FDA Policy/General

FDA Accepts Accord’s Herceptin Biosimilar BLA

FDA has accepted for review an Accord BioPharma BLA for HLX02, a proposed trastuzumab (Roche’s Herceptin) biosimilar for adjuvant treatment of HER2-overexpressing breast cancer, the treatment of HER2-overexpressing metastatic breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The submission, according to Accord, is based on “robust structural and functional analytical comparison data using multiple orthogonal techniques and head-to-head clinical studies between HLX02 and the reference trastuzumab, including comparative analytical studies, nonclinical studies, a Phase 1 PK similarity study and a global multicentric phase 3 safety, efficacy and immunogenicity study in relevant patient populations, which compared HLX02 to the reference trastuzumab.” Data reportedly demonstrated that HLX02 and reference trastuzumab are similar in quality, safety, and efficacy.

HLX02 was first developed by Accord’s China-based business partner Shanghai Henlius. In 2021, Henlius granted Accord BioPharma the exclusive rights to develop and commercialize HLX02 in the U.S. and Canada.

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