Bone Health

Immunology

Hematology

Respiratory

Dermatology

Diabetes

Gastroenterology

Neurology

Oncology

Ophthalmology

Rare Disease

Rheumatology

News

All News

Product Approvals and Launches

Media

All Videos

Insights

Interviews

Peer Exchange

Podcasts

Stakeholder Summit

Conferences

Conference Coverage

Conference Listing

CME/CE

Resources

Authors

Biosimilar Resources

Interactive Tools

Partners

Polls and Quizzes

WHEN CHOICE ARRIVES: Competition & Consequences

Subscribe

BIOSIMILAR APPROVALS

Articles

A study found no direct trial evidence for natalizumab or its biosimilar in MS and found limited cost-effectiveness vs most alternatives.

Natalizumab Biosimilar Shows Limited Cost-Effectiveness in MS

Most pediatric and young adult patients with IBD maintained stable disease activity and laboratory markers after switching from the adalimumab originator. 

Nonmedical Adalimumab Biosimilar Switch Maintains Disease Control in Pediatric IBD

Brooke McCormick is an assistant editor for 

Rituximab biosimilars showed no significant 6-month differences vs the originator in antineutrophil cytoplasmic antibody–associated vasculitis (AAV).

Rituximab Biosimilars Show Comparable 6-Month Outcomes in AAV

Analytical characterization supports monoclonal antibody biosimilar approvals and may reduce clinical testing needs, researchers found.

Analytical Characterization Supports Confidence in Monoclonal Antibody Biosimilars

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.

About

Contact

Advisory Board

Do Not Sell My Information

Terms & Conditions

Privacy Policy

The Center for Biosimilars - Biosimilars, Health Economics & Insights

Facebook

Twitter

LinkedIn

Business Practice

Business

Development

Legal

Policy

Practice

Regulatory

1rem

Clinical

Biosimilars of eculizumab, which have the potential to reduce costs for both patients and the healthcare system, have been eagerly awaited, yet many drug makers are developing novel anti-C5 agents.

New Anti-C5 Agents on the Way as Biosimilar Competition for Eculizumab Nears

In a recently published editorial in The Official Journal of the World Federation of Hemophilia, author Angela Thomas, MB, PhD, discusses the advancements in hemophilia treatment as well as the place biosimilars may or may not have in reducing the cost of care.

Biosimilars of Hemophilia Therapies: Are They Likely?

Patients in British Columbia, Canada, now have access to 3 new biosimilars for the prevention of blood clot disorders, all of which reference Lovenox (enoxaparin).

Redesca, Noromby, and Inclunox have been added to the list of reimburseable biosimilars covered by PharmaCare, the province’s public health plan. Noromby was developed by Juno Pharmaceuticals, Inclunox is a Sandoz product, and Redesca was developed by Valero Pharmaceuticals. Both the original and high-potency versions of the drugs are available for public reimbursement.

“We are very pleased to have secured public coverage for Redesca in British Columbia while its originator enoxaparin has been simultaneously delisted. Our biosimilar is now covered in every province, and it is already our best-selling drug. We anticipate further upside going forward now that it is publicly fully covered and that hospitals across the country are making the step to move to biosimilars LMWH [low molecular weight heparin]," said Frederic Fasano, president and chief operating officer at Valero, in a company 

Enoxaparin is a LMWH that acts as an anticoagulant medication for the treatment and prevention of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism both during pregnancy and following certain types of surgery. It is also used in patients with acute coronary syndrome and history of heart attacks and can serve as a replacement to oral blood thinners when other treatments for noncancer-related VTE have failed.

British Columbia is 1 of the 5 provinces and 6 jurisdictions that have a biosimilars 

 that enables reference products to be automatically substituted with a biosimilar version. British Columbia 

 its policy in November 2019, and in August 2020, it moved into the 

 of the program, which included the addition of 3 rituximab biosimilars to its list of options for patients to switch to from Rituxan.

 on November 30, 2021, which involves switching patients with type 1 or type 2 diabetes who are on or are scheduled to start therapy with the originator insulin lispro (Humalog) and insulin aspart (NovoRapid). By May 29, 2022, all patients will either have to switch or start therapy with biosimilars Admelog (insulin lispro) or Trurapi (insulin aspart) or risk losing coverage.

“Our government’s biosimilars program continues to help people in British Columbia save money by accessing more treatment options that are less expensive than the originator drug and are just as effective….The new biosimilars we are announcing will be of great assistance to those who develop blood clots, which can be deadly,” said Adrian Dix, Minister of Health, in a 

British Columbia officials specified that because enoxaparin is used in patients for less than 6 months, patients who are currently administered the reference product will not have to switch to a biosimilar and will be able to continue with their Lovenox prescription until their treatment course is complete.

Therefore, only patients who need to start a new enoxaparin treatment course will be administered a biosimilar. Exceptions may be granted for patients whose providers conclude that they are medically unable to take the biosimilars and whose exceptional coverage requests are approved by PharmaCare’s Special Authority branch.

Additionally, PharmaCare is updating how it provides coverage for treatments associated with cancer-related thrombosis, allowing patients with cancer to access dalteparin, enoxaparin, and tinzaparin without needing to try blood thinner warfarin first.

Three biosimilars used for blood clot prevention secure public reimbursement status in British Columbia, one of several Canadian provinces that has a biosimilar switching program.

Blood Clot Prevention Biosimilars Achieve Reimbursement in British Columbia

A 50-patient study found sustained platelet recovery and low thrombotic microangiopathy rates through 52 weeks of biosimilar therapy, with favorable safety.

Eculizumab Biosimilar Shows Durable Benefit in Long-Term aHUS

Biosimilar SB12 demonstrated comparable efficacy and safety for paroxysmal nocturnal hemoglobinuria (PNH) to its reference drug, showing similar outcomes across diverse patient groups.

Biosimilar SB12 Matches Eculizumab in PNH Treatment Across Diverse Patient Groups

Eculizumab biosimilars could provide European patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome better access to care for a better price, similar to successes seen in other biosimilar markets, according to a review.

Biosimilars Offer New Hope for European Patients Facing High Eculizumab Costs

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 

Eculizumab biosimilar Elizaria demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.

Long-Term Data Support Use of Eculizumab Biosimilar as Soliris Alternative in PNH

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

The European Hematology Association recently held its 25th Annual Congress, EHA25 Virtual, from June 11 through June 21. The meeting was conducted on a digital platform due to the coronavirus disease 2019 (COVID-19) pandemic and featured some key study findings and presentations on the up-and-coming world of hematology biosimilars.

The following is a summary of our biosimilar coverage from this event:

Investigators produced what they described as the 

 the use of biosimilar erythropoiesis-stimulating agents (ESAs) in patients with myelofibrosis (MF)-related anemia.

Investigators said ESAs are used to manage anemia in hematological malignancies, but scarce evidence exists for the use of these agents in the treatment of MF, and available results are divergent: Response rates range from 23% to 69%, according to the abstract presented at EHA25 Virtual. Until this study, there were no data on the use of biosimilar ESAs in this setting, investigators said.

Investigators reported an 88% overall response rate for a Sandoz rituximab biosimilar in combination with chemotherapy in patients with CD20-positive diffuse large B-cell lymphoma. At the end of treatment, the complete response was 57% and partial response was 31%. Investigators said 61% and 29% of patients experienced enlarged lymph nodes and disease-related pain, respectively.

 presented this month at EHA25 Virtual confirmed findings from the REFLECT study released in 2019, which was the first prospective postapproval study to evaluate a rituximab biosimilar in this context.

 that a rituximab biosimilar developed by Celltrion Healthcare (Truxima) in combination with lenalidomide and acalabrutinib (R2A) in patients with relapsed or refractory aggressive B-cell lymphoma was tolerable and effective.

The addition of rituximab, a targeted therapy, to chemotherapy agents can improve patient outcomes but adds to the financial burden of treatment. Investigators said that exploring the use of biosimilar rituximab may be an avenue to bring down costs.

To read all of these articles, visit our EHA 

Videos

Here is a summary of our coverage from EHA25 Virtual, the annual meeting for the European Hematology Association (EHA).

Hematology

Latest News

More News