As we close out another year of global biosimilar successes and twists and turns, it’s always important to take stock on just how far we have come and where we still hope to go as an industry. As in years past, I reached out to members of Biosimilar Development’s editorial board and several other experts to get their take on the past year's progress.

Overall, there are three broad takeaways to both celebrate and consider about the FDA’s latest clarification of the biosimilar regulatory pathway as it relates to insulin biosimilars.

Here, IQVIA’s Jaclyn Bosco, Sandoz’s Edward Li, and the University of Messina’s Dr. Gianluca Trifirò discuss how RWE can impact regulator and payer decisions, shape treatment pathways, and encourage greater stakeholder comfort and action toward biosimilars.

Though these experts all believe this transition should go off without a hitch and will not hinder insulin access, there are several overarching regulatory and educational considerations the industry should be aware of as March continues to creep closer.

In addition to discussing past challenges, two experts from NeuClone shared insights into the critical analytical, manufacturing, and clinical considerations that are important to make for any company — but especially for smaller companies — when developing biosimilars.   

One EMA regulator brought up several points at a recent conference that stood out, either as bright spots to boost industry morale, or that emphasized where the industry needs to focus its energy to pave the way for future regulatory reform.

Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

Sometimes your size exclusion chromatography (SEC) results don’t look like you want them to. Fix issues like poor resolution, peak tailing and fronting with the tips in this FAQ.

Need to find out how to calibrate your size exclusion chromatography (SEC) column? Or how different additives affect your results? Read these useful insights.

Size exclusion chromatography (SEC) is the go-to analytical method in the analysis of therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

Droplet Digital PCR (ddPCR) enables easy multiplexing of numerous targets within each fluorescent channel. Amplitude-based multiplexing achieves this by varying primer and/or probe concentrations. In probe-mixing multiplexing, probes are mixed at desired concentrations to place targets in a defined position on a 2-D plot. This paper describes strategies for both approaches using the large portfolio of ddPCR Assays readily available through Bio‑Rad.

Most CML cases are caused by a translocation between chromosomes 9 and 22 that creates an abnormal fusion gene, BCR-ABL1. This poster explains how Bio-Rad’s QXDx™ BCR-ABL %IS Kit quantifies the amount of BCR-ABL1 transcript as a ratio of BCR-ABL1/ABL1, then returns the value of Molecular Response (MR) and on the WHO International Scale(IS). The QXDx software performs automatic data analysis and reporting, results are reported in %IS, MR, and copies values.

Increasingly, scientists are being challenged to study more biologically-relevant model systems, and this often means imaging thick, demanding 3D samples that may also be alive. Read how IRIS and EDGE confocal imaging can offer high contrast imaging of thicker samples.

Artificial intelligence (AI) provides exciting opportunities for fast, accurate, and unbiased cell image analysis. Read this guide to machine learning in high content analysis and see the benefits AI can bring to your automated cell imaging.

While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

Overall, arguments calling into question the value of biologics competition tie into what I think is an even more important question worth asking in this country: What global responsibility does the U.S., as the largest pharmaceutical market, have in terms of promoting greater access to medicines?

The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.

This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.

Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

Rob Wright takes issue with Peter Bach, M.D., and Mark Trusheim’s recommendation that the U.S. would be better served by abandoning continued biosimilar drug development.

Saurabh Kapure, Vice President, Business Development, USA for Jubilant Biosys, recently sat down with Michael Gallatin, Ph.D., president and co-founder of Mavupharma (Mavu), the drug discovery and development company, to discuss some of the latest developments in the industry and at Mavu. In this Q&A, Dr. Gallatin shares his thoughts about Mavupharma, his role at the company, the evolution of biopharma, drug discovery, development, and the road ahead for the industry with Saurabh.

In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.

During our discussion, I learned more about this patient organization and its biosimilar education goals, as well as what type of information could be particularly helpful for the breast cancer patient community at this point in time.

Free collection of articles highlighting some of the dynamics playing out in the hospital setting for biosimilars, as well as how physicians and drugmakers can foster a greater understanding of biosimilar medicines.

Not only are the issues impacting cell and gene therapies relatable on the biosimilar side, I’m hoping this particular strategy can inspire creative thinking as scrutiny into the buy-and-bill landscape continues to intensify.

Because negative news and opinions seem to create greater waves, I thought I would take stock of the positive news that may not have come over your desks or (more realistically) cellphones in the past few weeks. While it’s easy to get bogged down by negative speculation, there’s progress being made and companies and experts fighting daily to keep this industry moving forward, even if it feels glacial.

Achieving “smarter”, more flexible workflows requires a complete understanding of today’s novel solutions and technologies, which, when applied appropriately, can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry. 

With a newer toolbox of options to intensify downstream manufacturing operations, it is important to understand what factors should impact decisions regarding the implementation of these solutions.

Meeting the goals of today’s industry requires a deeper look at how to continuously achieve maximum utilization and reduce waste without sacrificing quality in the race to be first to market. 

Breaking down the implementation of continuous manufacturing into the following four steps may provide some much-needed guidance as you prepare your network for the future of biomanufacturing.