Practice

Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.

The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries as well as possible solutions stakeholders can put into action.

Four pharmacists offer advice for clinics on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.

The Center for Biosimilars® provides an updated look on the adalimumab biosimilars that are coming down the US pipeline as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.

The Act4Biosimilars Action Plan seeks to increase biosimilar adoption by at least 30 percentage points in 30-plus countries by 2030.

Researchers of a retrospective cohort study found that a rituximab biosimilar, BCD-020, was safe and effective in pediatric patients with lupus nephritis.

Implementing strategies, such as dose rounding, can offset the impact of drug waste and reduce the total cost of care for value-based programs, according to a recent study of practices participating in the Oncology Care Model.

After 8 years of trastuzumab biosimilar competition and slow uptake, a new report shows that trastuzumab biosimilar discounts from the reference product (Herceptin) doubled between 2019 and 2022.

A survey of patients with rheumatoid arthritis found that those who had switched to an adalimumab biosimilar reported higher disease severity, poorer treatment adherence, and poorer quality of life compared with patients who stayed on the reference product, highlighting the dangers of the nocebo effect.

In light of 2 blockbuster originators, namely Humira (adalimumab) and Stelara (ustekinumab), losing market exclusivity in 2023, 3 doctors penned supplement in The American Journal of Managed Care®. On this episode, Vibeke Strand, MD, one of the co-authors, explored how health systems can take charge and boost biosimilar adoption.

The 2023 Asembia Specialty Pharmacy Summit featured Juliana (Julie) Reed, executive director of the Biosimilars Forum, who spoke on the challenges still facing the biosimilars industry and how they may impact the success of adalimumab biosimilars in the United States.

Colby Evans, MD, a dermatologist and co-author of an American Journal of Managed Care® supplement “Biosimilars for Immune-Mediated Inflammatory Diseases: 2022 Update" shares the managed care perspective on using biosimilars to treat inflammatory conditions.

In a study including 2 years of real-world evidence (RWE), patients with rheumatoid arthritis (RA) who were switched from originator rituximab (Rituxan) to GP2013, a rituximab biosimilar, experienced positive results and maintained clinical outcomes.

The authors of what they say is the largest and longest follow-up study comparing the trastuzumab biosimilar SB3 to the reference product (Herceptin) in HER2-positive breast cancer found “no clinically meaningful difference” between the biosimilar and the reference product.

In a panel at the 2023 Asembia Specialty Pharmacy Summit, speakers presented on the payer perspective regarding biosimilars, including that they feel comfortable preferring multiple biosimilars for the same reference product and are looking for interchangeability designations.

A review article investigating the use of bevacizumab biosimilars found that despite lingering concerns about their usage for extrapolated indications, bevacizumab biosimilars are regularly used in metastatic colorectal cancer (mCRC) even though clinical tests only evaluate them in patients with lung cancer.

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.

A retrospective study in Scotland found that multiple successive changes from originator infliximab to biosimilars seem to be safe and effective in patients with inflammatory bowel disease (IBD), irrespective of the number of switches.

Authors of a single-center, real-world study in Turkey found that patients with diffuse large B-cell lymphoma (DLBCL) who received a rituximab biosimilar had similar overall survival to patients who received the originator. However, progression-free survival was longer in the originator group.

A real-world study in India compared the ranibizumab biosimilar Razumab to the originator (Lucentis) in patients with polypoidal choroidal vasculopathy (PCV), finding that the biosimilar had comparable clinical outcomes.

Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, discusses the use of biosimilars and how pharmacy benefit managers (PBMs) as well as payers have challenged the biosimilar market.

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.

Although 75% of gastroenterologists believed that the efficacy of biosimilars and biologics were the same, most clinicians still preferred the brand name drug option.

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.

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.

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

A review of real-world studies assessing patient-reported outcome measures of patients with rheumatoid arthritis (RA) found that although clinical outcomes were similar, patients taking a biosimilar were found to have higher discontinuation rates, possibly as a result of the nocebo effect.

More and more women are becoming pregnant while on anti–tumor necrosis factor (TNF) biosimilars used to treat inflammatory disorders. However, there is “little data” on the safety and effectiveness of biosimilars in pregnancy, according to authors of a recent retrospective study.

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.

The FDA's new artificial intelligence (AI)-based modeling on characterizing protein aggregation could directly impact the safety assurance of biosimilars and other therapeutic proteins.