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.
Genderless sterile connectors — with their ability to interconnect with each other without male/female limitations — can enhance the flexibility of single-use systems in a range of bioprocessing applications.
The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.
Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving pharma to improve product and process quality and efficiency.
In development of all pharma production processes, including hMAbs produced by CHO cells, decisions regarding the best parameters and methods are made based on cost, time, and titer comparisons.
Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.
As the recent Economist Intelligence Unit survey showed, Asia remains an important region for biopharma, with some notable trends appearing for the next five years. We spoke about these findings with MilliporeSigma’s Julien Zhao (Biosimilar and Emerging Biotech Markets Manager, Asia) and MS Mahadevan (Head of Actives and Formulations, Asia Pacific) to hear their take on Asian market evolution, crossborder collaboration, and why countries like Indonesia might just be the future of the industry.
As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way.
