News

The Association for Accessible Medicines’ report on Medicare Part D tiering revealed low coverage rates for insulin and adalimumab biosimilars across plans.

Switching to the biosimilar version of tocilizumab (BAT1806/BIIB800) showed similar effectiveness, safety, and tolerability compared with the original drug for patients with rheumatoid arthritis (RA) who had an inadequate response to methotrexate.

Germany-based biosimilar manufacturer STADA Arzneimittel reports strong financial performance in 2023 with double digit sales growth and billions in profits. The CEO credits the company’s success on their strong company culture and focus for innovation.

Two senators reintroduce the Increasing Access to Biosimilars Act, a bipartisan bill aimed at boosting competition and encouraging providers to prescribe biosimilars, to Congress.

Ha Kung Wong, JD, an intellectual property attorney, discusses lawsuits by drug companies aimed at delaying competition from biosimilars, but the effectiveness of these lawsuits in hindering biosimilar access remains uncertain.

A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.

Here are the top 5 biosimilar articles for the week of March 18, 2024.

In its latest earnings report, Sandoz championed 7% growth overall throughout 2023, including a 15% spike in biosimilar revenues.

Two posters presented at the American Academy of Dermatology (AAD) annual meeting examined the effects of switching from reference ustekinumab and adalimumab to biosimilar versions in patients with different types of psoriasis.

A large-scale study found that Omnitrope, a biosimilar growth hormone, is effective and well-tolerated in treating various growth disorders in children.

Government policies, including those related to prescribing incentives and interchangeability, need to be reworked to encourage biosimilar adoption and create meaningful savings for health systems, according to speakers at a recent webinar.

Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

A recent study used difference-in-difference analysis to assess adalimumab sales volumes and expenditures in 6 countries with and 8 countries without available biosimilar adalimumab products.

In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.

Posters from Association of Cancer Care Centers 50th Annual Meeting and Cancer Center Business Summit (AMCCBS) and the American Academy of Dermatology (AAD) highlight the benefits of incorporating biosimilars into electronic medical records and the biggest barriers for home injection of biologics.

A review looking back at the last 15 years of experience with the first filgrastim biosimilar (Zarxio) provides a detailed overview on how filgrastim biosimilars came to be and the evidence behind why oncologists have come to accept them as standard practice.

A study found combining trastuzumab biosimilar HLX02, pertuzumab, and chemotherapy was effective and safe for patients with HER2-positive metastatic breast cancer who progressed after prior trastuzumab therapy.

Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the biosimilar industry and the last 5 years of progress.

Intellectual property attorney, Ha Kung Wong, JD, discusses concerns about "bad patents" hindering biosimilar access, but assures that the FDA and United States Patent and Trademark Office are working to improve the system.

The adalimumab biosimilar SB5 was reported to be as safe and effective as the reference product in a review of randomized controlled trials and real-world studies on immune-mediated inflammatory diseases.

Here are the top 5 biosimilar articles for the week of March 4, 2024.

The FDA has approved Fresenius Kabi's tocilizumab biosimilar (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous and subcutaneous administration options.

Biocon Biologics settled with the maker of Eylea (aflibercept), announcing a launch date for its biosimilar competitor in Canada; Sandoz has officially acquired Cimerli, a ranibizumab biosimilar; AARP Medicare Rx from United Healthcare has added Cyltezo (adalimumab-adbm) and removed the originator (Humira) from its formulary.

Sandoz’ Wyost/Jubbonti (denosumab-bddz) references Prolia and Xgeva and can be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

A Chinese phase 3 trial found biosimilar QL1207 to be as effective and safe as reference aflibercept (Eylea) for the treatment of neovascular age-related macular degeneration (nAMD).

Sarfaraz K. Niazi, PhD, takes a look at the European Medicines Agency's (EMA) announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.

On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.

A retrospective study analyzing 3 years of treatment patterns for patients with Crohn disease on biologics found that while more patients received infliximab, adalimumab, and vedolizumab initially, ustekinumab showed the highest persistence and lowest dose escalation rate, indicating potentially better clinical response compared to other biologics.

Explore the dynamic world of global biosimilar markets and policies! What do you know about the international biosimilar industry?