Skylar Jeremias

October 17, 2024

Biosimilars are safe, effective, and well-tolerated for psoriasis treatment, providing significant cost savings for the Veterans Health Administration, which saved over $67 million in 2023, while highlighting ongoing provider concerns regarding their use.

October 16, 2024

The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.

October 15, 2024

Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.

October 14, 2024

During a recent webinar, experts discussed critical regulatory aspects for generics and biosimilars, highlighting strategies for navigating complex approval processes, the importance of local market understanding, and the role of technology in enhancing submission efficiency.

October 11, 2024

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

October 11, 2024

Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.

October 10, 2024

A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.

October 09, 2024

Transformative cell and gene therapies (CGT) offer promising treatments for serious conditions, but high costs and complex biologics limit competition, requiring policies that support the development of biosimilars to enhance affordability and patient access.

October 06, 2024

On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.

October 03, 2024

The FDA approved a new strength of a trastuzumab biosimilar; UnitedHealth will remove reference adalimumab from some preferred drug lists in favor of biosimilars and Evernorth will offer an interchangeable ustekinumab biosimilar at no cost to patients; Samsung Bioepis received a positive regulatory opinion for its aflibercept biosimilar.