News

In advance of the World Health Organization (WHO) updating its guidelines for biosimilar development, a review article concluded that comparative clinical efficacy and safety studies may not be helpful for the evaluation of biosimilars.

Here are the top 5 biosimilar articles for the week of August 29, 2022.

August brought with it 2 regulatory approvals for ophthalmology biosimilars, an FDA approval for a high-concentration adalimumab biosimilar, and the passage and signing of the Inflation Reduction Act of 2022.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, describes the pharmacoeconomics of biosimilars and the savings potential for practices and payers if they prioritize greater biosimilar adoption.

The European Commission granted marketing authorization to Teva’s ranibizumab biosimilar (Ranivisio), the second ophthalmology biosimilar and the second biosimilar to reference Lucentis to be approved in the European Union.

A review article chronicled the emergence of anti-inflammatory biosimilars in the United States and European Union and made predictions for where the market is headed, especially as etanercept and adalimumab biosimilars gain more prominence.

Here are the top 5 biosimilar articles for the week of August 22, 2022.

The move will create Europe's largest generics company.

Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare bone marrow disorder in which expansion of certain hematopoietic cells that lack a key protein cause the destruction of red blood cells, or hemolysis.

Vizient’s 2022 Biosimilar Survey found that health care organizations consider interchangeable designations to be very important in prescription decision-making, signaling the interchangeability could play a big role in the adoption of adalimumab biosimilars.

Researchers found that an infliximab biosimilar was as safe and effective as the reference product (Remicade) in pediatric patients with inflammatory bowel disease. However, more studies on adalimumab biosimilars in pediatric patients are needed.

Cheryl Vaughn, vice president of clinical services at McKesson, discussed how McKesson's Intrafusion service helps manage infusion sites and aids in the administration of complex biologic drugs, including biosimilars.

The European Commission (EC) authorized Celltrion Healthcare’s bevacizumab biosimilar referencing Avastin for marketing across the European Union, making it the seventh bevacizumab biosimilar to be approved in the region.

Here are the top 5 biosimilar articles for the week of August 15, 2022.

In response to another opinion piece, Craig Burton, from the Association for Accessible Medicines, argued that the Inflation Reduction Act of 2022 could prevent biosimilar competition, and lower drug prices as a result.

The FDA approval of Samsung Bioepis’ high-concentration, citrate-free formulation of Hadlima, a biosimilar referencing Humira (adalimumab), is the first high-concentration adalimumab biosimilar to be approved in the United States.

Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.

Researchers found that the percentage of biosimilar uptake is a better predictor of whether prices of biologics will significantly decrease, refuting the argument that more biosimilars for a single reference product will have the biggest impact.

A phase 1 study compared pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity between SB12, a proposed eculizumab biosimilar, and EU and US reference products (Soliris) in healthy adults.

Here are the top 5 biosimilar articles for the week of August 8, 2022.

Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act to 2022 that was passed in the Senate and critiques the argument that the bill should be considered a “price control” measure.

Study authors found the pair of biosimilars performed as well as others that have been evaluated in inflammatory bowel disease (IBD), but concluded that the adalimumab biosimilars were less effective in IBD than an infliximab biosimilar previously studied.

A systematic review found that patients who were switched from one biosimilar to another did not experience a change in clinical outcomes or an increase in adverse events.

While efforts to cap monthly insulin costs for Medicare patients at $35 survived a budget reconciliation bill in the Senate, Republicans blocked the measure from extending to the private sector.

On this episode of Not So Different, we recap some of the biggest biosimilars news that happened over the past month, including updates on clinical trials for oncology biosimilars as well as a survey on whether patients were given adequate information prior to switching a biosimilar.

In an interview with The Center for Biosimilars®, Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, breaks down the benefits of biobetters, how they differ from biosimilars, and how they could alter the future landscape of the biologics industry.

Here are the top 5 biosimilar articles for the week of August 1, 2022.

In a statement, Fresenius Kabi officials said the company is rapidly expanding its portfolio in autoimmune and oncology conditions.

Another ranibizumab biosimilar, Byooviz, is approved, but Coherus’ product is the first deemed interchangeable, which involves additional FDA requirements that allow substitution without intervention of the prescribing clinician.

Vizient’s Pharmacy Market Outlook report offers predictions on how the emergence of adalimumab biosimilars in 2023 will affect the biosimilar industry and what actions should be taken in advance to ensure biosimilar adoption.