The ultimate success of gene and cell therapy products relies on the seamless delivery of a potent drug product to patients. The pharmaceutical supply chain is inherently complex; however, gene therapies face additional roadblocks such as ever-changing regulatory compliance, chain of custody due to the personalized nature of autologous therapies, patient demand, and scalability from clinical to commercial. Moreover, the complexity of the delivery process is exacerbated by the temperature- and time-sensitive nature of immunotherapy products.
Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.
I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.
Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"
The ultimate success of gene and cell therapy products relies on the seamless delivery of a potent drug product to patients. The pharmaceutical supply chain is inherently complex; however, gene therapies face additional roadblocks such as ever-changing regulatory compliance, chain of custody due to the personalized nature of autologous therapies, patient demand, and scalability from clinical to commercial. Moreover, the complexity of the delivery process is exacerbated by the temperature- and time-sensitive nature of immunotherapy products.
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 DSCSA amendments to the FD&C Act. This article takes a close look at this warning letter, but first it examines why McKesson may have received the first warning letter in this category, and explains why pharmaceutical manufacturers should care and what precautions they should take.
As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms.
With so many connection options, it can often be an overwhelming task to decide which connector is best suited for a specific application. By understanding your application requirements and selecting the correct connection type, you will have better performance and sealing results. By Colder Products Company
A thorough and systematic process to holistically gauge the attributes of a firm that are critical to creating an effective outsourcing relationship.
The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.
An individual that knows the product and processes from start to finish having performed the tasks at each stage gives the client reassurance and the CMO retains a valuable employee by avoiding burnout or loss of focus.
The opportunities in developing global markets appear limitless, but the obstacles surrounding them can be daunting. With issues ranging from language barriers to protecting intellectual property rights, each solution must be as unique as the country the work is developed in. Download this eBook to learn key strategies to unlock foreign pharma markets.
Currently, there is a transformation taking place that will pave the way for even more changes to how the industry approaches drug manufacturing.
