20th July 2018

The Promise of Biosimilars

What is the role of biosimilars in the biologics market? How do they effect patients, providers…etc?

The Promise of Biosimilars

What is the role of biosimilars in the biologics market? How do they effect patients, providers…etc? What is their impact on innovation?

As discussed in our previous postBiosimilars Approval: Opportunities and Challenges,” Biosimilars are drug products that are “highly similar” to an FDA-approved biological product.

As the contemporary cousin of the generic drug, biosimilars provide promise in lowering healthcare expenditures and promoting pharmaceutical innovation through competition. The growing role of biosimilars, along with biologics in general, will be indispensable to both patients and healthcare professionals globally, who will rely on the pharmaceutical industry to develop the sector further.

Using Biosimilars to Increase Access and Reduce Cost

The increased frequency of non-communicable diseases in the modern era has caused an increase in healthcare spending. Diabetes, cancers and inflammatory diseases are more prevalent than ever and their treatment with biologic drugs is becoming increasingly important1 . The growing presence of biologics in the healthcare field also comes with an increased economic burden on patients. Current estimates indicate that the average daily cost of a biologic in the U.S. is $45 per day, while the average cost of conventional chemical drugs is about $22 . Even with a possible decrease in price since these data were captured, the disparity between biologic and conventional drug products is more than distinguishable. Thankfully, biosimilars are beginning to impact this burden by becoming more prevalent in the US healthcare market and reducing costs produced by previously unaccompanied biologics.

The average generic drug takes about 2 years and anywhere from $1-2 million to introduce to the market. Biosimilars, however, require anywhere from 5 to 9 years and around $135 million to develop.3 Considering these numbers, patients will be required to take on a much heavier financial burden, compared to generic drugs, but how does this higher cost compare to those of novel biologics?

The first FDA approved biosimilar, ZARXIO® (Filgrastim-sndz), led to an estimated 44% increase in the number of patients who were able to gain access to treatment in the EU, as a direct result of the price reduction this biosimilar provided4 . The approval of Zarxio® in the U.S. has led to savings of an estimated $65 a day for patients (when compared to the cost of the original biologic)5 . Overall, biosimilars are projected to save up to $44 billion in healthcare costs for the EU by 2020 and that number is likely to grow based on the rate at which the field is expanding4

As of December 2017, the FDA reported 59 biosimilar product development programs underway7. The FDA also indicated that it had received predevelopment meeting requests from many companies involving 23 different reference products at that time. It is estimated that this growing sector will be able to provide 1.2 million patients with access to biologic products in the US by 2025, which will increase access to low-income patient populations6.

The cost reduction that biosimilars provide, only has value if the medication is as safe and efficacious as the original biologic, which has been the case thus far. No biosimilar approved in the EU since 2006 has been withdrawn or suspended due to questioned safety or efficacy1 . The same goes for the US, where the FDA has been more cautious about approving biosimilars. This has allowed healthcare providers and patients safe, effective, and cheaper alternatives to high-priced biologic drugs across multiple therapeutic areas.

Driving Innovation

With biologics increasingly becoming the best option for treating many serious ailments, the role of biosimilars is crucial in providing increased accessibility without compromising safety or effectiveness. In 2017 alone, the number of biosimilars approved by the FDA increased from 4 to 9, while 11 approved biosimilars are currently available 7 . These numbers show a favorable level of interest in biologics, and as a result a healthy presence of competition driving the innovation of these products, amongst pharmaceutical companies. This competition can provide an incentive to continue developing novel products, as multiple biosimilar alternatives become more readily available for currently available biologics.

Increasing Presence and Facilitating Growth

With the increasing number of biosimilars on the market, the exposure patients and providers have to biologics will also increase. This exposure should bring increased familiarity, facilitating comfort in both prescribing biologics and using them. With a greater presence and broader acceptance, pharmaceutical companies will have an increased role in producing more of their drugs and developing new ones as demand increases. As biosimilars and biologics become recognized as standard pharmaceutical products, a positive cycle of use and development will follow.


All things considered, this is an exciting time for patients, healthcare providers and the pharmaceutical industry alike. As a continuous stream of revolutionary biologic treatments are being developed, as well as subsequent biosimilars, the ease of access to these products is increasing for both healthcare providers and patients, which has a direct impact on lessening the costs absorbed by hospitals, insurances, and patients. In parallel, biosimilars help drive innovation through competition amongst major pharmaceutical companies, which is required to meet the demand for safer and more effective biologic treatments. With their high similarity to biologics at a fraction of the cost, biosimilars should soon become as well known and appreciated for their impact as generic drugs are today.

Innovative Science Solutions (ISS) was intricately involved in developing the regulatory strategy for Zarxio®’s approval at the Oncologic Drugs Advisory Committee (ODAC) meeting back in 2015. ISS has almost two decades of experience in developing regulatory strategies, including support for FDA Advisory Committee meetings and has been involved in several biosimilar programs including the first ever biosimilar FDA approval. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

This post was authored by Sami Mourad and Kyle Powell. Sami is a summer intern at Innovative Science Solutions and a 3rd year pharmacy student at the Rutgers University Ernest Mario School of Pharmacy


1. The Economics of Biosimilars; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4031732/
2. Europe Demonstrates Benefits of a Strong Biosimilars Market;  http://www.insidesources.com/europe-demonstrates-benefits-strong-biosimilars-marketplace/
3. Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia; https://www.tandfonline.com/doi/abs/10.1080/13696998.2017.1358173?journalCode=ijme20
4. US Biosimilar Approvals Soar in 2017;  https://www.biologicsblog.com/us-biosimilar-approvals-soar-in-2017
5.  Cumulative number of biosimilar development programs in the BPD Program in the month; www.accessdata.fda.gov/scripts/fdatrack/view/track.cfm?program=cder&status=public&id=CDER-RRDS-Number-of-biosimilar-dev-programs-in-BPD-Program&fy=All
6. Let’s See How Biosimilars are Developed; www.pfizerbiosimilars.com/biosimilars-development
7. Biologics and biosimilars: what, why and how? ; ://esmoopen.bmj.com/content/2/1/e000180?utm_source=TrendMD&utm_medium=cpc&utm_campaign=ESMO_open._TrendMD-0


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