Biologics

Biologic Prescribers Want USP Excluded from Product Naming

Six groups representing biologic prescribers have sent a letter to the Senate Health, Education, Labor and Pensions (HELP) Committee leadership commending the bipartisan sponsorship of Section 11 of S. 2700, a provision of the 21st Century Cures Act, that assures full FDA authority over the identity (name) and quality standards for biologic products, including biosimilars. Historically, the United States Pharmacopeia (USP) has been responsible for the official nomenclature and common quality standards of small-molecule drugs, however due to biologic complexity of large-molecule drugs, Section 11 would ensure FDA obtains the authority over biologics and biosimilars.

The letter acknowledges that the agency has worked to establish the appropriate regulatory framework for what is likely to be a $50-100 billion market in biosimilars.“FDA has proceeded cautiously, declaring that it will make decisions on a case-by-case basis until it has the knowledge to impose a comprehensive regulatory framework for the approval and safe use of biosimilars,” it says.

“Now,” the letter continues, “after considerable, specialized work and the approval of two biosimilars, the agency feels ready to propose, and soon finalize, guidance that will set the course for biosimilars. Potentially interfering with this biologics-based approach is the traditional, small-molecule drug role granted to official compendia, specifically that of the (USP), to define the official nomenclature and common quality standards. This involvement of the USP has made sense for small molecule drug products. However, it is not appropriate for biosimilars, where each product relies on a unique cell line and manufacturing process and requires unique specifications. Section 11 will ensure that FDA sets biosimilars policy, not USP.”

The letter was signed by: Alliance for Patient Access, American Association of Clinical Endocrinologists, American College of Rheumatology, Biologics Prescribers Collaborative, Coalition of State Rheumatology Organizations, and Endocrine Society.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome