The Many Gray Areas Of Biosimilar Commercialization

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

When I took the helm of Biosimilar Development, I was charged with the admittedly daunting task of figuring out what members of the biosimilar industry would want to read. For those of you who are regular readers, you’ve likely noted this publication covers many aspects of the biologics manufacturing process, as well as clinical development challenges for biosimilars. But the topic that seems to get the most attention in the biosimilar space — at least so far — is commercialization.

When I’ve spoken with industry members, they’ve expressed an interest in learning what companies are doing to compete in the market. This sought-after knowledge could encompass anything from how a company is approaching interchangeability, education, or partnerships to establish its biosimilar as a leader in the space. But after hearing from several executives at the GPhA Biosimilars Council Leading on Biosimilars conference earlier this fall, it’s become even more clear there is no black and white path to commercial success in this industry.

How Important Will Interchangeability Be For Biosimilars?

It’s been difficult to get a handle on just how influential interchangeability will be for biosimilar uptake. Part of this is because we’re still missing the FDA’s guidance on interchangeability — a critical piece of the puzzle. But when it comes down to it, there are few unified opinions on how important this designation will be for biosimilar uptake. I’ve heard economics will be the primary impetus for uptake, rather than interchangeability. Then, there are those who believe interchangeability will be a game changer. I’ve also heard that interchangeability could be a leg-up for a few players, but it will all depend on what evidence the FDA demands from drugmakers. There are concerns that too many requirements from the FDA could eliminate the incentive to pursue the designation at all.

To be fair, interchangeability isn’t devoid of competitive allure. For one, the first biosimilar earning the interchangeable designation is granted an exclusivity period. Similarly, the designation itself suggests the biosimilar has attained a higher level of quality or similarity than the other biosimilars on the market, which can give a company a competitive edge. (Though, to clarify, interchangeability doesn’t mean the molecule itself is more similar or of a higher quality than a non-interchangeable biosimilar).

But for Craig Wheeler, the president and CEO of Momenta, his emphasis on the designation has changed throughout Momenta’s tenure in the biosimilar market. As Wheeler pointed out, there are success stories throughout Europe and enough pricing pressures in the U.S. to ensure that biosimilars, regardless of interchangeability, will be broadly accepted. The status might prove beneficial for a company that is one of the first on the market while the innovator is still being widely prescribed. “But if you come late to the market, just being interchangeable won’t help you much,” said Wheeler. “Interchangeability won’t be the be-all and end-all to create a competitive advantage.”  

Similarly, as Apobiologix President Steve Lydeamore pointed out, your pipeline will be an important predictor of the importance of interchangeability. For instance, if your pipeline is centered around hematology and oncology products, which are hospital-administered, “Interchangeability is occurring already, even without the designation,” Lydeamore acknowledged. “I don’t think an interchangeable status would make that much difference in the hospital. It will depend on price.”

Though from a company’s standpoint interchangeability might not be the silver bullet to successfully compete, there are other stakeholder opinions to take into account — for instance, patients and providers. Peter Goldschmidt, the president of Sandoz U.S. and head of North America for Sandoz, drew attention to the importance of interchangeability to these stakeholders. “You should always look at interchangeability from a patient perspective,” Goldschmidt argued. Even though interchangeability doesn’t mean a biosimilar is of higher quality than a non-interchangeable biosimilar, this designation could offer reassurance of safety and efficacy to patients, especially in the early stages of uptake.

Marketing Muscle & Sales Forces: Core Biosimilar Competencies?

I’ve heard a number of stories about the key role Sandoz’s sales force played in the uptake of its biosimilar, Omnitrope, in Europe. At the GPhA conference, Goldschmidt continued to emphasize the important role of the sales force in educating stakeholders as the market unfolds in the U.S. Like interchangeability, however, the importance of a sales force remains a gray area.  

Six months prior to the launch of Zarxio, Sandoz directed its sales force to go into the market and educate about what biosimilars are and how biosimilarity is determined. For physicians, this information was important because biosimilars did (and still do) present a different clinical development and approval process to wrap their heads around compared to innovator drugs.

But “There’s a lot more to bringing a biosimilar product successfully to market than just analytics and molecular similarity,” said Goldschmidt. For instance, payers and providers also had questions about reimbursement frameworks, health systems, group purchasing organizations, and individual buy-ins.

Biosimilar uptake is a tricky animal. Physician trust will not be the only factor granting a biosimilar company the biggest portion of the market. There are also payers, hospitals, and pharmacy practices to keep in mind. But, according to Goldschmidt, a big key to securing market share is “to be out there.” Sandoz had the benefit (and challenge) of being first to the EU with Omnitrope and first in the U.S. with Zarxio. “If you’re first to the market, you have to educate,” Goldschmidt admitted. “For Zarxio, we found we needed a sales force to do this.”  

But this raises the question of how important marketing and sales competency will remain as more competitors are launched in the U.S. As stakeholders become more educated about biosimilars, this could call into question the importance of the sales force. Similarly, as more competitors arrive on the market, price competition, rather than an active sales force, will be a larger determiner of a company’s market share.

Momenta’s Wheeler argued patient services will be the area that demands large marketing muscles. After all, there is growing pressure for biosimilar companies to understand and meet patient needs in order to challenge innovator companies’ established patient programs for the reference drugs. But he doesn’t expect a large biosimilar sales force will be a key competitive advantage five to 10 years down the line.

“It’s naïve for us to think that physicians aren’t acutely aware of the economic challenges their patients are facing,” Wheeler said. “They’re going to use biosimilars.”

What Will Improve Success, Regardless Of Company Size?

One unanswered question I’ve asked myself is if a company’s size will matter in this particular market. On one hand, Wheeler argued a company’s size does matter when developing patient services and when operating on a global level — all key aspects of building a strong presence in the biosimilar space. 

But to Bert Liang, CEO of Pfenex, the goal of a biosimilar maker is to compete against the targeted reference product. As Liang articulated, “Regardless of whether it’s a Sandoz or a Pfenex, the question is how can we compete to the best of our own technology?” Overall, a company’s ability to negotiate prices and rebates, as well as payers’ and purchasers’ desires to lower drug costs will, in the end, matter more than “the heft of a very large organization,” said Liang.

After hearing these perspectives, it’s clear a biosimilar company must have the same capabilities as a leading brand or generics maker. As such, several members of the panel emphasized the allure of partnerships in this space, especially given the importance of next-generation technologies and flexible manufacturing to determining a biosimilar maker’s competitive advantage.

Similarly, regardless of a company’s size, supply reliability should always be considered. Companies partnering with a wholesaler or an insurance company to launch a biosimilar must be able to prove they have the supply reliability to provide for the large U.S. market. Just because a company may have experience providing a biosimilar to several smaller markets in Europe, for instance, does not mean it will have the ability to extend its supply to a nation as large as the U.S.  As such, it will be important for all companies partnering up to discuss how they will provide larger quantities of the biosimilar, Goldschmidt articulated.

The biosimilar industry as a whole is up against a yet uncertain biosimilar commercial model. Pharmaceutical benefit managers (PBMs) face the decision of whether to treat biosimilars as generics or brand drugs or to create a third model. (You can guarantee the PBM will be considering its own profitability when making this business decision, just like any other company.)   

Whether it be a small or large company in an established partnership or flying solo, every company needs to be sensitive to changes that might arise as the market marches onward. Wheeler put it best when he said, “We have to ask where the market is going and when we will need to break from tradition and think about different models for some of our products.”