GlaxoSmithKline’s (GSK’s) blockbuster Advair (salmeterol/fluticasone) is a long-acting beta2 agonist/inhaled corticosteroid fixed-dose combination (LABA/ICS FDC) therapy used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Advair is one of GSK’s best-performing drugs, garnering more than $2 billion in company-reported U.S. sales in 2017, despite intense competition from other LABA/ICS FDC brands.
Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.
There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"
Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.
These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.
Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.
GlaxoSmithKline’s (GSK’s) blockbuster Advair (salmeterol/fluticasone) is a long-acting beta2 agonist/inhaled corticosteroid fixed-dose combination (LABA/ICS FDC) therapy used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Advair is one of GSK’s best-performing drugs, garnering more than $2 billion in company-reported U.S. sales in 2017, despite intense competition from other LABA/ICS FDC brands.
The commissioning of a facility, equipment, or system for operation under GMP regulations involves qualification that all operations are suitable for the intended purpose. The facility owner must have traceable verification of the systems, minimizing punchlist items to improve start-up and eliminate problems up front.
This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.
FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.
This article emphasizes the importance of implementing a regular routine maintenance for inductively coupled plasma mass spectrometry (ICP-MS) equipment, so problem areas associated with instrumental components that are most susceptible to sample blockage, drift, and signal instability can be avoided.
How outsourcing and technologies such as in-line conditioning (IC) and in-line dilution (ILD) can help prevent resource constraints, save time, and reduce manufacturing footprint and overall cost in buffer preparation.
In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.
The success of biologics for use in humans depends on the ability to effectively remove any viral contaminants. Viral Clearance from biologics is critical to their performance since they can directly infect mammalian cells and cause diseases such as AIDS, mumps, measles, herpes, hepatitis, meningitis, and shingles. And, conversely, studying these disease causing viruses can aid in the development of preventive and curative therapeutics. In this article, Bio-Rad provides snapshots of the different apatite-based media that can be effectively utilized for the process-scale purification of small to mid-sized viruses.
Inaccurate demand forecasts can have significant implications for companies developing biologics. And, it is increasingly difficult to locate capacity to respond to demand changes.
While protein purification is a well-established, conventional and highly trusted discipline, the approaches it employs can be as diverse as its targets.
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.
The traditional CMO business model, with multiple clients sharing the same tightly scheduled production trains, is not adaptive; it is a one-size-fits-all solution.
