From The Editor | January 3, 2019

Biosimilar Experts Pinpoint 2019's Biggest Industry Challenges

Anna Rose Welch Headshot

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

biosimilar industry

Prior to the holidays, I reached out to the trusted members of Biosimilar Development’s editorial board for their thoughts on 2018’s biosimilar triumphs and tribulations, as well as what’s to come in 2019. Just because it’s a brand-new year doesn’t mean the industry will be faced with any fewer challenges. Rather, as these experts point out in the final installment of this three-part Q&A series, the industry is facing several critical inflection points in terms of business strategies and market development. Encouraging sophisticated educational efforts, partnerships, and policy objectives will remain front-and-center throughout 2019. As we enter 2019, these 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.     

What will be the single biggest challenge biosimilar companies will run into in 2019, and why do you think this? Are there any specific strategies you think the industry could use to address these challenges?


As biosimilars become available in the U.S., it is important that they are seamlessly integrated into the healthcare system. This will require acceptance by many stakeholders, including individual patients and patient advocacy groups, as well as healthcare providers and their professional associations. Pharmacy and hospital systems as well as payers and distributors will need to modify their systems appropriately in order to ensure smooth delivery of biosimilars to patients. Progress in this direction has already been made, but more growth is still needed to get biosimilars to the point where they are used without lingering questions and without systemic technical barriers.

          — Hillel Cohen, executive director, scientific affairs, Sandoz


I believe one of the biggest challenges will be at the strategic level. Will each player stick with biosimilars for the long-haul? Will they develop the rigorous and robust long-term plans needed, from pre-selection to post-launch? Will they decide not only to be in it, but also to do everything needed comprehensively to win it, not only from development to regulatory affairs, but also in-depth commercialization analysis and planning, policy, and government affairs?  

We could in fact see 2019 becoming an inflection point for the industry in a variety of ways. It could be the year where some of the most significant barriers to successful uptake of biosimilars are not just identified but are actually meaningfully addressed. It could also be the year that we see companies drop out of the space, such as we recently saw with Momenta, allowing the same pie for fewer players.

Those that decide to remain must keep in mind that biosimilars are not an analog or incremental game, but, rather, are quite digital in nature. You can’t chip away at biosimilars; you can’t step in gingerly, wait for things to happen and develop, take a few steps back when challenges are faced, and then try to sprint forward as they appear to resolve. Biosimilars require rigor, planning, and all-in commitment to succeed. Of course, there can be variations in such things as different value propositions and even different business or operating models come to light. But, either way, biosimilars are a big bet. And those companies poised with true differentiation, long-term commitment, and the rigorous planning and insights needed to ensure agility and excellence in execution will be rewarded handsomely.   

          — Edric Engert, managing director, Abraxeolus Consulting


The single biggest challenge that companies will run into is convincing stakeholders (providers, insurance companies, employers, patient groups, policy makers, etc.) that we are at an inflection point of whether the biosimilars market in the U.S. is seen as a success or a failure. Actions taken by U.S. health care stakeholders in 2019 will send signals back to companies as to whether or not it is important to continue investing in the development of biosimilars. Negative signals and new or continuing barriers will affect whether we realize the future promise of improved savings for the healthcare system and increased patient access in the U.S.

To some extent, the industry can address this challenge by continuing to educate stakeholders on the current state of the biosimilars market and actions that can be taken by each of them to help support its long-term success.

 — Brian Lehman, MBA, MHA, RPh., director, medical account management and strategic alliances, Sandoz


The most challenging question will be how companies position themselves in a market that is becoming more crowded. Differentiation from other biosimilars, as well as from the originator, without stepping over the boundary of biosimilarity will be the most important aspect in the future. This means biosimilars should have an added value for patients and additional clinical studies should be performed to prove these benefits. Depending on the market, price reduction alone will certainly not be sufficient to gain enough market share.

We also see a clear trend as originator companies are starting to protect themselves against biosimilar competition by introducing innovation into their products, such as improved formulations and medical devices.

Celltrion Healthcare is looking forward to launching subcutaneous infliximab next year. We expect that this will generate further cost savings in addition to improved convenience as dual formulations would provide personalized therapeutic approaches to optimize patient outcomes.

          — HoUng Kim, head of strategy and operations, Celltrion


The gap between the number of approved biosimilar products vs. the number of commercialized/profitable products, at least in the U.S., will not narrow for the foreseeable future. This, unfortunately, has had a disproportionate impact on smaller-sized biosimilar companies, which need to convince their investors to remain patient, particularly when greater returns appear more likely in novel biologics research and development. It is possible that the concept of an independent “pure-play” biosimilar company will soon become a historical curiosity.

          — Hubert Chen, medical and scientific advisor, Pfenex


The biggest challenge will likely be to reconcile health policy objectives and the reality of the market today, but also in the mid-term based on all the facts and trends we know.   

As an industry representative body, we ought to intensify our connecting role between policy makers, healthcare stakeholders, and the operational actors of the industry for collective solutions to emerge from the cumulated experience. Understanding this may mean tailoring approaches to one or other national, regional, or local systems.

          — Julie Maréchal-Jamil, director, biosimilars policy & science, Medicines for Europe


The single biggest challenge in the U.S. will be getting market access and growing market shares in 2019. It may be that 2019 proves to be a little unpredictable as the political administration continues to look for ways to address drug pricing. Whilst everyone agrees this topic is critical, it is also difficult for companies to plan for what is to come when this is unknown. Accessing the U.S. market for biologics will remain challenging given the patent thickets and the consequent delays to launch although products have been approved by FDA. With 15 biosimilars approved and only 6 launched, the barriers to market entry remain.

— Sue Naeyaert, global government affairs, policy, and pharmacoeconomics, biosimilars, Fresenius Kabi


The major challenge for the biosimilar industry will be sustainability, facing potential price erosion, and consequential risks for operations in lower-margin markets. This is a challenge that could be mitigated by applying a more holistic approach to marketing by increasing the weight of scientific and regulatory data in marketing strategies. Biosimilars are not biogenerics, hence they require extensive and specific development programs and communication to market stakeholders.

          — Ruediger Jankowsky, managing director, Cinfa Biotech


The biggest challenges biosimilar manufacturers will face are the ongoing patent and regulatory issues, which continue to impact commercialization plans. To address these issues, biosimilar manufacturers need to strengthen their planning processes and support more activity ahead of a product’s launch — all of which a partner can help with.

Pre-launch, manufacturers will want to educate thoroughly all major stakeholders — payers, providers, wholesalers, etc. — on the safety and efficacy of their products. Wholesalers can help with this process by working with their own customers to establish greater lines of communication, inclusive of feedback loops, between manufacturers and sites of care.

From the wholesaler perspective, it is important to partner with manufacturers that are working towards the same long-term goals, such as strengthening the biosimilar platform and ensuring it remains viable for access and affordability. Together, we can support the longevity of biosimilars.

 — Rick Lozano, VP, biosimilars and integrated business development, AmerisourceBergen


The single biggest challenge continues to be competition from originator products on the contracting and pricing side of the equation. With deals on originator products continuing to dominate the private payer market, biosimilar manufacturers have struggled to gain significant traction on this side of the market. There appears to be continuing activity to re-negotiate some of these private payer contracts to dissuade payers from engaging in biosimilar-first strategies.

          — Ned Pojskic, leader, pharmacy & health provider relations, Green Shield Canada