With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilar medications may offer is intriguing to many policymakers as well as those in the industry.
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?"
Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.
With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilar medications may offer is intriguing to many policymakers as well as those in the industry.
The previous article in our "Identifying And Resolving Errors, Defects, And Problems Within Your Organization" series focused on identifying manufacturing trends so you can know when to act and when to let your processes run without interference. This one discusses what needs to happen when a defect or nonconformance is detected and needs to be investigated, explaining one of the most broadly applicable and durable root cause analysis tools: the fishbone diagram.
Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. If anything, the problems will tend to multiply as transnational clandestine operations continue to be involved in the highly lucrative counterfeit drug market. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.
Seeking early guidance from regulators can be invaluable when navigating preliminary product development strategies. The need for feedback increases significantly when working with cell and gene therapy products (CT/GT). These therapies, once considered a kind of “wild-west,” are becoming more widely accepted. Still, the task of seeking approval from the FDA can be extremely challenging. It’s become vital to get your relationship with the FDA off to a solid start from day one.
In the global biosimilars industry, regulations are administered locally, on a country-by-country basis, inevitably leading to inefficiencies and contradictions in regulatory requirements for biosimilar approval from one country to the next. If those inefficiencies are too great, some companies may delay or forego entirely seeking approval in a jurisdiction where the costs or uncertainties of the regulatory path are too high.
This white paper delves into the best practices involved in managing chemical inventory to achieve the most effective, holistic chemical inventory system.
This white paper, brought to you by Dassault Systèmes BIOVIA, discusses the different types of external collaborations research organizations engage in, the reasons that many of these partnerships fail to meet expectations, and an informatics solutions to overcome these issues.
Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing.
Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits. In some ways, will cell and gene therapy manufacturing be similar to biopharmaceutical manufacturing? What are the key differences and gaps in learning?
Drug substance characterization is critical to drug product formulation but characterization and formulation are often not integrated during drug development.
Understand the analytical challenges faced when implementing the BPOG protocol for four SUS components.
There are a number of factors to be taken into consideration when selecting containers for use within a critical environment.
