In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.

A biosimilars boom is expected and both biopharma and contract manufacturers want to be positioned to capture a piece of the market. ISR’s Biosimilars Manufacturing: Key Considerations and Expected Outsourcing Practices (4th Edition) goes into depth on one of the most important aspects of biosimilars: manufacturing.

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.

In the first segment of this two-part Q&A article, da Silva and Heller share their perspectives on the EU market potential for Humira biosimilars, which markets they expect will be most dynamic from a competition standpoint, and what Humira biosimilar players can learn from previous tumor necrosis factor (TNF) biosimilar launches.

In this first of what I expect will be several articles, I will lay out one of the current educational gaps I’ve noticed, as well as introduce real educational examples or efforts I’ve encountered (or would like to see more of) that show promising and widely adaptable pathways forward.

Low- and middle-income nations naturally demand different approaches, and, there is, of course, still much work to be done to bolster biologics use in these countries. This article continues that discussion, illuminating several specific strategies companies can explore to better reach a wide variety of countries and patients.

Though entering some of these nations will not be for the faint of heart, Iyer believes the solution to these access issues is closer than we realize.

How far have we come in raw material supply management, and what still needs accomplished to ensure the delivery of safe and effective drugs?

Despite all the FDA’s efforts to increase review time and get products to market more quickly, I remain unconvinced that the BAP will turn around the U.S. market — at least not our current market. So what can we do in the meantime?

In light of increased development and demand for biosimilars, as well as looming patent expiries, biologic developers are racing to release the next blockbuster biologic to replicate the success of past top-performers like Humira, and to prevent biosimilars from cannibalizing their market share.

In addition to laying out some of the concerning themes that came up throughout the hearing, I will unpack some of the FDA’s lines of inquiry which I feel illuminated the agency’s efforts to challenge certain claims for the first time. 

Though there’s much to write about the successes and pitfalls in the European, U.S., and Canadian biosimilar markets, it turns out there’s quite a bit that biosimilar makers need to learn about the countries off the beaten market-access path. And in many of these nations, the capacity for a biologics market already exists.

In this article I continue to outline some of the Brazil Ministry of Health's biggest questions about post-market surveillance, big data, and procurement, as these are particularly telling of how the nation’s biosimilar policy could take shape in the future.

I took the opportunity to pick editorial board member Hubert Chen's brain about the ins and outs of the 505(b)(2) pathway, which led to an even larger discussion about the critical impact a regulatory pathway can have on a company's business decisions and strategies.

This article highlights some of the early biologics industry decisions and thought processes and the subsequent actions and opportunities biosimilars create for the pharma industry.

I was recently given a first-hand look at some of the unique market-related challenges standing in the way of Brazil taking full advantage of biosimilars. In the first of this two-part article, I will provide a closer look at some of these challenges and what these may mean for the Brazilian biosimilar industry moving forward.  

This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.

Outside the world of rebate traps, product bundling, and seemingly water-tight innovator contracting efforts, there is certainly still room for biosimilar manufacturers to improve their own payer strategies. Ned Pojskic, an expert from Green Shield Canada, shares one simple solution.

Conversations about biosimilars amongst stakeholders are beginning to shift in the way that we’d like them to. The industry no longer needs to (stringently) justify the science so much as provide information on how the product can be used. One expert shares some recent revelations she plans to turn into actionable strategies in her role at Mylan and with Medicines for EU.

As biosimilars are targeting drugs with more than $5 billion in annual revenue, the originator manufacturers desperately need to find ways to either defend or replace that revenue. Strategies have included portfolio contracting, rebating, patent pursuits, supply chain differentiation, licensing deals, and building customer loyalty.

In many situations, value is associated with the price tag, and, specifically, the savings associated with a certain product. But there are still questions of how biosimilar value can be presented to stakeholders, especially since it can feel as though there is a missing part in the equation.

Complete transparency and open communication are both critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?

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.

When it comes to biosimilars, building confidence that these medicines can deliver the same experience as a branded medicine will require more than communicating successful trial results.

A number of articles already provide a synopsis of the FDA's reversal on the Statistical Approaches draft guidance. But I felt it was necessary to add one more article to this conversation, not only because this action is unprecedented thus far in the biosimilar industry, but it also suggests an important turning point in the FDA’s biosimilar oversight.

Flow cytometry introduces a powerful and versatile technology into studies, enabling in-depth analysis of cell signaling and behavior.

Mundipharma expert Richard Trollope shares his learnings from launching three different biosimilar molecules (Remsima, Truxima, and Herzuma) in the EU and discusses the questions that remain about the newly launched Herzuma, recently introduced in the U.K. and Germany.

As Pfizer began its pursuit of delivering two biosimilar mAbs in China, it sought a partner that could mitigate the risks of expanding into this region while also significantly reducing the development timeline. 

Thanks to Mundipharma's Richard Trollope, I not only got the inside scoop on what makes a biosimilar partnership specifically a biosimilar partnership, but also Mundipharma’s journey in launching Remsima, Truxima, and, most recently, Herzuma.

A recently published literature review of biosimilar switching studies drew some pushback in the form of a letter to the editor. Though this letter may seem, on the surface, another frustrating bump in the road, it raises several new, important lines of inquiry for biosimilar makers and stakeholders to explore in future publications.