News

Continuous innovation is required in various technological aspects to effectively manage the challenges of vast clinical data.

Researchers of a literature review found similar safety profiles between biosimilar pegfilgrastim and its reference product (Neulasta) across several phase 1 and phase 3 clinical trials.

Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, shares why his study comparing the safety and efficacy of Cyltezo, an adalimumab biosimilar, with the originator (Humira) matters for patients with gastroenertology conditions.

Prince Edward Island became the eleventh jurisdiction in Canada to implement a biosimilar transition policy, in which patients who are currently taking select reference agents will transition to biosimilar versions.

Here are the top 5 biosimilar articles for the week of October 9, 2023.

An international comparative analysis found that the level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.

No safety or immunogenicity differences were found in patients who switched to a biosimilar and those who continued on a reference biologic or biosimilar.

Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.

At EURETINA 2023, Samsung Bioepis shared positive comparative efficacy data on its aflibercept biosimilar candidate, demonstrating that the product is as safe and effective as the originator (Eylea).

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.