News

On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).

The biosimilar Enoxa (enoxaparin), marketed in Tunisia, demonstrated equivalence in preventing subclinical postoperative thrombotic events in patients with digestive cancers to Sanofi’s Lovenox, in a randomized controlled trial.

Here are the top 5 biosimilar articles for the week of December 11, 2023.

Two Taiwanese posters presented at the San Antonio Breast Cancer Symposium (SABCS) 2023 annual meeting evaluated the real-world implications of using trastuzumab biosimilars, particularly Ogivri (trastuzumab-dkst) in patients with HER2-postive breast cancer.

Biosim.care is a new interactive education tool that can help patients, caregivers, and providers navigate decision-making and treatment conversations for multiple disease states.

The FDA agreed to review an application for Hadlima (adalimumab biosimilar) to be granted interchangeability; The European Union’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for an ustekinumab biosimilar; the Biosimilars Forum expressed support for a Senate Finance Committee’s draft legislation promoting biosimilars.

A national study on patients with rheumatoid arthritis (RA) compares the disease activity and drug survival rate between an etanercept biosimilar and the originator (Enbrel).

Brian Biehn, senior director of biosimilar commercialization at Cencora, makes predictions for how big regulatory approvals in 2023 will shape the biosimilar space going forward.

A review article discussed the characteristics of the available adalimumab biosimilars to help clinicians navigate the various treatment options with their patients.

Here are the top 5 biosimilar articles for the week of December 4, 2023.

A simulation study estimated the impact of biosimilar substitution on total cost of care (TCOC) and provider financial performance in the final performance period of the Oncology Care Model.

Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.

Patients with inflammatory bowel disease (IBD) receive additional evidence on the safety and efficacy of adalimumab biosimilar GP2017 treatment.

Sarfaraz K. Niazi, PhD, comments on a poll he conducted revealing that many are still hesitant to remove clinical efficacy study requirements for biosimilars in his latest column.

On this episode, we discuss the abundance of oncology news from November, especially during Global Biosimilars Week 2023, which was themed around the growth of oncology biosimilars.

A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.

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

The Center for Biosimilars® covered an abundance of oncology news during November, especially during Global Biosimilars Week 2023, which was themed around the growth of oncology biosimilars.

A report from IQVIA noted that Europe could miss out on €15 billion in cost savings by not having biosimilars for medications about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.

Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.

As new biosimilars are added to CVS Caremark’s standard formulary, others are removed. One notable change is with the Humira biosimilars: the pharmacy benefit manager has removed Amjevita in favor of Hyrimoz and an unbranded biosimilar.

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, explains the purpose of dual-pricing strategies for adalimumab biosimilars and predicts whether these strategies will occur in other treatment spaces.

A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.

Here are the top 5 biosimilar articles for the week of November 20, 2023.

The legal and common uses of “interchangeability” continue to be conflated.

Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).

A China-based study where data were collected from patients with inflammatory bowel disease (IBD) showed safety and efficacy of the adalimumab biosimilar HS016.

Sarfaraz K. Niazi, PhD, offers hope for the end of interchangeability labels in the United States in his latest column.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, examines the evolution of the oncology biosimilar space in this special episode of Not So Different to close out Global Biosimilars Week 2023.

A retrospective study of New England patients receiving trastuzumab or bevacizumab found that combining dose rounding and biosimilar use resulted in greater cost savings than either strategy alone.