In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.
In the first segment of this two-part Q&A article, da Silva and Heller share their perspectives on the EU market potential for Humira biosimilars, which markets they expect will be most dynamic from a competition standpoint, and what Humira biosimilar players can learn from previous tumor necrosis factor (TNF) biosimilar launches.
In July 2018, the FDA unveiled a Biosimilar Action Plan (BAP) intended to “facilitate the efficient development and approval” of biosimilar products. When FDA Commissioner Scott Gottlieb introduced the BAP, he emphasized the importance of building a market for biosimilar products and expressed concern that the market is not yet established.
In this first of what I expect will be several articles, I will lay out one of the current educational gaps I’ve noticed, as well as introduce real educational examples or efforts I’ve encountered (or would like to see more of) that show promising and widely adaptable pathways forward.
Low- and middle-income nations naturally demand different approaches, and, there is, of course, still much work to be done to bolster biologics use in these countries. This article continues that discussion, illuminating several specific strategies companies can explore to better reach a wide variety of countries and patients.
Though entering some of these nations will not be for the faint of heart, Iyer believes the solution to these access issues is closer than we realize.
A decade after the primary negotiations that resulted in the Biologics Price Competition and Innovation Act (BPCIA), it is safe to say the promise of biosimilars is yet to be realized. And as it turns out, perhaps naivety, in a clinical sense, is the solution.
Despite all the FDA’s efforts to increase review time and get products to market more quickly, I remain unconvinced that the BAP will turn around the U.S. market — at least not our current market. So what can we do in the meantime?
In light of increased development and demand for biosimilars, as well as looming patent expiries, biologic developers are racing to release the next blockbuster biologic to replicate the success of past top-performers like Humira, and to prevent biosimilars from cannibalizing their market share.
In addition to laying out some of the concerning themes that came up throughout the hearing, I will unpack some of the FDA’s lines of inquiry which I feel illuminated the agency’s efforts to challenge certain claims for the first time.
Fast and efficient process development and scale-up contributes to a shortened time to market. This application note demonstrates a multidimensional scale-up (change of both column diameter and bed height) of a mAb capture step, using the ÄKTA pilot 600 chromatography system.
Calculation examples that highlight scenarios where the enhanced capacity and alkaline‑stability of MabSelect PrismA can provide process economic benefits to large‑scale mAb processing.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
This application note examines these aspects of using sodium hydroxide as a cleaning and sanitizing agent.
A demonstration of the long‑term chromatographic performance of MabSelect PrismA during repeated purification cycles using 0.5 M NaOH for CIP.
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