Aging facilities is a trendy catchphrase that has taken hold in the biopharmaceutical industry the past few years. While most of us might think we understand intuitively what the words mean, perhaps we don’t. To that end, let’s dispel a myth right away.
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.
Aging facilities is a trendy catchphrase that has taken hold in the biopharmaceutical industry the past few years. While most of us might think we understand intuitively what the words mean, perhaps we don’t. To that end, let’s dispel a myth right away.
The convergence of data and technologies provides an opportunity for companies to make a step change in innovation and performance. Those that successfully apply the strategies to all parts of the business will thrive in an increasingly complex sector.
Biosimilars were touted as a tool for payers to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step-through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million). So what market access issues do biosimilars face in the U.S., and where could we go from here?
Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.
Continuous improvement in data integrity can advance a firm on the journey toward a mature culture of quality, particularly through the implementation of QA on the shop floor. Batch record review (BRR) and product disposition are often complicated by data integrity issues and poor data quality.
Maik W. Jornitz, President, G-CON Manufacturing LLC
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
Great hopes and expectations are linked to stem cells as a tool for drug discovery and to stem cell-derived products in therapeutic applications. Though several products have made it to commercial stage, most of the research is still performed in small scales using simple cultivation systems such as spinner flasks or T-flasks.
Vaccine development and manufacture is one of the most challenging tasks within biopharmaceuticals today.
Adenovirus vectors are effective tools for the transfer of genetic material into mammalian cells. Their qualities have led them to be the most used gene transfer vectors in experimental therapies.
The recent survey by the Economist Intelligence Unit asked biopharma execs about their hopes and concerns for the future of the industry. The results showed there was great excitement about the emergence of new markets and novel therapies, but this was tempered by worry over the complex maze of regulatory requirements. We spoke with Frithjof Holtz, Director of Advocacy and Surveillance for MilliporeSigma, to explore the interplay of emerging markets and regulatory harmonization.
Most issues in pediatric drug development arise from the fact that drugs are traditionally developed for adults and not children. Dr. Meyers shares the hurdles and improvements in pediatric drug development.
Determining suitable barrier technologies in biologics manufacturing processes with aseptic filling operations that require protecting operators from highly potent pharmaceuticals and vice versa.
