News

Sandoz’ earnings report for the first half of 2024 revealed 29% growth in biosimilar revenue, as well as a 7% increase in net sales, showcasing the value of biosimilars for biopharmaceutical manufacturers.

Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.

Ivo Abraham, PhD, RN, University of Arizona Cancer Center, suggests implementing targeted educational strategies to overcome physician hesitancy towards biosimilar adoption.

A study comparing 2 different financial incentive programs in France to encourage adalimumab biosimilar use concluded that incentivizing individual clinical units was more effective than incentivizing entire hospitals.

Here are the top 5 biosimilar articles for the week of August 19, 2024.

Alvotech reported $236 million in revenue for the first 6 months of 2024, a 10-fold increase from the same period the year prior. The new figures come after the company received its first 2 FDA approvals in 2024.

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.

Biosimilar CT-P42 demonstrated comparable efficacy, safety, and tolerability to reference aflibercept in treating diabetic macular edema (DME).

CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.

In an interview, Ha Kung Wong, an intellectual property attorney, explained that the Biologics Price Competition and Innovation Act of 2009 provides a structured but optional "patent dance" for biosimilars, which helps streamline patent disputes, potentially reducing litigation and encouraging early settlements.

Here are the top 5 biosimilar articles for the week of August 12, 2024.

An analysis of subcutaneous biosimilar and originator tumor necrosis factor (TNF) inhibitors for rheumatic diseases found no significant differences in survival or discontinuation rates due to inefficacy or adverse events, with biosimilars showing lower overall discontinuation rates and higher retention rates.

Formycon's first half 2024 revenue was €26.9 million, boosted by its ranibizumab biosimilar sales but down from last year due to fewer upfront payments and deferred success payments.

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

Sarfaraz K. Niazi, PhD, argues that the S-150 bill, also known as the "Affordable Prescriptions for Patients Act of 2023," aims to reduce drug prices by addressing anti-competitive practices, such as patent thickets and product hopping, which hinder the entry of cheaper biosimilars and generics into the market.

Ivo Abraham, PhD, RN, University of Arizona Cancer Center, focused on the cost savings generated by biosimilars and how crucial reinvesting those savings into broader patient access to care is. This approach has the potential to improve health care equity and expand treatment options for patients.

Artificial intelligence (AI) technologies can support global health systems in integrating biosimilars into care models, reducing health care costs, enhancing treatment decision-making strategies, and narrowing the gap between high-income and low- and middle-income countries.

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

In a comprehensive analysis, the biosimilar SB15 exhibited high similarity to reference aflibercept in terms of physicochemical and biological properties.

Manitoba’s new policy means that all 10 Canadian provinces now have an initiative to boost biosimilar adoption and savings by transitioning patients on reference agents to biosimilar options.

Several companies receive good news regarding their ustekinumab biosimilars; Lupin Limited completes a phase 3 trial for a ranibizumab candidate; Julie Reed, MS, executive director of the Biosimilars Forum weighs in on pharmacy benefit managers and biosimilar access.

The introduction of biosimilar insulins, particularly insulin glargine, is crucial for improving insulin accessibility and adherence among patients with diabetes in India, according to a study evaluating expert opinions from Indian doctors.

On this episode of Not So Different, we review all the big biosimilar policy news from July, including discussions regarding biosimilar policies, in both the US and abroad, as well as 3 highly anticipated FDA approvals.

Products in line to face biosimilar competition are projected to increase their list prices in advance, according to Vizient’s Pharmacy Market Outlook Report for Summer 2024.

Here are the top 5 biosimilar articles for the week of July 29, 2024.

July brought a lot of discussion regarding biosimilar policies, in both the US and abroad, as well as 3 highly anticipated FDA approvals.

The number of FDA-approved biologics has exploded, and biosimilars are making their mark.

Value-driven health care strategies in Singapore’s public institutions have significantly increased biosimilar adoption, leading to reduced treatment costs and substantial savings for the health care system, according to a recent study.

The FDA's new policy on glycan profiling of monoclonal antibodies (Mabs) receives praise and recommendations from Sarfaraz K. Niazi, PhD.

Ivo Abraham, PhD, RN, University of Arizona Cancer Center, recognizes the importance of stringent safety measures for biosimilar approvals. However, he advocates for utilizing statistical models and placing emphasis on postmarket safety data collection.