While the biosimilar market in the U.S. has gotten off to a relatively slow start compared to Europe, where biosimilars have been available since 2006, it has recently gained momentum and will continue to grow in the coming years as more “blockbuster” biologics lose regulatory exclusivity and patent protection. Here we review our observations in the biosimilar space since the enactment of the 2009 Biologics Price Competition and Innovation Act (BPCIA) and our view of the future of biosimilars and related patent disputes.
Last month, the FDA published the draft guidance “Principles of Premarket Pathways for Combination Products.” The document describes what a combination product is and how to interact with the FDA when developing a combination product, and it identifies some of the principles the agency uses in determining what type of premarket submission should be made.
A variety of stakeholders including the FDA, Congress, hospitals, and consumers are in agreement — biosimilars have not penetrated the market as expected. By our count, 18 biosimilars have been approved by the FDA since the passage of the Biologics Price Competition and Innovation Act (BPCIA), but only seven have come to market. Over the past year, a number of governmental bodies have focused on this issue and how to remedy it.
The FDA issued the first warning letter citing failure to comply with requirements of the November 2013 Drug Supply Chain Security Act (DSCSA) amendments to the Food, Drug, and Cosmetic (FD&C) Act. This warning letter was issued to McKesson Corporation in San Francisco on February 7, 2019.
We often work with organizations adding capacity, transferring new products, and adding existing products from other sites into their “preferred” plants. These facilities range from CMOs to traditional name-brand pharmaceutical companies. In each case, the receiving site is focused on schedule and budget, and these competing targets have often distracted personnel.
The biosimilars pipeline is progressing rapidly and continues to grow, with more products and more organizations involved. This article reviews the current biosimilars development pipeline and progress.
It was the announcement many have been dreading — but expecting — for several months now. Dr. Scott Gottlieb, 23rd Commissioner of the FDA, announced his decision to step down after 663 days (22 months) on the job. The news is sure to raise concerns for many. But I think the biggest surprise is how equally sad thought-leaders within the agency will be to say goodbye.
The requirements of the Drug Supply Chain Security Act continue to progress as planned. The next milestone the industry needs to be cognizant of is the Nov. 27, 2019 requirement that wholesale distributors verify the product identifier on each unit returned for the distributor to be allowed to resell the product.
SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome with the aid of a skilled facilitator.
Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.
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