This is the first in a series of articles on Six Sigma that will introduce you to this methodical, rigorous approach to process excellence, and share the author's experiences using the technique in the pharmaceutical industry.
In the last few weeks, news stories have surfaced reminding the biosimilar industry that biobetters are alive and, for the most part, well. Overall, there are upwards of 500 biobetters in development worldwide. But should the biosimilar industry really be concerned about biobetters quashing the use of biosimilars?
Following the recent Amgen and Sandoz FDA advisory committee meetings, which focused heavily on concerns about “non-medical switching,” Dr. Steiner Madsen’s often frank discussion on how switching contributed to biosimilar uptake in Norway provides reassurance and best practices for global biosimilar makers.
A recently published article in The Wall Street Journal proposes several changes to the FDA approval process. However, at a time when there should be more emphasis on accelerating biosimilar approval, this proposal very well could spell trouble for biosimilars.
Though both FDA advisory committees unanimously recommended approval and extrapolation of both Amgen's and Sandoz's biosimilars, this process was not as cut-and-dried as expected following the overwhelmingly positive FDA briefing documents. The stumbling points of each committee are important to note prior to your own candidates' FDA submission.
In recent weeks, the U.K. made the seismic decision to leave the E.U. But biosimilars aren’t without support. Prior to Brexit, the U.K. celebrated the launch of the BBA, which has several initiatives underway to keep biosimilars a priority in the newly independent country.
This is the first in a series of articles on Six Sigma that will introduce you to this methodical, rigorous approach to process excellence, and share the author's experiences using the technique in the pharmaceutical industry.
The idea of thinking in terms of “operational excellence” is a relatively new idea for the biopharmaceutical industry. The enormous uncertainty associated with bringing a biological drug product from discovery to approval almost precludes the thought of forward-thinking in terms of what makes a quality product, especially during early-stage development. However, extensive product knowledge is gathered during early development, and crucial decisions are made in terms moving the science forward to generate the data required to meet your business objectives.
The recent introduction in Europe of biosimilar anti-tumor necrosis factor (anti-TNF) drugs has attracted considerable attention. Much of the commentary to date has centered on price, but price tells only part of the story. Structural and perceptual differences have led to considerable heterogeneity in the levels of discounting, access, and uptake throughout and even within European markets.
In recent years, we have witnessed a meteoric rise in clinical studies of cancer immunotherapies, catapulting immuno-oncology into one of the fastest growing and dynamic areas in pharmaceutical development today.
Combination products represent a remarkable opportunity to extend the potential patient population for biologics and improve the delivery of drug therapies. This is one of the most dynamic segments in the life sciences , projected to grow to $115 billion by 2019.
The Consumer Packaged Goods (CPG) Industry relies on continuous product innovation to introduce successful new products and drive business growth.
The pipeline of biopharmaceutical drugs is rich and becoming increasingly diverse. Many new biologic modalities are being developed as established therapeutic classes move through their lifecycle. Wide arrays of different types of molecules are expected to coexist within product portfolios and manufacturing networks. It is clear that this will have a significant impact on manufacturing facilities. Strategies need to be developed to prepare facilities for these challenges.
A recent survey by the Economist Intelligence Unit questioned biopharma industry leaders about their plans and concerns for the future. Along with excitement over expanding into novel therapies and emerging markets, they expressed serious concerns about risk mitigation. To combat risk, they raised the potentially contradictory options of building internal capacity and using outside experts. We spoke with Sebastien Ribault – Director of the MilliporeSigma BioDevelopment Center – to get his take on this duality and how it’s changing the nature of partnership.
Label content pertaining to non-prescription healthcare products is of great concern to the government of Canada. Not only what appears on the label but also the wording, how it appears and how easy it is to understand are all of vital concern.
The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.
The success of any biologic drug, for example, monoclonal antibodies (mAbs), recombinant proteins, or biosimilars, depends greatly on downstream purification. Among the challenges process scientists often face during this process is the formation and/or removal of aggregates of monomers.
15,937 industry leaders, 40% of which were C-level executives, attended the BIO International Convention in San Francisco that ran June 6-9. The MilliporeSigma team used this opportune gathering of the biopharma industry to unveil the findings of a study that it recently sponsored with The Economist Intelligence Unit, titled The Changing Biopharma Risk Equation.
