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.
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?"
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.
One of the major challenges in batch mammalian cell clarification is cost-effective improvement in filtration in the face of high cell densities.
To help meet the needs of both large- and small-scale operations, suppliers of sterilizing-grade filters have developed new products and technologies to help meet the needs of today’s biomanufacturing processes. Industry trends toward intensified processing and increased implementation of single-use systems are changing approaches to sterile filtration and bioburden control in biomanufacturing processes.
As the need for smaller plants, flexible manufacturing and competition intensifies in the biopharma industry, so does the need for intensified processes
Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success.
Companies must understand how today’s new pharmaceutical landscape is causing a dramatic shift in how we plan for and execute drug development and manufacturing.
Understand the analytical challenges faced when implementing the BPOG protocol for four SUS components.
Whether these proteins are produced by recombinant DNA technology or extracted from sources such as plasma, they need to be highly purified — and the purification process must satisfy a variety of regulations.
