The Center for Biosimilars® recaps the top 5 articles for the week of August 6, 2018.
Transcript:
Hi, I’m Samantha DiGrande for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilars articles for the week of August 6.
Number 5: Stada recently announced that it is increasing its presence in the biosimilar sphere by becoming the majority shareholder in Bioceuticals, a venture capital-funded organization created by Stada to carry out its biosimilar programs.
Number 4: Full results of a 30-week study of Pfizer’s biosimilar infliximab, Ixifi, in patients with rheumatoid arthritis show the product has similar efficacy to Remicade, with or without dose escalation.
Number 3: The United Kingdom has proposed extending price controls to biosimilars. The measures require brand-name drug makers to pay the government 7.8% of their sales of products to the National Health Service.
Number 2: The Initiative for Medicines, Access, and Knowledge has issued a new report that calls out drug makers for securing large numbers of patents—and raising prices—on high-cost drugs.
Number 1: Celltrion’s troubled manufacturing plant is the subject of yet another FDA Form 483.
Finally, last week, our e-newsletter asked whether Congress should pass newly introduced legislation requiring innovator and biosimilar sponsors to disclose the terms of agreements that delay biosimilar market entry.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
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Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
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November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.