Skylar Jeremias

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.

In a report from CVS Health, interchangeability will not be a primary factor in driving the adoption of adalimumab biosimilars referencing Humira, contradicting predictions from other sources that believe the designation will impact prescribing habits.

Better familiarity with biosimilars is enabling government agencies to reevaluate their approval requirements and encouraging smaller manufacturers to invest in biosimilar development, said Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.

The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.

The FDA approved the prefilled autoinjector version of Coherus Biosciences’ pegfilgrastim biosimilar (Udenyca), which will allow for patients at risk of febrile neutropenia to administer a full dose of pegfilgrastim at home.

At the European Crohn’s and Colitis Organisation congress, Celltrion Healthcare shared positive safety and efficacy data on maintenance therapy including its infliximab biobetter allowing for subcutaneous administration, Remsima SC.

On this episode of Not So Different, we chronicle the latest gastroenterology news from February, including several updates on adalimumab and infliximab biosimilars and industry analyses on the utilization of these drugs and patient confidence in gastroenterologists’ recommendations.

As Eli Lilly and Company announces that it will slash prices for its insulin products and cap out-of-pocket costs for insulin, the company shared that it will launch its interchangeable insulin biosimilar, Rezvoglar, at a 78% discount to the originator (Lantus).

As a new wave of biosimilars to treat inflammatory bowel disease— an umbrella term for Crohn disease and ulcerative colitis—enter the US market, a lot of clinical and policy news regarding adalimumab and infliximab biosimilars emerged throughout the month of February.

Viatris’ earnings report for the full year of 2022 showed $1.95 billion of cash proceeds, which was largely driven by the sale of its biosimilar portfolio to Biocon Biologics.

On this episode of Not So Different, Vizient’s Carina Dolan, PharmD, MS, BCOP, expounds on some of the results from Vizient’s recent edition of its Pharmacy Market Outlook Report, including how inflation could influence biosimilar utilization.

In Cardinal Health’s 2023 Biosimilars Report, more than 60% of surveyed providers said they would only want to prescribe adalimumab biosimilars with interchangeability designations, suggesting the label may have a greater impact on uptake than originally expected.

Fresenius Kabi announced a global partnership with Formycon for an ustekinumab biosimilar; Similis Bio partners with Novel351K to co-develop 3 biosimilars; and Celltrion Healthcare launched its bevacizumab biosimilar in Japan.