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Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, explained the initial experience gastroenterologists have had with anti–tumor necrosis factor biosimilars and how new adalimumab biosimilars will impact the space.

A collaborative exercise with 16 health care organizations nets millions in savings.

Here are the top 5 biosimilar articles for the week of October 2, 2023.

Pfizer’s Abrilada (adalimumab-afzb) became the second biosimilar referencing Humira (adalimumab) to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.

A recent webinar featured an in-depth discussion on the impacts that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.

Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.

September was graced with several regulatory updates from around the world, including some European and Japanese approvals, as well as the FDA’s 2-day workshop on the current science behind clinical efficacy testing for biosimilars and streamlining biosimilar development.

On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

Nuances in classification for insulin biosimilars can lead to frequent areas of confusion, according to 2 pharmacists.

Here are the top 5 biosimilar articles for the week of September 25, 2023.

Compared with other biologics frequently used in China for moderate-to-severe psoriasis, secukinumab is the most cost-effective treatment option.

With the European Commission's (EC) approval of Tyruko, Europe receives its first natalizumab biosimilar and first biosimilar to treat multiple sclerosis (MS), while Coherus Biosciences received a complete response letter (CRL) for its biosimilar for Neulasta Onpro.

Patients with inflammatory bowel disease who underwent a switch from reference infliximab to a biosimilar and then back to the originator were more likely to discontinue their treatment than patients who underwent a single switch from the originator to a biosimilar.

Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (ARMD) that could increase Medicare costs, but biosimilars could help.

The House Committee members examined pricing tactics by PBMs and how they are harming patients across the country.

Here are the top 5 biosimilar articles for the week of September 18, 2023.

The European Commission approved the first aflibercept biosimilar, which will be used to treat patients with age-related macular degeneration and diabetic macular edema.

In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.

A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.

Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.

On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.

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

Growing use of innovator biologics, including those with biosimilar competition, has led to increased Medicare Part B drug expenditures, with the trend unlikely to stop.

An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.

A report from the Association for Accessible Medicines (AAM) highlighted the value of biosimilars and generics, revealing that lower-cost versions of originator products accumulated $408 billion for the US health care system in 2022.

Study results suggest an association between antidrug antibodies and nonresponse to biologic disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA).

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the value of interchangeability in the adalimumab space and predicts whether interchangeable biosimilars will become leaders in adoption.

An approval in Australia and positive recommendations for 2 biosimilars in Europe bring hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcases that some barriers remain.

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

Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.