The Top 5 Biosimilar Articles for the Week of January 6

Number 5: The top 5 biosimilar-related articles of the year highlight a significant shift in the pharmaceutical industry, with projections indicating strong uptake in biosimilars at the expense of the originator products, despite challenges like uptake disparities and safety concerns.

Number 4: The 2024 surge in FDA approvals for aflibercept biosimilars reflects significant progress in offering cost-effective treatments for retinal conditions like neovascular age-related macular degeneration, although patent disputes pose challenges to their market entry and adoption.

Number 3: The phase 3 trial showed biosimilar CT-P42 (Celltrion) is therapeutically equivalent to reference aflibercept in improving visual acuity in patients with diabetic macular edema (DME), with comparable efficacy, safety, pharmacokinetics, and immunogenicity at 24 weeks, with more long-term data expected.

Number 2: To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.

Number 1: Sarfaraz K. Niazi argues that the Indian Central Drugs Standard Control Organisation (CDSCO) Biosimilar Guidelines need revision to align with current scientific understanding and focus on better manufacturing practices.

To read all of these articles and more, visit centerforbiosimilars.com.