Biosimilars

In 2024, there is an urgent need for policies that will accelerate biosimilar use to achieve lower system-wide health care costs.

Despite the insignificant differences in efficacy, biomarkers, therapeutic drug level, and ADAs, patients reported a significant number of nocebo effects.

Biosimilars are proven to be highly similar to the original products with no clinical meaningful differences.

Adalimumab-aqvh (Yusimry; Coherus Biosciences) entered the market in July 2023, following approval by the FDA in December 2021.

There was no statistically significant difference between Lovenox (Sanofi–Aventis Pharmaceuticals, France) and biosimilar enoxaparin in the occurrence of post-operative thrombosis for digestive cancer.

Liraglutide, a glucagon-like peptide 1 receptor agonist, has shown a clinically and significant reduction in glycated hemoglobin for those with type 2 diabetes.

From newsworthy moments to groundbreaking research, these were the most-read biosimilar-related articles on Pharmacy Times in 2023.

The aim of developing GP40141 as a biosimilar is to help reduce the cost of the drug and make treatment more affordable for those with idiopathic thrombocytopenic purpura, according to investigators.

The legal and common uses of “interchangeability” continue to be conflated.

The sBLA was based on data from a clinical study assessing the pharmacokinetics of switching between adalimumab and adalimumab-bwwd for patients with moderate to severe plaque psoriasis.

The biosimilar, now legally available at the pharmacy level, demonstrated similar safety, purity, and potency to the reference product.

Infliximab-dyyb (Zymfentra; Celltrion USA) is a subcutaneous treatment for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn disease.

Biosimilars in the pharmacy benefit are as effective as their reference drug, but it’s important for the pharmacist to clarify this to patients.

The biosimilar landscape is growing, but the FDA should leverage analytical data to efficiently determine the quality of these products and propel them toward approval, according to a session at the Academy of Managed Care Pharmacy’s Nexus 2023 conference.

The FDA is the only authority that can designate a biosimilar as interchangeable with its reference product, which requires that the product has similar clinical results for the same indication.

Jensen notes that although she expects there will be a lot of FDA approvals in 2023 and 2024, there likely will not be another biosimilar “boom” until 2025.

Following the results of a meta-analysis that reviewed biosimilar trial design and endpoints, investigators urge for greater biosimilar uptake initiatives.

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

In the first systematic review using statistical methods, investigators found switching from a reference biologic to a biosimilar was comparable in safety, but no conclusion on immunogenicity could be drawn.

The House Committee members examined pricing tactics by PBMs and how they are harming patients across the country.

Insulin glargine-yfgn is more affordable than the reference product and patients do not require prescriber authorization switch.

Nuances can lead to frequent areas of confusion.

A collaborative exercise with 16 health care organizations nets millions in savings.

The "interchangeable" designation has created confusion around the difference between biosimilars designated as interchangeable and those that are not.

Clinicians raise concerns about immunogenicity, product quality, and reimbursement for biosimilars.

The importance of findability, accessibility, interoperability, and reusability has become even more significant to academics as government agencies increasingly require data openness and accessibility for funding eligibility.

Manufacturers must find the right balance in drug pricing, so that medications are appealing to both public and private insurers while still remaining profitable throughout their lifecycle.

Enhanced utilization of biosimilar products can have significant impact on reducing the overall cost of health care and potentially reducing out-of-pocket costs for patients.

The seamless integration of artificial intelligence and machine learning has the potential to accelerate research and enhance efficiency in a new era of personalized medicine.

Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.