Merck’s recent announcement that its infliximab biosimilar, Renflexis, was awarded a U.S. Department of Veterans Affairs (VA) national contract has sparked curiosity about the potential influence this might have on biosimilar adoption and formulary preference in the rest of the market. Renflexis was determined to be the lowest-priced infliximab proposed under a competitive solicitation and, as such, was awarded preferred use as the only infliximab option covered on the VA National Formulary (VANF).
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.
During our conversation, Kokino and I walked through the steps Mylan took to establish this foundation, as well as how the company’s overseas biosimilar experiences influenced its global — including the U.S. — biosimilar launch strategy.
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.
The ultimate goal of the biopharmaceutical industry is to ensure a consistent supply of safe and effective drugs to patients who need them. One key factor in doing so is to address the challenges of raw material sourcing and management.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.
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