Drugs

Steps to Expedite Biosimilar Market Entry: Petition

The University of Illinois at Chicago College of Pharmacy says there are steps FDA could take to expedite entry of biosimilars into U.S. markets. In a 5/11 petition, the school says that since passage of the Biologics Price Competition and Innovation Act in 2009, FDA has licensed only nine products. “The slow entrance of biosimilars into the U.S. market, along with a cost of $150+ million and 7-8 years into development are untenable and need addressing and appropriate changes made … to benefit American patients,” the petition says. Specific actions requested to allow faster development and licensing of biosimilar products involve FDA:

modifying the current default status of requiring bridging studies between a U.S.-licensed product and a non-U.S. approved comparator, to establish biosimilarity;
presenting clear and open scientific views to the public, and especially to prescribers, that a biosimilar product has “no clinically meaningful difference” from the original comparator product and thus it should be acceptable for naïve patients, without getting involved with the legality of substitution;
encouraging development of in vitro immunogenicity testing methods to reduce exposure of test subjects on ethical grounds;
revising some of the specific statistical testing methodologies in establishing analytical similarity to remove certain contradictions in the guidance; and
taking a fresh look at the clinical relevance of the protocols and statistical methods used to establish PK/PD similarity, to make these studies more clinically relevant while reducing study cost.

“Immediate action by the agency will bring instant relief to U.S. customers at a reduced cost of biosimilars,” the petition concludes.

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