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As more biosimilars are granted interchangeability status, 2 representatives from Samsung Bioepis stop misinformation in its tracks by clarifying that the designation will primarily impact pharmacy dispensing instead of prescription habits.

The second part of this 4-part series looks at what patients and employers can expect when adalimumab biosimilars hit the market.

As Alvotech’s biosimilars are included in a commercialization deal in the Philippines, the company hits a setback in its quest for FDA approval of its adalimumab biosimilar; the FDA gives EpiVax a $2 million grant to run immunogenicity testing for biosimilars.

As part of a larger series preparing for the US market entrance of adalimumab biosimilars in 2023, Steven Lucio, PharmD, BCPS, senior principal of pharmacy solutions at Vizient, makes predictions for how the rollout of these biosimilars may play out and offers advice to stakeholders for how to maintain a robust market.

A phase 1 study of an enoxaparin sodium biosimilar Cloti-Xa established similar pharmacodynamics and pharmacokinetic profiles with the reference product (Clexane, Lovenox) in healthy participants.

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

In a recent paper, Sarfaraz K. Niazi, PhD, argues that getting rid of clinical efficacy testing for biosimilars could realign testing ethics with current guidelines, save companies money on development, and improve data sensitivity.

Celltrion Healthcare released positive data for an ustekinumab biosimilar, and Samsung Bioepis announced long-term safety and efficacy results for its adalimumab biosimilar.

Fresenius Kabi announced the FDA approval of its pegfilgrastim biosimilar referencing Neulasta, making it the sixth pegfilgrastim biosimilar to be approved in the United States.

In the first article of a 4-part series, The Center for Biosimilars® offers specifics for each of the adalimumab biosimilar products coming in 2023 and explains why the experience in Europe may differ from what’s coming in the United States.

Thanks to the success of its adalimumab biosimilar in Canadian and European markets, Alvotech’s revenues reached over $40 million during the first 6 months of 2022, nearly 20 times more than its revenue from the same period in 2021.

On this episode of Not So Different, we look back at some of the biggest regulatory events to happen in the biosimilar space during August, including 2 European approvals, 2 US approvals, and the advancement of the Inflation Reduction Act of 2022.

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.