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.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
Enhanced flexibility and reduced operating costs are being achieved through the widespread adoption of single-use technology either as part of completely single-use processes or as hybrid solutions.
Through a successful implementation, Fujifilm was able to not only recognize the benefits an integrated automation platform offers but also the importance of working with an experienced partner.
In development of all pharma production processes, including hMAbs produced by CHO cells, decisions regarding the best parameters and methods are made based on cost, time, and titer comparisons.
How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time to market.
Understand the new technologies and methodologies that are emerging for both producing and testing biopharmaceuticals as the industry is entering a new era of viral safety assurance.
A company has to be able to withstand the highs and lows of biologics development. To avoid costly mistakes and wasted efforts, a company must prepare for surprises along the drug development pathway.
