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Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Articles

New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.

Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

A new study confirms KM118, a proposed biosimilar to pertuzumab, shows pharmacokinetic similarity and safety, paving the way for affordable HER2-positive breast cancer treatments.

Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab

The US biosimilar market evolves with 90 approvals, significant price drops, and new PBM models enhancing access to cost-effective therapies.

Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape

Alex Keeton serves as the executive director of the Biosimilars Council.

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

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

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Clinical

1.5 Credits / Gynecologic Cancer, Health Equity, Diversity & Inclusion, Oncology, Women's Health

Advancing Immunotherapy in Endometrial Cancer: A Managed Care Perspective on Personalized Care

1.5 Credits / Hematologic Cancer, Hematology, Oncology

Overcoming Operational and Clinical Barriers in Multiple Myeloma: Managed Care Strategies for Antibody-Based Regimens

Exploring Therapeutic Advances in Myelofibrosis and Key Considerations for Effective Management

1.0 Credit / General Pharmacy, Health Equity, Diversity & Inclusion, Law 

Payment for Pharmacist Services: 2025 Update

2.0 Credits / Immunology, Rare Diseases, Hematology

Paroxysmal Nocturnal Hemoglobinuria: Managed Care Strategies to Mitigate Burden and Enhance Outcomes

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

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

Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.

Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals

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

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