Skylar Jeremias

Here are the top 5 biosimilar articles for the week of April 24, 2023.

Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar resulted in nocebo effect responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.

Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

Two US senators introduced a bipartisan bill to extend the $35 out-of-pocket cap for insulin products, established by the Inflation Reduction Act for Medicare plans, to the commercial sector.

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, expressed staunch belief that biosimilars referencing Neulasta Onpro, the on-body injector version of reference pegfilgrastim, are one of the most exciting things coming to the supportive cancer care space.

A study assessing factors that may determine a commercial health plan’s likelihood of covering a biosimilar found that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have coverage restrictions.

What can practices do to prepare for all the biosimilars to treat rheumatoid arthritis (RA) coming down the pipeline? And how can they ensure that the lower-than-anticipated adoption rates for infliximab biosimilars are not repeated? Robert Zutaut, RPh, from McKesson Provider Solutions, tackles all this and more on this episode of Not So Different.

In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.

The Committee for Medicinal Products for Human Use gave a thumbs up for an eculizumab biosimilar, and a biologic license application for a bevacizumab biosimilar was accepted in Brazil.

A retrospective real-world study assessing patient outcomes related to switching from reference rituximab (Rituxan) to a biosimilar version (Truxima) found that transitioning between the products was safe for patients and did not result in a change in adverse events.

Celltrion Healthcare shared data from a phase 3 clinical trial confirming that its omalizumab biosimilar had comparable safety and efficacy to the reference product (Xolair).

Upon coming into her position as the new chair of the Association for Accessible Medicines (AAM), Christine Baeder discussed what she believes the future holds for biosimilars, good and bad, and the questions that still surround the insulin price cap.

A retrospective study from India found that Razumab, a ranibizumab biosimilar, was safe and effective to use in infant patients with retinopathy of prematurity. This is the first analysis assessing the clinical outcomes associated with the biosimilar in this population.

The European Union gained another high-concentration adalimumab biosimilar with the approval of Sandoz’ Hyrimoz HCF and the FDA accepted a biologics license application for a trastuzumab biosimilar (HLX02).

In IQVIA’s latest report, neurologists in Europe reported feeling positive about the biosimilars for multiple sclerosis (MS) coming down the pipeline, showing that industry-wide education efforts and experience with biosimilars are working to instill greater confidence in these products.

STADA Arzneimittel and Xbrane Biopharma announced the launch of Ximluci, a ranibizumab biosimilar referencing Lucentis approved to treat ophthalmic conditions, across the European Union.

Although rheumatologists, dermatologists, and gastroenterologists rated their awareness of adalimumab biosimilars as high, a significant proportion of each group reported that they were not confident prescribing a biosimilar over the originator.

On this episode of Not So Different, we discuss some of the global biosimilar policy news that came out during the month of March, including a new bill in Congress and 2 Canadian jurisdictions implementing switching policies.

Eli Lilly and Company has launched its insulin glargine biosimilar, Rezvoglar (insulin glargine-aglr), on the US market, making it the second interchangeable insulin biosimilar to become commercially available to American patients with diabetes.

Policy updates around the world have garnered a lot of attention during March, and suggestions for practices could influence biosimilar adoption and acceptance.

Here are the top 5 biosimilar articles for the week of March 27, 2023.

Yukon, 1 of 3 Canadian territories, announced that it will implement a biosimilars switching policy, following Newfoundland and Labrador’s announcement to move forward with a similar policy earlier this week.

The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.

Newfoundland and Labrador is the latest Canadian province to implement a biosimilar switching policy, following in the footsteps of Ontario and 7 other jurisdictions.

In the wake of adalimumab biosimilars hitting the US market, Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health, hyped up the current biosimilar market trends and the other products coming down the pipeline during her talk at the Festival of Biologics.

At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.

At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum, warned that without changes to encourage biosimilar uptake, companies will begin to ask the big question: Are biosimilars worth investing in?

At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a phase 1 study comparing its ustekinumab biosimilars (SB17) with the reference product (Stelara).

On this episode of Not So Different, Mark Guyot, senior director of unity provider engagement at McKesson, gives an overview of McKesson’s real-world analysis of community oncology practices and their use of biosimilars and offers advice on overcoming adoption barriers and expanding education efforts.

In an article published in Frontiers in Pharmacology, researchers made recommendations to improve the biosimilar regulatory system and refine biosimilar guidelines in China.