News

The top 5 oncology biosimilar articles in 2024 cover Duke's recommendations for cell and gene therapy biosimilars, FDA approval of Shanghai Henlius Biotech's trastuzumab biosimilar, Boehringer Ingelheim layoffs, the safety of rituximab biosimilar CT-P10, and more.

The top legal stories in biosimilars from 2024 emphasize the ongoing struggle between ensuring timely patient access and addressing challenges like litigation, regulatory hurdles, and patent disputes that shape the competitive landscape of affordable biologics.

Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.

The top gastroenterology biosimilar news from 2024 highlight fluctuations in the adalimumab biosimilar market throughout the year, while FDA and European approvals for ustekinumab biosimilars are set to improve access and reduce costs for patients with Crohn disease and ulcerative colitis.

Here are the top 5 biosimilar articles for the week of December 16, 2024.

China's trastuzumab biosimilar market is growing but lags behind European countries, with biosimilars gradually increasing market share and reducing costs despite initial barriers.

The FDA approved Celltrion's Steqeyma (ustekinumab-stba), making it the seventh biosimilar slated to compete against blockbuster Stelara (reference ustekinumab) in 2025.

Recent discussions at an Institute for Value-Based Medicine event highlighted the significant potential of biosimilars in reshaping the health care landscape, despite facing considerable barriers to adoption.

A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.

A recent study showed similar safety and efficacy of a bevacizumab biosimilar compared with the reference product (Avastin) in patients with metastatic colorectal cancer (CRC).

Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.

Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discussed barriers to biosimilar adoption and highlighted strategies such as physician education, streamlined implementation, payer collaboration, and patient engagement to improve access, reduce costs, and enhance adherence to biologic therapies.

A real-world study in France found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.

The impact of pharmaceutical companies' evergreening strategies on the adoption of trastuzumab biosimilars in the Netherlands led to significant price reductions and increased market share.

Here are the top 5 biosimilar articles for the week of December 9, 2024.

Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.

The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.

Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.

The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.

Steve Pickette, PharmD, BCPS, emphasizes that AI can streamline prescribing and formulary management for biosimilars and generics, enhance provider engagement, and improve pharmacovigilance by tracking adoption rates and identifying potential issues.

A French real-world study found that the adalimumab biosimilar SB5 was effective in treating rheumatic or gastrointestinal immune-mediated inflammatory diseases, showing no loss of disease control in switched patients and similar persistence rates between naive and switched groups.

Here are the top 5 biosimilar articles for the week of December 2, 2024.

Patients with oncohematological diseases switching to rituximab biosimilars experienced similar safety and efficacy, highlighting biosimilars' potential for cost-effective treatment across various medical conditions.

Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.

The study highlights the safety, efficacy, and cost benefits of infliximab biosimilars in managing pediatric noninfectious uveitis, showing fewer disease flares and reduced costs compared with reference infliximab, as well as the influence of insurance mandates on treatment decisions.

Veterans with inflammatory bowel disease (IBD) prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.

On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.

In November 2024, Skyrizi surpassed Humira as AbbVie's top seller; calls for PBM transparency and biosimilar access reforms grew; Celltrion expanded its portfolio; and Global Biosimilars Week focused on improving affordability and equity.

Here are the top 5 biosimilar articles for the week of November 25, 2024.