Skylar Jeremias

January 29, 2024

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.

January 28, 2024

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.

January 25, 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.

January 23, 2024

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.

January 18, 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.

January 17, 2024

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.

January 16, 2024

A study examining biosimilar uptake patterns within different health insurance plans found that low-flexibility plans, such as health maintenance organizations and exclusive provider organizations, were more likely to initiate biosimilar therapies than more flexible plans.

January 15, 2024

The FDA has approved Coherus Biosciences’ on-body injector version of Udenyca (pegfilgrastim-cbqv), making it the first biosimilar to reference Neulasta Onpro, the pegfilgrastim product that holds the majority of the pegfilgrastim market share.

January 14, 2024

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.

January 11, 2024

As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.