Skylar Jeremias

On this episode of Not So Different, the end of the second quarter brings with it expense reports, new biosimilar business deals, and insights into how federal policy impacts biosimilar company pursuits.

With the end of the second quarter comes expense reports, new biosimilar business deals, and insights into how federal policy impacts biosimilar company pursuits.

The 2023 European Alliance of Associations for Rheumatology (EULAR) recommendations for psoriatic arthritis (PsA) provide an evidence-based treatment strategy, prioritizing conventional and biological disease-modifying antirheumatic drugs, including biosimilars, tailored to disease manifestations, with an emphasis on safety, cost-effectiveness, and patient-centered care.

Market remonopolization by a biosimilar drug in Poland led to significant price increases for etanercept, resulting in over €3.42 million in excess health care costs, according to a recent study.

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.

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.

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.

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.

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.

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.

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

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.

A biosimilar dulaglutide showed similar pharmacokinetic and safety profiles compared with the reference product Trulicity in healthy Chinese participants, according to a phase 1 analysis.

Boehringer Ingelheim (BI) partners with GoodRx to offer its unbranded adalimumab biosimilar to patients at an exclusive low price; a new ustekinumab biosimilar launches in Europe; and Mexican officials approve a bevacizumab biosimilar.

About half of the patients in a European study who transitioned from reference adalimumab to a biosimilar version stayed on the biosimilar at the 1-year mark. However, researchers warned about a possible nocebo effect resulting in some patients switching back to the originator.

The FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh), marking the second US approval for a biosimilar referencing Soliris (eculizumab).

Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.

The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.

The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.

A Brazilian real-world study found trastuzumab-dkst to be an effective and safe adjuvant therapy for HER2-positive (HER2+) breast cancer, with clinical outcomes comparable to reference trastuzumab.

On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.

As Celltrion publishes phase 3 data on its tocilizumab biosimilar, other companies finalize partnerships, and Formycon begins development for a pembrolizumab biosimilar.