How often do you hear pharma companies (your company?) pride themselves with trite phrases like “our people are our differentiating factor.” Sounds good. Yet the reality in the trenches is far from this panacea — most industry talent reports refer to disgruntled staff who are poorly managed and organized into factions that are out for their own discrete success.
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.
How often do you hear pharma companies (your company?) pride themselves with trite phrases like “our people are our differentiating factor.” Sounds good. Yet the reality in the trenches is far from this panacea — most industry talent reports refer to disgruntled staff who are poorly managed and organized into factions that are out for their own discrete success.
Real-world evidence (RWE) has become increasingly important for innovative manufacturers looking to convince reluctant payers that their new medicine has a place in patient care. Indeed, many claim the changing nature of the data landscape in healthcare will revolutionize the way we consider evidence, but does this apply to biosimilars? Is there a real need to look at data from actual clinical practice before or after market entry for these products?
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.
The complexity of drug product supply chains has increased in recent years thanks mainly to the development of more complex chemical molecules and reduced average production volumes.
Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.
This article explains how using an Octet-based Fc receptor panel may help developers achieve a faster assessment of monoclonal antibody functionality, well before the final molecule is selected.
whether you’re building a plant for a small molecule drug or a biologic, you need to be able to do so faster and in a more agile manner than ever before.
This articles provides some fundamental tips and tricks to preparative chromatography that will yield a pure sample preparation that will advance protein characterization studies.
Collaboration takes many forms; this article will look at how document production, distribution and archiving are affected by the virtual pharma model and in clinical and manufacturing quality settings.
In the recent Economist Intelligence Unit survey on biopharma’s present and future, biopharma industry leaders expressed excitement and some uncertainty about the emerging markets of the Middle East and Africa. Respondents saw great opportunity in these regions, but also cited potential risks in relation to regulatory questions and stability issues. We spoke with Bert de Vet, Head of Commercial EMEA Process Solutions at MilliporeSigma, about his take on growth in the region and some of the ways companies entering these regions can mitigate risk.
