By Anna Rose Welch, Editor, Biosimilar Development
Follow Me On Twitter @AnnaRoseWelch
A few weeks ago, I invaded Pfizer’s headquarters to sit in on a press conference with five Pfizer Essential Health (PEH) executives in the biosimilar business. The night before the meeting (after buying every poetry book in The Strand), I wracked my brain for the best question to ask each expert. But of the many I could ask, I found myself drawn to one relatively simple question: what have you been most surprised or challenged by while working in the biosimilar industry, and how has this impacted your thoughts on moving Pfizer’s biosimilar business forward?
As a writer in this space, I often live vicariously through the experts I meet and interview (and my readers too). You are all employed by a wide array of companies, which boast different business models, pipelines, goals, and strategies to bring biosimilars to the market. Some of you work alongside biosimilar companies and are responsible for supporting a biosimilar at different stages of its development and at different points in the supply chain. I’ve been writing in the biosimilar space for almost three years, and to say I’ve learned a lot would be a vast understatement. As such, I can only imagine what it’s like for those of you who have been involved in this business — or in other aspects of the pharmaceutical industry — for even longer.
PEH, in particular, intrigued me because of the balancing act many Big Pharma companies have had to maintain; these companies have both an innovator and biosimilar pipelines. In today’s often fraught biosimilar landscape (especially in terms of IP and payer contracting), the way companies walk both sides of the line has always been a source of fascination to me. I had always assumed jumping into the biosimilar ring may seem as natural as breathing to larger companies with the talent, resources, and experience they’ve amassed in the biologics market.
But after hearing the five experts share their answers to my question, it turns out it takes more to enter the biosimilar business than simply being a leading innovator in the biologics space. As the experts shared, there are some integral transitions, both in mindset and in terms of practice, that need to occur to fully embrace biosimilars.
Brand To Biosimilar: A Natural Transition … After Some Thought
One reason I was particularly excited to meet with the PEH executives was because of Pfizer’s clear support of the biosimilar market. The company has faced a number of hurdles in terms of launching its pipeline and getting Inflectra reimbursed. But I also found it refreshing that a company stressing its innovative roots has also proven its dedication to helping the biosimilar industry succeed by challenging certain innovator contracting methods. And I think this gumption has to do with the experts’ perceptions of how biosimilars actually do tie into and support a brand.
Several of these experts are fairly new in the PEH biosimilar business, including PEH’s Group President Angela Hwang who, most recently, was the head of Pfizer’s inflammation and immunology business unit. She came to her current position with experience in supporting brand biologics, including Enbrel, which Pfizer markets outside of North America. As such, she spent her time promoting a brand and working to increase access to it. When you work to support a brand, she said, “You begin to look at how important that brand is and just how many patients are on it. When it’s been on the market for 30 years, there’s the notion that the brand needs to prevail. The question I always used to ask myself was, ‘what more can we do to drive the brand?’”
But she found this question evolving as she observed the use of biologics around the world and witnessed the advent of biosimilars in the EU. A wide array of behaviors and systemic approaches determine how a patient can access and receive a drug. In turn, many patients aren’t able to access biologic treatments at all.
“While I was in a role trying to drive the branded biologic, what I actually saw was the need for an alternative because it was the only way patients would have access to the wide range of biologics on the market today,” Hwang shared.
Accessibility has been particularly stressed in the biosimilar space as the industry works to define biosimilar value outside of price and cost. In fact, the term came up so frequently at a conference I attended last fall, I decided to make it one of the “mottos” of the biosimilar space, coupled with “education, education, education,” “data” (x3), and “collaboration”(x3).
Overall, the concept that biosimilars are a tool to bolster the overall biologics experience was woven throughout the conversation during my visit to Pfizer headquarters. Naturally, there have been challenges associated with being a leader in the space; the extent of exclusionary pricing, for instance, was not fully anticipated. But, Richard Blackburn, global president of the EU, Africa, Middle East, and biosimilars at PEH, said, watching the uptake of infliximab (Remsima/Inflectra) grow across Europe has inspired greater confidence and enthusiasm internally for the biosimilar mission.
“With each new biosimilar that has been launched in Europe, we’ve been seeing faster uptake, which tells us that, generally, the physician and patient community is getting used to the idea of biosimilars and their confidence is growing,” Blackburn said. “I think that confidence has been mirrored within Pfizer. There’s greater comfort that a company like Pfizer can be successful both as the provider of originator biologics and of biosimilars.”
Competitive Differentiation: An Evolving Concept
As Amrit Ray, global president of R&D for PEH, shared, Pfizer’s reputation in the biologics space precedes itself. In entering the biosimilar market, the company has relied on the technology platforms and the clinical development and regulatory expertise that helped the company develop biologics for the past 30 years. But as Ray and I discussed following the conference, if I had spoken to him five years ago, he might have assumed the company was fully prepared with these assets to tackle biosimilars. In reality, the company has had to make some important updates to its capabilities.
For one, “In addition to using the other technologies we’ve established in our broader biologics portfolio, we have looked into using gene expression technologies to construct new Pfizer cell lines that can produce biosimilars at commercial scale,” he explained. “We’ve also built analytical labs that can scale up from pilot to commercial scale rapidly.”
In my discussions with experts throughout the years, a term that has surfaced time and time again is “agility.” There are a number of areas in which biosimilar companies need to be agile, whether it be working with a commercialization partner in different markets, entering growing markets, or establishing a sound supply chain.
Working to speed development and better meet demand in an evolving market is a challenge impacting the biologics space as a whole. But because demand for biosimilars is so varied (depending on the nation), Ray said a biosimilar maker’s focus needs to be on the capabilities that will enable a quick scale-up. “We need to ask ourselves, ‘How many patients would we treat in a week?’”
In this industry, companies cannot take competitive differentiation too lightly. For some, this means coming up with a new device or formulation to better compete against the innovator and other biosimilar makers. For others, it means establishing new regulatory strategies (with the help of regulators) that cut down on the amount of clinical work needed is certainly another. Ray sees an important differentiator in the ability to look ahead at the combined investments needed to fit the biosimilar landscape — not just the biologics market.
“What’s become apparent to me is that the experience, the scientific capability, and the technical sophistication, in totality, are a competitive differentiator,” he said. “I think this also fills us with confidence that we’re fully prepared to contribute to the biosimilar space and to patients.”