Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone else is exhibiting a form of the psychological bias known as the bandwagon effect, in which they go along with the rhetoric because everyone else is.
Though there is a large handful of countries that, to date, don’t have biosimilar pathways established, a few countries have been slowly gearing up to be leaders in paving the way for biologics and biosimilars. In this article, I’ll discuss the potential of these three markets, as well as the business considerations Challand highlighted for companies considering entering the MENA region.
Throughout her presentation, Challand gave us a good look at the current state of the biologics market in MENA and the ongoing educational and collaborative efforts that could help shape the markets in this region. She also shared several important considerations for regulators and biosimilar companies looking to expand their business to MENA.
Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.
I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.
Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.
Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone else is exhibiting a form of the psychological bias known as the bandwagon effect, in which they go along with the rhetoric because everyone else is.
One of the most intriguing experiences we have had in our business in the last 20 years is being faced with a seemingly simple water-soluble topical or device component fill and then being told it is an organic peroxide! When we in our nice, safe water-based business (leave out liposomes) are faced with the compounding fire/electrical/OSHA compliances along with our GMP issues, it starts to read like a 1940s detective mystery.
Since the introduction of similar biological medicinal products in the EU in 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the United States. How does the rise of the China biosimilars market fit into this established picture?
CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.
ASTM standard E2500, Specification, Design, and Verification of Pharma and Biopharma Manufacturing Systems and Equipment, elevates risk-based validation as a critical aspect of GMP manufacturing. This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective
Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).
The wide range of antibody fragment variants for which Amsphere A3 can be used as a capture resin is described, together with insight to the related binding mechanisms obtained via x-ray crystallography.
Degraded samples are common and certainly problematic for investigators. Read more about common causes of degradation as well as agents and systems available to protect against freeze–thaw.
The potential for antibody-drug conjugate (ADC) programs to accelerate from early to late stage clinical development highlights the need to establish commercial launch-ready manufacturing early and efficiently.
With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.
Gain an understanding of exosomes which are recently attracting attentions of researchers as new mediators of cell-cell communication transporting biomolecules such as lipids, proteins, and RNAs in vivo.
When it comes to downstream bioprocessing, we already have many of the technologies we require – we only need to focus on adapting them.
