and Research (CDER) at the FDA.
Pharmacy Policy Experts Describe Changes in Biosimilar Adoption Curve
November 1st 2021

Pharmacy Policy Experts Describe Changes in Biosimilar Adoption Curve

Tony Hagen
Pharmacy experts from IPD Analytics explained the potential for authorized biologics, which would compete, potentially on the same price footing, with biosimilars.
Cate Lockhart, PhD, PharmD, MS
October 28th 2021

Dr Cate Lockhart Discusses Deciding Between Trastuzumab Biosimilars

There are a number of trastuzumab biosimilars available, but so far there have not been any patient characteristics that have played a role in which ones are prescribed, said Cate Lockhart, PhD, PharmD, MS, program, director, Biologics and Biosimilars Collective Intelligence Consortium.
Surveys on Biosimilar Awareness and Acceptance Reported at AMCP Nexus 2021
October 25th 2021

Surveys on Biosimilar Awareness and Acceptance Reported at AMCP Nexus 2021

Tony Hagen
Education is needed for both patients and pharmacists to ensure appropriate understanding, investigators reported at the Academy of Managed Care Pharmacy (AMCP) Nexus 2021 meeting.
Pills.
October 20th 2021

Adalimumab Biosimilar Shows Equivalent Efficacy, Safety to Reference Humira for Psoriasis

Matthew Gavidia
Adalimumab biosimilar AVT02 exhibited comparative efficacy, safety, tolerability, and immunogenicity to the reference drug Humira in patients with moderate-to-severe chronic plaque psoriasis.
Kirollos Hanna, PharmD
October 16th 2021

Dr Kirollos Hanna Details How His Practice Chooses Which Biosimilars to Add to Its Formulary

Kirollos Hanna, PharmD, manager of Oncology Pharmacy at the University of Minnesota Medical Center, explains the process behind how his practice chooses which biosimilars to stock and provide for patients.
IV drip bag
October 12th 2021

Reference, Biosimilar Pegfilgrastim Can Be Safely Administered Same Day as Chemotherapy

Skylar Jeremias
Investigators concluded that reference or biosimilar pegfilgrastim could be safely administered to patients with lymphoma on the same day they receive chemotherapy, which could reduce scheduling burden and risk of COVID-19 exposure.
Dr Kirollos Hanna Talks About How His Practice Has Fared With Uptake of Oncology Biosimilars
October 9th 2021

Dr Kirollos Hanna Talks About How His Practice Has Fared With Uptake of Oncology Biosimilars

Kirollos Hanna, PharmD, manager of Oncology Pharmacy at the University of Minnesota Medical Center, discusses the uptake of oncology biosimilars at his practice.
doctor talking to older woman sitting while receiving chemotherapy
October 6th 2021

Despite Awareness of Biosimilars, More Education Among Oncologists in Brazil Needed

Skylar Jeremias
Brazilian oncologists showed a solid knowledge base about biosimilars and their safety; however, concerns over extrapolation and interchangeability requirements remained, suggesting that more education on these subjects is needed.
Kashyap Patel, MD
October 2nd 2021

Dr Kashyap Patel: Misleading Reference Product Advertising and the Damage to Biosimlars' Reputation

Regulatory agencies have already begun calling companies out for misdirecting the public about the safety and efficacy of reference products in comparison to biosimilars, and it's important to continue to do so, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.
doctor holding a hologram of lungs
October 1st 2021

Bevacizumab Biosimilar Found to Have Safety, Efficacy Equivalent to Reference Avastin for NSCLC

Skylar Jeremias
Bevacizumab biosimilar LY01008 demonstrated comparative safety, efficacy, immunogenicity, and pharmacokinetic profiles to the reference product Avastin when combined with paclitaxel and carboplatin in patients with non–small cell lung cancer (NSCLC).
Kashyap Patel, MD
September 24th 2021

Dr Kashyap Patel: How COVID-19 Is Expected to Influence Usage of Biosimilar Pegfilgrastims

The emergence of new COVID-19 variants and the lower-than-anticipated vaccination rates could lead to a greater use of pegfilgratim biosimilars in cancer settings, explained Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.
FDA logo
September 20th 2021

FDA Approves First Biosimilar for Lucentis

Skylar Jeremias
Byooviz becomes the first FDA-approved ophthalmology biosimilar and the first FDA-approved biosimilar referencing Lucentis (ranibizumab), according to a statement from developers Samsung Bioepis and Biogen.
Kashyap Patel, MD
September 17th 2021

Dr Kashyap Patel: The Pros and Cons of Pegfilgrastim Biosimilars vs Neulasta Onpro

Cost and lack of insurance are big drivers of why a physician may choose to prescribe a pegfilgrastim biosimilar over the convenient on-body device for the originator, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates.
cancer cell superimposed over an image of a doctor wearing latex gloves touching an IV
September 15th 2021

Samsung Bioepis Releases Positive 5-Year Follow-up Results for Trastuzumab Biosimilar

Skylar Jeremias
Samsung Bioepis found during a 5-year follow-up study that Ontruzant, the company’s trastuzumab biosimilar, had comparable cardiac safety and long-term efficacy with the reference product Herceptin.
Kashyap Patel, MD
September 10th 2021

Dr Kashyap Patel Highlights How the Pandemic Influenced Utilization of Pegfilgrastim Biosimilars

Reducing the risks of secondary neutropenia, exposure to COVID-19, mortality, and financial toxicity were all major reasons the use of pegfilgrastim biosimilar gained traction during the pandemic, said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care.
2 men shaking hands
September 10th 2021

Sandoz, Bio-Thera Solutions Enter Deal to Commercialize Avastin Biosimilar

Skylar Jeremias
Bio-Thera Solutions and Sandoz have partnered for to allow for the commercialization of BAT1706, a bevacizumab biosimilar referencing Avastin, for the treatment of several forms of cancer.
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