In the first part of a three-part “Ask The Board” series, members of the editorial board share what left them feeling the most heartened or concerned in 2018 and what must take center stage as we head into 2019.
According to trade groups, approximately 45 million packs of medicines leave the U.K. for Europe every month, and 37 million go in the opposite direction. In a year, that’s almost 1 billion packs of medicines. What those borders would look like after a Brexit deal would significantly impact major industries in the U.K. and EU economies.
Though it’s much too early to say for sure, we will need to watch how this formulary impacts the brand vs. biosimilar landscape, and, in turn, the performance of biosimilars in the pharmacy reimbursement space.
One employer group expert provides a good look at the current relationships between employers and those assisting them with their healthcare decisions, as well as how the Pacific Business Group on Health, has set out to create a biosimilar educational and market push initiative.
Biosimilar Development regularly discusses educational strategies and biosimilar market access strategies implemented around the world. However, one perspective that deserves more attention (on this site and elsewhere) is that of oncologists. After all, these are the experts on the front lines, experiencing manufacturers’ education strategies and influencing biosimilar uptake.
On Oct. 10, 2018, President Trump signed into law the Patient Right to Know Drug Prices Act, which, among other things, requires that certain biosimilar applicants and reference product sponsors involved in patent disputes file their settlement agreements with the FTC and the DOJ. This article summarizes the key provisions of the new law and discusses its limitations.
In addition to learning about the biosimilar-related activities National Alliance of Healthcare Purchasers Coalition has implemented recently, I picked one expert's brain about which educational strategies would best reach employers during this age when the entire U.S. healthcare system is under the microscope.
Humira is said to have recently won a national tender in the EU thanks to a startling 80 percent discount to the pre-biosimilar price tag. However, as the dust clears from the initial news, things are less clear-cut than they may have appeared.
The implementation of the Biologics Price Competition and Innovation Act1 (BPCIA) raised a number of critical issues for manufacturers, payers, and prescribers. These include the big-picture questions of extrapolation of indications, interchangeability, and a radical new approach to evaluating the comparability of these drugs to their reference biologics, as well as approving them.
Rather than focusing on whether the market has a solid basis to survive, one expert presents some interesting perspectives on the need for a more measured perspective on the market’s financial growth, as well as on the current role of biosimilar competition and differentiation.
Single-use technology is well-established, and has made its way into commercial licensed facilities, but there is more innovation in this field which will further enhance its versatility into new markets and technologies. The closed-system ballroom manufacturing approach will enable biomanufacturers to take full advantage of the flexibility offered by single-use systems, while driving out risk and is particularly suitable for applications that require multiple or rapid change-overs, and therapies with small scale production.
Strong marketing service strategies are built on a strong foundation of deeply understanding the market, customer needs, and the decision-making processes. Continue reading to learn how to elevate your organization’s credibility and service marketing plans.
The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment. Using a combination of financial options analysis and decision analytics to quantify your options helps to embrace the uncertainty equation.
The development of a robust and consistent bioprocess requires a systematic and risk-based approach to identify the right process parameters and raw materials.
Using data analytics to drive continuous improvements in efficiency.
Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property.
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