While biosimilar manufacturers face many unique challenges in patent litigation, one of the most common is an infringement action brought under the doctrine of equivalents (DOE). DOE is a principle where a party sues for infringing on the general spirit of the patent, rather than on the specific content of its claims.
I reached out to Biosimilar Development editorial board member Molly Burich of Boehringer Ingelheim for her input on the policies she expects could have the largest positive or negative impact on biosimilars, as well as what progress has been made on the policy front.
With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilars may offer is intriguing to many policymakers as well as those in the industry.
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.
There are many challenges to walk through to truly understand the opportunity, the risks, and the best path forward for biosimilars, but the best thing would be to start by recognizing the external and internal risks that likely every player in the space is facing.
One of the regulatory inefficiencies the FDA is trying to address is the current requirement for bridging studies to submit data comparing a biosimilar to a non-U.S. licensed product.
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 biosimilars. This article discusses two significant elements of the BAP.
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.
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