From The Editor | December 18, 2018

What Biosimilar Metamorphoses Are In Store For 2019?

ARW Edit Headshot 2

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

biosimilar industry

In the first installment of the annual Biosimilar Development editorial board “Ask The Board” series, the experts shared which events in 2018 supported or changed their ideas about the biosimilar market’s progress. Now, in the second article of the series, they share their thoughts on how one or several of the broad biosimilar development focus areas will be shaped in 2019. Here, the discussion embraces everything from needs for different commercial strategies to price transparency, streamlined regulations, and, of course, more education. Enjoy this latest installment and stay tuned after the new year for the editorial board’s insights into the biggest 2019 challenges awaiting us!   

How do you predict each of the following will change in 2019 in the realms of: a.) biosimilar development; b.) market access; c.) commercialization efforts; d.) regulatory policies; and/or e.) reimbursement/government policy? Why do you feel that way? 


In 2019, I predict leading pro-biosimilar manufacturers will continue their day-to-day efforts to educate stakeholders on the value that biosimilars can bring in enhancing patient care and well-being, as well as to dispel any false or misleading information being disseminated about safety or efficacy. It will remain critical that patients and providers grow confidence for biosimilars and not become skeptical.  

The FDA will support these manufacturers by continuing to develop and roll out effective communications to improve understanding of biosimilars among patients, clinicians, and payors as part of their Biosimilar Action Plan efforts. Additionally, the FDA will implement efforts to maximize scientific and regulatory clarity, as well as improve the efficiency of development and approval. 

I am cautiously optimistic that stakeholders, such as providers, patients, policy makers, insurance companies, and employers will continue to grow in their level of support for biosimilars and work towards removing many of the barriers that exist. For example, pharmacists who are the trusted medication experts in the health care system may play a growing role in providing clarity to patients and providers about the facts vs. myths about biosimilars in order to increase confidence in these medicines.

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


2019 will likely continue to see growing acceptance of biosimilars in Canada, particularly from the physician perspective. With about 4 years of experience with bisimilars in the Canadian market, most physicians have had the opportunity to gain familiarity with the these products and observe their clinical benefits.

2019 will also likely usher in an era of biosimilar transitioning at a provincial policy level. There has been no published information on the timing of these policies but momentum does appear to be behind stronger transitioning policies in various jurisdictions in the country.

           —Ned Pojskic, Leader, Pharmacy & Health Provider Relations, Green Shield Canada


In terms of biosimilar development, I predict there will be more focus paid to second-world markets. However, we’ll likely see increased market penetration in the U.S., thanks to the continued education of patients on the efficacy and value of biosimilars that will increase demand for these lower-cost alternatives.

            —Don Stewart, CEO, PlantForm


Predictions are difficult, so my response is more focused on what I would suggest and what I hope for. In the case of biosimilar development, we may see more consideration of commercialization issues included in overall planning even as far back as portfolio selection.  Processes and resulting action plans should be linked together and iterative from day one onwards. 

An example to illustrate would be therapeutic area strategy and commercialization infrastructure needs. Why first decide what you need after a product has been developed, submitted, approved, and nearing launch?  Why not view the whole as a portfolio – rather than simply make product-by-product decisions – and take commercialization tactics, required infrastructure, and resulting business cases into account when choosing products at the point of portfolio selection?  One must, of course, be mindful of over-planning and over-analysis, but ignoring these points altogether simply leads to very costly mistakes.    

Regarding market access and commercialization efforts, I think we will see more sophistication develop regarding understanding the underlying incentives of each of the key stakeholders and executing against those as opposed to using traditional Rx or traditional Gx strategies. Rx strategies are based on relationships, the strength of the existing portfolio of in-market products, the pipeline to come, and the bizarre idiosyncrasies of the U.S. health care system that allow for win-win-win-lose situations for branded pharmaceutical firms, GPOs, PBMs, onco clinics (where appropriate), and payors — with the true payors being the losers in all of this. Gx strategies are predominantly driven by price competitiveness and sustainability of supply.  Neither set of strategies is sufficient for biosimilars, and, in some cases, are even grossly misaligned with the processes and incentives in place. If we push Rx or Gx approaches alone, we are likely to continue to see very low adoption curves relative to the actual potential that exists for biosimilars and the expectations we all had of this industry overall.    

And finally, I hope we will see more proactive efforts to engage for change, removing or at least lessening many of the most significant barriers the industry is facing. In particular, a focus on solutions that do not require legislative action would be key. For example, actions to remove the perverse incentive for oncology clinics to continually prescribe the most expensive products with ever-increasing prices under buy-and-bill would help, such as moving from Part B to Part D.  Another option would be to set a single constant dispensing fee irrespective of the price of the product. Other improvements would include greater transparency of pricing and pricing trends of products to patients as well as greater transparency to patients as to what medications and at what prices are actually at their disposal.    

          —Edric Engert, managing director, Abraxeolus Consulting


2019 will be a year in which we hope to get a great deal of clarity about outstanding regulatory pathway issues.

In March 2019, the FDA will issue a draft guidance on manufacturing process changes as they relate to biosimilars. While these have not been discussed in detail, we hope that the guidance will specify that after a biosimilar is approved, post-approval manufacturing variations and ongoing control of process and medicines should be regulated as it would with any other FDA-approved biological drug.

In May 2019, the FDA has committed to release a revised draft or final guidance on interchangeability. It will be interesting to see whether there are any changes from the initial draft and, if so, how those changes will affect biosimilar development.

Also in May 2019, the FDA has committed to issue a revised draft guidance on statistical analytical similarity. The initial draft guidance was withdrawn, which leads us to suspect that there will be changes in the next draft.

On the horizon for 2019, it is anticipated that the FDA will provide guidance on the transitioning of biologics now regulated as 505b drugs to become 351k biologics. BPCIA has specified that this will occur in March 2020 and guidance is sorely needed.

We are hopeful that the FDA will issue clarification of issues raised by the public in the past year on topics such as the potential use of ex-U.S. comparator reference medicine or simplified labelling procedures to remove or re-introduce information in biosimilar labels, as required to address potential patent rights of the reference product for specific indications.

Finally, while we had thought that the issue of biologics naming was resolved, the FDA has yet to issue suffixes to biologics that are already approved, including the reference medicines to biosimilars that are already launched and are available in the U.S. Furthermore, based on safety report data to-date, the four-letter suffixes are simply not being used in the U.S. for pharmacovigilance, which raises questions about the value of the new biologics naming convention in the U.S.

          —Hillel Cohen, executive director, scientific affairs, Sandoz


As far as biosimilar development is concerned, the biosimilar market continues to expand with $19 billion of current biotech spending predicted to be exposed to biosimilar competition for the first time in 20181. With at least 240 biosimilars in development, further growth is forecast. The European Union continues to lead the way, with more than 700 million patient days of positive clinical experience to date. As competition between biosimilar developers accelerates, improvement in production efficiency will be an essential factor in this battle of biosimilars.

When it comes to market access, Celltrion Healthcare has witnessed barriers to entering and promoting biosimilars in the U.S. market. One of the biggest barriers is posed by originator companies using rebates to incentivize payers to continue with originator drugs. This inhibits market competition, and there has been a strong need to improve cost transparency to create price competition.

In addition to having a transparent pricing system, biosimilar manufacturers should be able to offer competitive contracting terms to payers. Biosimilar would need to enter the market with a steep enough price discount to persuade with a message that the cost savings will be significant.

Biosimilars offer incredible health and economic opportunities in the U.S., but unless substantial barriers are surmounted, these opportunities will not be fully realized. Even absent reference product manufacturers’ efforts to retain market share, significant challenges for biosimilars arise because all parties involved — patients,  physicians, payors, and biosimilar manufacturers — need to realize gains from these products for the status quo to change.

          —HoUng Kim, head of strategy and operations, Celltrion


The most reasonable approach is to look at trends this year in each of these fields and see what would be a desirable evolution.

How are markets going to evolve? This has to be the toughest question. In the EU, for the past benefits to be reproducible for future biosimilar portfolios, there are still important policy features to fine tune, particularly in purchasing and procurement policies, but also in ensuring benefit-sharing models are implemented with patient benefits in mind.

Regarding biosimilar development and regulatory policies, from an EU perspective, we expect that the open dialogue with the regulators will continue on the evolution of comparability clinical trials going forward and the possibility of considering tailored programs as scientifically appropriate. Obviously, this cannot be a regional discussion and international dialogue will be needed. Discussions will continue on the need for a global comparator product and a smarter way to handle bridging studies. These are all relevant scientific issues which are key in ensuring the uncompromised quality, safety, and efficacy of biosimilars while fostering efficient development programs.

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


What’s interesting is that many of these areas are interdependent and will continue to be in 2019. I believe we will see a framework for interchangeability continue to be established, and that will also encourage greater acceptance of interchangeability among providers.

It is very possible that 2019 will be the year in which Medicare policies, which currently do not favor biosimilars, begin to change. Those updates likely won’t occur until the end of the year, but they will be preceded by commercial and private payers adjusting their approach to be more supportive and inclusive of biosimilars. In fact, we’re already seeing market indicators that these changes are coming. For example, Vizient, one of the largest GPOs, recently applauded the FDA approval of biosimilar UDENYCA; this is a signal to the market that stakeholders are starting to change their behaviors and be bolder in their support for biosimilars, which – in turn – will influence others (e.g., private and public payers).

Health systems are also a key stakeholder that will play a larger role in encouraging biosimilar adoption in 2019. Health systems are eager to realize the benefits of biosimilars and should be a key channel consideration for manufacturers moving forward. Education to health systems, as well as other providers and stakeholders, will need to be the bedrock of any commercialization plan. In fact, communication to all stakeholders should start well before a product’s launch, helping to prime the market for greater familiarity and comfort by the time the drug is available.

Communication and stakeholder alignment will be one of the largest themes for the year, and the need for both will only increase as we collectively prepare for policies related to the CMS Competitive Acquisition Program (CAP) proposals to go into effect in 2020.

Ultimately, biosimilar adoption will continue to be a slow process, but we are encouraged by what we see in the marketplace and what we know lies ahead. 2019 will be a year in which more stakeholders are invested in driving the necessary attention to speed approvals, increase competition, and further benefit patients.

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


In 2019, I do not expect to see significant changes in biosimilar development. The FDA is expected to release their final guidance on interchangeability in the first half of 2019. That is not to say that there will not be changes to biosimilar development in the future as the field continues to evolve, and it is hoped that the requirements for clinical data may decrease. I would like to see the market access for biosimilars open in 2019 in the U.S., but significant changes to the U.S. healthcare system are required and this may be difficult to achieve in one year. We certainly appreciate the Administration’s goals to address drug pricing, but it needs to be done in a sustainable way.

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


Biosimilar Development: Following developments in the last 12 months, 2019 will see the industry placing greater emphasis on biosimilarity at the preclinical level, which in turn will build more focus on the detail in manufacturing and analytics. In other words, we will see companies increasing investment in state-of-the-art CMC development — in chemistry, manufacturing and control processes and technological developments.

Market Access: In Europe, the market for biosimilars is well established and thriving compared to the U.S. where biosimilar options considerably lag behind Europe. The market access mechanics in Europe are well established, so we would expect further fine-tuning here. In contrast, we expect that uncertainty will remain to a certain extent in the U.S. in terms of biosimilars and market access over the next 12 months. However, this will improve as patients and health systems demand broader access to safe and efficacious biological therapies mid-term.

Commercialization Efforts: These efforts will further increase, putting greater focus on the unique characteristics of each biosimilar. Specifically, educational efforts will become more important. The number one priority in any educational programs is to bring biosimilar science to the patients and the medical community in an efficient, understandable way. The analytical part and the need for tailored clinical trials will be emphasized in education about biosimilars.

Regulatory Policies: The general trend towards evidence-based approaches in medicines applies to biosimilars as well. In line with the biosimilarity concept, biosimilarity is first established analytically and then confirmed on the clinical level. Regulatory thinking regarding the need for clinical studies will thus further develop towards specific and tailored studies instead of large, costly, and insensitive studies. Hence, the relevance of large clinical trials in less sensitive settings will further decrease, whereas the relevance of analytical data will further increase.

            —Ruediger Jankowsky, managing director, Cinfa Biotech


1. IQVIA 2018 and Beyond: Outlook and Turning Points. Published March 2018. Available at