This is the second article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding Biosimilars Price Competition and Innovation Act district court litigation and reviewed ongoing BPCIA district court cases. In Part 2, we turn our attention to BPCIA district court cases that were settled in 2019.

In many ways, last year was a notable one for biosimilars in the U.S. During the 2019 calendar year, the FDA approved the 26th biosimilar product, and the 12th biosimilar product was launched in the U.S. market (with more expected to launch in the coming weeks).

I had the fortune of talking with two U.S. Sandoz executives, Sheila Frame, VP, marketing, market access, and patient services, and William Yoon, head, external engagement and medical advocacy. In the first of this two-part article, I picked their brains about the progress they’ve observed and how challenges for the industry have evolved over the past 10 years.

Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.

Following the news of Fresenius Kabi’s new biosimilar R&D lab, I reached out to one executive to discuss the current challenges in biosimilar R&D, including maintaining the delicate balance between biosimilar R&D and commercial teams as Fresenius Kabi prepares for a long future in the biosimilar space.

I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through. So, you’re getting a whopping seven this year.

As we face 2020, several big questions remain from the past year and about what the future may (or may not) bring for the industry. Here, these 19 experts pose their biggest questions for the new year, as well as how they anticipate or hope these questions could be answered.

The industry has shown surprising resilience and consistency, emerging relatively unscathed from the recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and a recession-resistant risk profile.

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.

Challenges exist when developing biologic drugs to be efficacious but safe. 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.