News

After a patient with multiple sclerosis (MS) was forced to pay exorbitant out-of-pocket costs for a brand name medication when she could’ve gotten a generic for way less, the patient filed a class action complaint against her employer, Johnson & Johnson (J&J), for violating the Employee Retirement Income Security Act of 1974 (ERISA).

Similar efficacy, safety, pharmacokinetics, and immunogenicity were found when comparing Stelara, originator ustekinumab, and CT-P43, an ustekinumab biosimilar candidate, in patients with moderate to severe plaque psoriasis.

Celltrion announced that 3 of its oncology biosimilar products have won tender contracts in France and Italy, and an experimental oral delivery device utilizing an ustekinumab biosimilar was successful in a phase 1 study.

In an interview with Ha Kung Wong, JD, he addresses the patent legal system biosimilars are required to undergo and how this helps resolve patent disputes early in the development process.

The authors of a meta-analysis assessing several disease states found no significant differences in serious adverse events, deaths, or treatment discontinuations between patients who switched from reference products to biosimilars and those who did not.

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

To mark the 40th anniversary of the Hatch-Waxman Act, the Association for Accessible Medicines published a white paper outlining the benefits and challenges associated with the landmark policy as well as solutions to ensure a stable pharmaceutical industry for the future.

Vizient’s most recent Pharmacy Market Outlook report showcased the success of biosimilars while also emphasizing the impact of inflation on different drug classes, particularly in oncology and immunology.

Etanercept biosimilar SB4 is just as effective as the originator drug (Enbrel) in treating Australian patients with rheumatoid arthritis (RA), leading to significant cost savings.

In his latest column, Sarfaraz K. Niazi, PhD, highlights challenges in biosimilar development, emphasizing the crucial role of US Pharmacopeia (USP) and advocating for collaboration and standardized guidelines to expedite cost-effective development without compromising safety or efficacy.

On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.

The PERFUSE study in France on biosimilar adalimumab SB5 for inflammatory bowel disease reveals high satisfaction overall, but significant variations in training and survey response rates across sites suggest a potential lack of support during treatment switches.

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

In addition to the several reports that have come out quantifying how the gastroenterology biosimilar market is progressing, January marks the 1-year anniversary of adalimumab biosimilar competition in the US.

A study found SB15, an aflibercept biosimilar, is just as effective as its reference drug Eylea, the current standard treatment for neovascular age-related macular degeneration (nAMD), a condition that causes vision loss.

The Center for Biosimilars® looks back at the first year of adalimumab biosimilars on the US market, including every product launch and approval as well as market trends and pricing strategies.

Coherus Biosciences has sold its ranibizumab biosimilar (Cimerli) to Sandoz; Celltrion has completed its biologics license application filing for its tocilizumab biosimilar (CT-P47); Alvotech shares positive pharmacokinetic results for its denosumab biosimilar candidate.

Although manufacturing patents tend to be the most common type of patent referenced in litigation regarding biosimilar development, other patents actually have a greater impact on delays for biosimilar market launches.

During a 6-year follow-up period, a UK tertiary hospital observed greater biosimilar adoption than the English average after it implemented a new policy that prioritizes best-value biologics, including biosimilars, for new-start patients and those already treated with originators.

A 10-year analysis in Poland found that the introduction of biosimilar drugs significantly increased access to biologic therapies and Janus kinase (JAK) inhibitors for patients with rheumatic musculoskeletal diseases (RMDs), while also reducing treatment costs.

Here are the top 5 biosimilar articles for the week of January 22, 2024.

A Korean health agency issued Samsung Bioepis an administrative penalty related to its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives another Form 483 after the FDA reinspected its Iceland-based manufacturing facility.

A combined analysis of 3 studies found that the drug MB02 is comparable to reference bevacizumab (Avastin) in terms of its pharmacokinetics, safety, and immunogenicity.

Samsung Bioepis’ Biosimilar Market Report for the first quarter of 2024 chronicles some major market trends, including which treatment spaces have quicker uptake than others, highlighting missed opportunities for savings as well as the 1-year experience of adalimumab biosimilar competition in the US.

The FDA, Congress, biologic developers, and associations dedicated to evaluating the US biopharmaceutical space will need to work together to overcome challenges to biosimilar accessibility, says Sarfaraz K. Niazi, PhD, in his new column.

Biosimilar uptake was greater in Medicare Advantage plans when compared with traditional Medicare plans.

Authors of a review of available postapproval pharmacovigilance data assessing 8 Sandoz biosimilars concluded that these biosimilars “can be used as safely as their respective reference biologics.”

Here are the top 5 biosimilar articles for the week of January 15, 2024.

The IQVIA Institute for Human Data Science’s most recent Global Use of Medicines report projected that market introductions of new biosimilar and generic drugs will increase projected losses for originator products from $111 billion to $192 billion over the next 5 years.

As one study presented at the 2023 San Antonio Breast Cancer Symposium (SABCS) evaluated the use of circulating tumor DNA for response prediction after combination therapy with a trastuzumab biosimilar, another examined the efficacy of a pertuzumab biosimilar candidate.