Drugs

FDA Biosimilar Bioanalytical ‘Best Practices’ Coming

FDA says it will develop bioanalytical “best practices” for biosimilar biological product development. Writing in the recent American Association of Pharmaceutical Scientists Journal, a team of CDER officials said they examined 28 biosimilar biologic license applications that had been submitted up to 12/2018, which showed a “diversity of the bioanalytical approaches used, as well as the observed differences in bioanalytical bias.”

The CDER article notes that developing and validating a bioanalytical method for biosimilar biological product development (BPD) can be challenging. “It requires the development of a bioanalytical method that reliably and accurately measures both proposed biosimilar and reference products in a biological matrix,” they write. “Our findings highlight the need for understanding the critical aspects of BPD bioanalysis and clarifyingBPD bioanalytical best practices, which could help ensure consistent method validation approaches in the BPD community.”

The authors write that the enzyme-linked immunosorbent assay (ELISA) remains the most frequently-used platform in BPD, probably because of the technology’s simplicity. They also found that most reagents were commercially sourced. “While the use of commercial reagents may allow for consistent use of method formats across various [contract research organizations) for proposed biosimilar products with the same mechanisms of action, bioanalytical laboratories can benefit from understanding the reagent quality and lot-to-lot variability,” they write. “On the other hand, custom-made reagents may provide additional benefits, as these are known for specificity and selectivity for the products being measured. Thus, it may be beneficial for bioanalytical laboratories to qualify and manage the life cycles of critical reagents and include critical reagent information in method validation reports, since sources and types of reagents utilized in bioanalytical methods may also impact method performance and reproducibility.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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