Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.
After roughly four years of writing about biosimilars, I can finally say I attended the Annual Biosimilar Medicines Conference. This conference was valuable to get a closer look at Europe as well, not only to see where things are working, but also where they're not.
As we see more real-world evidence (RWE) released in the gastroenterology community, I wanted to learn how one patient advocacy organization is approaching biosimilar education, what challenges the organization is facing, and how the industry and FDA can better reach patients and physicians.
Last week, I had the pleasure of chairing the first day of the BioTech Pharma Summit: Biologics and Biosimilars conference in the gorgeous Porto, Portugal. (Don’t ask me how much I spent I spent on port wine in the days before the conference.) The conference was — shockingly — the first European biosimilar conference I have attended in my tenure as a biosimilars editor. (Even though Europe is leaps and bounds — and then more bounds — ahead of the U.S. with biosimilars.)
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.
Validating host cell protein ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE approach combines the best of existing methods.
Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.
At the CBI Biosimilars Summit in January, I had the pleasure of moderating a panel comprising three experts, including Jesse Peterson, clinical development manager at Fairview Specialty Pharmacy. The topic of conversation was stakeholder education, which Peterson is well-equipped to speak about, given his position at regional specialty pharmacy. In his role, Peterson works with experts across the pharmacy operations team and manages relationships with the health system’s payer partners and manufacturers. He is responsible for sharing updates on the future of the specialty pipeline internally and with payers, as well as identifying areas where potential savings could be realized.
A few months ago, I read a fabulous Q&A in Managed Care Magazine featuring oncologist Gary Lyman and co-director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center. In this day and age, we regularly come across surveys or discussions emphasizing how much more work we have to do in the education realm to ensure physicians’ comfort with biosimilars. But after reading Lyman’s interview on one cold, dreary January day, I felt buoyed. That’s not to say there isn’t more work to be done, of course. But it was reassuring to see a prominent member of the oncology community express such comfort and confidence in biosimilars.
In the first of what will be two articles, I walk you through a high-level model forecast Engert shared to demonstrate that the value-capture possible after developing a biosimilar is much higher than what we may assume. In order to receive these rewards, however, there are five steps Engert outlines that a company must take to properly manage the risks that arise.
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.
Just as the FDA emphasized that companies should take a “step-wise” approach to biosimilar development, I’d argue this same approach needs to be embraced in our commercialization and education efforts moving forward.
From new customer bases and vaccines to biosimilars and antibodies: what are the emerging trends and hot topics in biopharma, and how can companies take advantage of them in order to succeed?
If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed to market.
Though the report does not focus specifically on the role of MSLs in the biosimilar space, there were a few salient points to note for biosimilar companies as they consider the evolving roles and integration of these teams.
When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.
The end goal of this creative biosimilar-related work of fiction is to reflect upon and make light of the most prominent market hurdles we’ve faced thus far in the biosimilar industry.
As we enter 2019, editorial board experts share their thoughts on what challenges will be top-of-mind for biosimilar companies, trade groups, and payers, as we progress into the new year.
As the industry matures, I’m finding it harder and harder to single out one specific news headline as being the most influential. Rather, each of these Top 5 encompasses a series of events that, together, have further defined and carried this industry forward.
Using what The Coalition’s President and CEO Troy Ross has termed “3D thinking” through the creation of data mapping, employers are gaining access to information they’ve never been privy to before that will enable them to identify savings opportunities and better design their benefits — which could mean increased traction for biosimilars.
In the second of this three-part "Ask the Board" series, Biosimilar Development's editorial board members discuss their predictions on how biosimilar development, market access, commercialization efforts, and regulatory and reimbursement policies will evolve in 2019.
In the first part of a three-part “Ask The Board” series, members of the editorial board share what left them feeling the most heartened or concerned in 2018 and what must take center stage as we head into 2019.
In lieu of the slow development of the U.S. biosimilar market, the FDA has stepped up to determine how it can improve biosimilar education, regulation, and market access. As many of the industry comments to the Biosimilar Action Plan revealed, this will require the FDA to continue broadening its purview and refining the regulatory pathway by implementing several specific actions.
In this article, I’ll discuss the importance of one commonly overlooked expert and highlight one recent educational initiative that exemplifies current needs in biosimilar communication strategies.
One employer group expert provides a good look at the current relationships between employers and those assisting them with their healthcare decisions, as well as how the Pacific Business Group on Health, has set out to create a biosimilar educational and market push initiative.
Biosimilar Development regularly discusses educational strategies and biosimilar market access strategies implemented around the world. However, one perspective that deserves more attention (on this site and elsewhere) is that of oncologists. After all, these are the experts on the front lines, experiencing manufacturers’ education strategies and influencing biosimilar uptake.
In addition to learning about the biosimilar-related activities National Alliance of Healthcare Purchasers Coalition has implemented recently, I picked one expert's brain about which educational strategies would best reach employers during this age when the entire U.S. healthcare system is under the microscope.
Humira is said to have recently won a national tender in the EU thanks to a startling 80 percent discount to the pre-biosimilar price tag. However, as the dust clears from the initial news, things are less clear-cut than they may have appeared.
Rather than focusing on whether the market has a solid basis to survive, one expert presents some interesting perspectives on the need for a more measured perspective on the market’s financial growth, as well as on the current role of biosimilar competition and differentiation.
During our conversation, Kokino and I walked through the steps Mylan took to establish this foundation, as well as how the company’s overseas biosimilar experiences influenced its global — including the U.S. — biosimilar launch strategy.