Biosimilar Uptake Implies Patient Access to Affordable Medication

The Center for Biosimilars (CB) interviewed Brian Lehman, MBA, MHA, RPh, manager of Pharmacy Benefits and Policy, Columbus, Ohio, and editorial board member of CB, to discuss challenges and opportunities in this rapidly developing field.

CB: What do you think is the best way to expand familiarity with biosimilars in the medical healthcare community?

Lehman: The medical healthcare community needs unbiased, comprehensive, up-to-date information on biosimilars. They need information to fill gaps in knowledge:

• Defining biologics, biosimilars and biosimilarity
• Understanding the approval process and the US Food and Drug Administration’s (FDA’s) use of totality of evidence to evaluate biosimilars
• Appreciation that the safety profile of a biosimilar is expected to be the same as that of the reference product
• Understanding how decisions are made by the FDA for extrapolation of indications
• Defining interchangeability and the related rules regarding pharmacy-level substitution¹

In order to expand familiarity with biosimilars, it will take multi-pronged communication strategies to be implemented by manufacturers. Biosimilar manufacturers, especially those who currently have biosimilar products in the market, have a large responsibility in expanding familiarity with biosimilars in general as well as for their specific product(s).

Other stakeholders are key to helping expand familiarity with biosimilars. The Academy of Managed Care Pharmacy's Biosimilar Resource Center offers educational resources and information on biosimilars to health care providers and other stakeholders. The Biosimilars Council provides resources and educational events. The FDA provides information on biosimilars.

CB: How can the oncology community in particular benefit from extended knowledge of biosimilars and, conversely, benefit the biosimilar industry?

Lehman: The more knowledge that the oncology community has on the safety and effectiveness of biosimilars as well as answers to gaps in knowledge, the more the community will have confidence and acceptance of biosimilars. This increased confidence and acceptance by providers and patients will then translate into manufacturers capturing higher sales and market share for their biosimilars.

The oncology community is currently impacted by one biosimilar Zarxio (filgrastim) that has been available on the market since September 2015. Zarxio, the biosimilar for Neupogen, is a granulocyte colony-stimulating factor that stimulates the growth of neutrophils that are important in the body’s fight against infection. Note that the FDA has currently approved only 5 biosimilars.

The oncology community will be impacted in the future with additional biosimilars for Neupogen, Neulasta and Procrit/Epogen. Additionally, the first biosimilar to Herceptin (used to treat certain HER-2 positive breast and gastric cancers) as well as the first biosimilar to Avastin (used for non-small cell lung cancer, renal cell cancer, metastatic colorectal cancer and other region-specific indications) are currently being reviewed by the FDA.

The biosimilar pipeline is robust; the FDA has 66 biosimilars programs enrolled for 20 different reference products

, said

(

John Jenkins, the director of the FDA’s Office of New Drugs,

in

October 2016

)

.²

CB: Do you believe that biosimilar treatment options will make treatment more affordable?

Lehman: Yes, biosimilar treatment options will make treatment more affordable for patients. Initially, we have seen that when only one biosimilar product is available on the market, it is priced 15% off the reference product list price (for example, Zarxio priced 15% off the list price of Neupogen).

Biosimilars will be at least 10% to 30% less than the reference product. The potential for cost savings will vary across biologic drug classes based upon factors such as sales, degree of competition and timing of biosimilar entry.

I believe in the future, when several competing biosimilars to the same reference product are available in the market, the discounts will likely exceed 30% less than the reference product. The even larger savings and affordability that providers and patients are looking for will come to fruition when multiple competing biosimilars are available in the US market.

Biosimilars will help reduce healthcare premiums as well as out-of-pocket costs (such as deductibles and copays) that are mostly being driven by biologic drugs. The biosimilars market is expected to create anywhere from $44 to $250

million

in health systems savings over 10 years (2014-2024) according to various estimates.^3,4

CB: What would be the best-case scenario for biosimilar incorporation into mainstream medicine from a healthcare policy/cost perspective?

Lehman: Ideally, healthcare policy will support a robust biosimilar marketplace which will ultimately lead to improved patient access to more affordable biologics. Manufacturers will continue to need a policy environment that will encourage them to develop biosimilars, such as removing the barrier of restricted access to some reference products that prevent manufacturers from developing competing biosimilars (this could be addressed through the FAST Generics Act or CREATES Act)⁵ and drug patent battles that delay biosimilars from entering the market even after FDA approval.^6,7

From a cost perspective, ideally biosimilars will provide significant savings relative to the cost of the reference product, in order to help improve patient access. But, there is a need to balance and monitor for the potential unintended consequence of discouraging some manufacturers from bringing more biosimilar competition to the US market.

CB: What, in your opinion, is the greatest benefit represented by biosimilar uptake?

Lehman: The greatest benefit would be increasing patient access to more affordable life-changing and even life-saving biologic drugs. Hopefully we will see this happen in the US as was seen in the UK in 2009, when within 3 years of the introduction of the biosimilar filgrastim, patient access to filgrastim nearly doubled.⁸

CB: Do you recognize the need for educating healthcare professionals and patients on biosimilars?

Lehman: Yes! Education on the safety and effectiveness of biosimilars is a key component to the success of the biosimilars market. This was one of the keys to increasing generic drug utilization post Hatch-Waxman Act and has contributed significantly to the 89% generic drug utilization in the US.⁹

Healthcare professionals need education in order to have a better understanding and knowledge of biosimilars, so that they feel comfortable about administering biosimilars to patients. Healthcare professionals need unbiased, comprehensive, up-to-date information on biosimilars.

Patients need education in order to feel confident that a biosimilar is just as safe and effective as the reference product. They need to know information such as the FDA has stringent product approval standards for biosimilars and that biosimilars have an established international track record. Europe has experienced over 400 million patient days of safe and effective treatment using biosimilars since the first biosimilar was approved and marketed in 2006.¹⁰

References

1. Cohen H, Beydoun D, Chien D, et al. Awareness, knowledge, and perceptions of biosimilars among specialty physicians. Adv Ther. 2017;33(12):2160-2172. doi: 10.1007/s12325-016-0431-5.

2. Welch AR. How to make the most of your FDA biosimilar meetings. Biosimilar Development website. https://www.biosimilardevelopment.com/doc/how-to-make-the-most-of-your-fda-biosimilar-meetings-0001. Published November 14, 2016. Accessed April 25, 2017.

3. Mulcahy AW, Predmore Z, Mattke S. The cost savings potential of biosimilar drugs in the US. RAND Corporation website. https://www.rand.org/content/dam/rand/pubs/perspectives/PE100/PE127/RAND_PE127.pdf. Published November 2014. Accessed April 25, 2017.

4. The $250 billion potential for biosimilars. Express Scripts website. http://lab.express-scripts.com/lab/insights/industry-updates/the-$250-billion-potential-of-biosimilars. Published April 23, 2013. Accessed April 25, 2017.

5. Brennan Z. ‘FAST’ Generics Act seeks to thwart abuse of FDA safety programs. Regulatory Affairs Professionals Society website. http://www.raps.org/Regulatory-Focus/News/2017/04/10/27309/‘FAST’-Generics-Act-Seeks-to-Thwart-Abuse-of-FDA-Safety-Programs/. Published April 10, 2017. Accessed April 25, 2017.

6. Brennan Z. US Supreme Court to consider biosimilar patent process next week. Regulatory Affairs Professionals Society website. http://www.raps.org/Regulatory-Focus/News/2017/04/20/27383/US-Supreme-Court-to-Consider-Biosimilar-Patent-Process-Next-Week/. Published April 20, 2017. Accessed April 25, 2017.

7. AbbVie v Amgen. Big Molecule Watch website. http://www.bigmoleculewatch.com/abbvie-v-amgen/. Published October 14, 2016. Accessed April 25, 2017.

8. Walsh K. Biosimilars’ utilization and the role payers do play in driving uptake in Europe: an industry perspective. Paper presented at: Biosimilar Medicines 11^th EGA International Symposium; April 25-26, 2013; London, UK. Accessed April 25, 2017.

9. Association for Affordable Medicines: 2016 annual report. AAM website. http://accessiblemeds.org/wp-content/uploads/2017/02/AAM-Annual-Report-2017.pdf. Published February 2017. Accessed April 25, 2017.

10. Did you know?: biosimilar medicines. Medicines for Europe website. http://www.medicinesforeurope.com/biosimilar-medicines/did-you-know/. Published March 2016. Accessed April 25, 2017.