Can use of the Medicare IPI achieve lower drug costs? The consensus is still out. However, it will almost certainly change the way biosimilar manufacturers will have to think about pricing their agents. And it could raise further questions about the wisdom of a biosimilar pipeline for some drug makers.
This article analyzes key indicators of pipeline strength over the past three years, including R&D spend, new chemical entity approvals, and Phase 2 and Phase 3 development.
Though the report does not focus specifically on the role of MSLs in the biosimilar space, there were a few salient points to note for biosimilar companies as they consider the evolving roles and integration of these teams.
Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.
When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.
I am not an expert on immigration or building walls. I don’t pretend that I can totally understand the political strategy of either party at the high level of the government shutdown. But as someone very familiar with the FDA, I am growing increasingly concerned that the longer the government shutdown continues — dragging the FDA along with it — the greater the potential for harm to the public health.
In this article, I share the (very) few examples of real-world evidence I found in 2018 that served as outliers compared to all the positive biosimilar data. I’ll also explore the ways RWE being released today is evolving beyond the single switching studies we’ve grown accustomed to in the past two years.
The end goal of this creative biosimilar-related work of fiction is to reflect upon and make light of the most prominent market hurdles we’ve faced thus far in the biosimilar industry.
As we enter 2019, editorial board experts share their thoughts on what challenges will be top-of-mind for biosimilar companies, trade groups, and payers, as we progress into the new year.
As the industry matures, I’m finding it harder and harder to single out one specific news headline as being the most influential. Rather, each of these Top 5 encompasses a series of events that, together, have further defined and carried this industry forward.
In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. Gain and understanding of digital biomanufacturing for upstream and downstream processes as well as the technologies that support digital manufacturing of biologics.
Advances in bioprocess monitoring and analytics, as well as in bioinformatics and computational biology, are changing the way we look at the bioproduction process. This poster explains the drivers of the digital biomanufacturing revolution and how they are steering us towards science-based increased plantwide efficiency, quality, adaptability, and profitability.
Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency - a key goal for biopharmaceutical production.
From new customer bases and vaccines to biosimilars and antibodies: what are the emerging trends and hot topics in biopharma, and how can companies take advantage of them in order to succeed?
If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed to market.
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