Stakeholders Weigh In on the Key Biosimilar Developments of 2018

2018 was an eventful year for the biosimilars marketplace. We asked experts from across stakeholder groups—and from the United States and abroad—what they felt were the most notable moments in biosimilars during 2018, and what they hope the new year holds for this developing industry.

Marcus Snow, MD, assistant professor of rheumatology, University of Nebraska

“I think that from the viewpoint of a rheumatologist, the biggest development is what has not happened. The availability of biosimilars for most rheumatologists continues to be limited. The combined effect of legal issues, pharmacy benefit managers, and formulary restrictions have made biosimilars available only to a small minority of practicing rheumatologists.”

Hear more from Marcus Snow.

Joseph P. Fuhr, Jr, PhD, professor emeritus, Widener University

“Biosimilars are the grand experiment. If biosimilar competition does not work, it may result in price controls which would decrease the incentive to innovate and lead to fewer new drugs being developed.

In an EU country there has been an 80% decrease in the price of Humira in a tender case. This is good in the short run, but such large decreases may discourage future entry into the biosimilar market. In the United States, there are 7 biosimilar settlements concerning AbbVie's Humira, with entry not occurring until 2023. This increases uncertainty because it is unknown what this market will look like in 2023.

These 2 developments, as well as others, lead to the issue of whether firms will be able to obtain a return on investment in the biosimilar market which could lead to fewer or no entries in the long run.”

Hear more from Joseph Fuhr.

Ha Kung Wong, JD, partner at Venable

“Regarding developments this year, the most interesting from a legal perspective was the United States Supreme Court’s decision in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, on April 24, 2018, holding that the inter partes review (IPR) procedure does not violate Article 3 of the Constitution. Thus, IPRs are still a viable route for challenging a patent.

According to Biologics HQ, all challenged claims are found unpatentable in 67% of IPR Final Written Decisions concerning biologic products. So you can understand how this is incredibly important to biosimilars companies, as it provides a significant route for challenging patents that may pose infringement concerns in advance of potentially engaging with the convoluted ‘patent dance’ detailed in the Biologics Price Competition and Innovation Act.

As for the future, one case that biologics and biosimilars companies should keep an eye on is Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc., case number 17-1229, currently before the United States Supreme Court, where the scope of the on-sale bar after the America Invents Act (AIA) is at issue.

The on-sale bar holds that sales of an invention that occur more than a year before a patent application is filed are prior art that can be used to invalidate a patent. Importantly, the on-sale bar is in play even if these sales are confidential and no details of the invention are disclosed. However, many believe that the AIA has narrowed the on-sale bar so that it is in play only when the public sales actually disclose the details of the invention. This decision will be particularly interesting since it not only concerns legal precedence, but also aspects of legislative history and intent of the AIA.

For biologics and biosimilar products, this decision can significantly impact how they conduct business, and when they seek patent protection for various aspects of their product. Will the Supreme Court put us in line with other countries by narrowing the on-sale bar, or will it stick with history?

We should find out soon, as the case was argued before the Supreme Court on December 4, 2018.”

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation

“Despite the FDA continuing its approval of biosimilar medications, few are actually available to physicians and their patients because innovator companies are using the patent law and the courts to slow their introduction. However, in 2018, progress was made when AbbVie settled with everyone except Boehringer-Ingelheim to bring a Humira biosimilar to market in 2023.

What’s needed next is better access to biosimilars, and for a while, there were rumors about biosimilar safety and efficacy. Those rumors were dispelled in 2018. They are as safe and efficacious as biologics.”

Hear more from Seth Ginsberg.

Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development for Vizient

“The Biosimilar Action Plan and the number of approved biosimilars (16) are 2 encouraging aspects of 2018, especially for those of us who have been part of this discussion for a long time. It signals that progress for biosimilars continues, even though it has not been as fast as desired. For 2019, it is all about oncology biosimilars and if the experiences with supportive care and biologic DMARDs will pave the way for success in this new area of practice.”

Read more from Steven Lucio.

Julie Maréchal-Jamil, director of biosimilar policy and science at Medicines for Europe

“From an EU perspective, I will not select as ‘most notable development’ the big bang of adalimumab biosimilar medicines’ simultaneous entry on the market.

I believe a less broadcasted yet most notable development is the marketing authorization of biosimilars for pegfilgrastim. To me, this marks a significant advance in the overall assessment and authorization process whereby the regulators demonstrate that analytical comparability is a very powerful and invaluable tool to demonstrate sameness, and that it can outperform any comparability clinical trial.

This has far-reaching implications for future biosimilar candidates and their developments: science and experience support a fitter-for-purpose approach to comparability which could translate in faster development timelines and reduced development investments, for uncompromised patient outcomes. Quite a program!

From an international perspective, I’d say the US FDA launching its Biosimilar Action Plan is likely to be, for me, a stepping stone. It crystalizes a number of critical issues for the good functioning of the US market, but it is also a signal that regulators alone won’t fix the complexity of market entry and that competition cannot be expected, or assumed, but that a real infrastructure and framework are needed for competition to unleash the full potential of biologic medicines.

In 2019, I do wish to witness an assertive pushback from regulatory agencies on the persistent misleading information on biosimilars. Experience is pretty much all there is to say; regulators can rely on their process which consistently delivers versions of biologic medicines that behave as expected (ie, as the originator).

This is extremely important to ascertain the foundation of the biosimilar medicine’s existence; however, it will unfortunately fall short of ensuring that biosimilar medicines can deliver on their promise of access. In the EU, it will be essential to see concrete policy framework changes: late biosimilar adopters will need to act and implement features fostering competition among biologic medicines producers (eg, benefit-sharing systems to incentivize the use of the best-value biologic medicine available). Early biosimilar adopters, on the other hand, will have to reflect on how to make the current health care benefits last (eg, adapting procurement mechanisms) and biosimilar medicines portfolios continue to expand.”

Read more from Julie Maréchal-Jamil.