Prescription drug spending increases — fueled by high launch prices for new therapies and price increases for existing brand-name drugs — are contributing to unsustainable healthcare cost growth across the country. In addition to straining the healthcare system overall, high drug prices also place financial burdens on patients who rely on prescription medicines to treat and manage serious and chronic medical conditions.
How do we act on the data of previous 483s? What do we do with that data? Similar to the annual product reviews, we gather data on FDA observations, make graphs, and then … file it away. But there is an alternative.
The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.
In recent years, the growth in U.S. drug spending has become a hot-button issue. Data released in 2017 by the pharmacy benefit manager (PBM) Express Scripts illustrates which drugs account for the increased spending. In 2016, spend on so-called specialty drugs, a class that contains many biologics, grew by over 13 percent, while spend on traditional drugs actually declined by 1 percent. Five of the top 10 earning drug therapies in the U.S. in 2016 were biologics.
In the first part of this two-part article, we touched on the two strategies for distributing biosimilars. In this article, Lozano highlights some of the common topics that pose the greatest challenges for manufacturers, in particular pricing their products and establishing patient and provider services.
As more real-world evidence demonstrating biosimilars’ efficacy and safety is released, I daresay I speak for many in the U.S. who are left asking, “What more do we need?” Well, this event turned me on to a few areas that could use some work and renewed attention.
In the past two years, nine biosimilars have been approved by the FDA, three for use in cancer patients and six for use in patients with inflammatory arthritis and inflammatory bowel diseases.
It’s rare that I should stumble upon an article discussing how biosimilars actually end up at the hospital or pharmacy in the first place. So I took the opportunity to speak with AmerisourceBergen's Richard Lozano to get a better sense of the manufacturer-wholesaler relationship and some of the questions companies must consider as they prepare to supply their biosimilars to the market.
Brexit — and the looming fear of it — appeared on a number of pharmaceutical industry recap articles and columns for 2017, as well as ones looking forward into 2018, with many describing it as the most important factor affecting the industry in the next few years. As with all trends, someone will choose to swim against the tide and make the argument against conventional reasoning.
Mergers and acquisitions (M&As) are commonplace across the healthcare landscape. Such consolidation is intended to drive efficiencies and spur growth. Traditionally, such M&A activity has involved horizontal integration — the marriage of similar types of organizations (i.e., a pharmaceutical company and a biotech; a national insurance provider with a regional player). The desired merger of CVS and Aetna, however, introduces a dramatically different dynamic — the vertical integration of two different types of businesses, a pharmacy/drug distribution entity and an insurance company, to create a new type of healthcare system. How will such a new entity impact biosimilar use?
Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.
Leverage this resource to accelerate biologic manufacturing of mAbs, vaccines, and novel biotherapies.
This application note describes how to achieve accurate comparability assessments using Biacore™ T200 and Amersham™ WB system in the development of a biosimilar.
It is hoped that the development of biosimilars will lead to more competition, and therefore, more accessible, cost-effective treatments.
Bioprocessing development is a long and costly process. Building in continuous characterization and connected bioprocessing cuts timelines and increases the available information through real-time analytics.
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