Pharmacists' Role in the Emerging Biosimilar Market

Biosimilars have become increasingly popular in the last few years. They’re currently used to treat a variety of diseases like cancer, rheumatoid arthritis, and diabetes.

In 2014, 10 of the top 25 best-selling drugs in the United States were biologics and biosimilars.² This year alone, 3 biosimilars were approved: Pfizer’s Inflectra biosimilar to Remicade, Sandoz’s Erelzi biosimilar to Enbrel, and Amgen’s Amjevita biosimilar to Humira.

By 2020, biosimilars are estimated to reach a market value of $11 billion.³ The market for biosimilars will grow and flourish for years to come and continue to change the pharmacy field.

Biosimilars are highly similar to biologics, but not the same drug. With many biologics nearing patent expiration, more biosimilars will surely reach the US market. It’s estimated $54 billion worth of patents will expire before 2020.⁴ However, pharmacists must address several key issues before biosimilars are fully implemented in clinical practice, including interchangeability, pharmacovigilance, economic considerations, and reliability of supply.

The approval process for biosimilars is slightly different from generics since they may not include interchangeability. Oftentimes, additional data is needed to support interchangeability between the biosimilar and reference drug. This is an area of opportunity for pharmacists to use their clinical knowledge to support or deny the use of biosimilars in unapproved disease states.

Pharmacists may be involved in creating clinical trials to demonstrate that biosimilars have the same mechanism of action, target-binding characteristics, and pharmacokinetics in the clinically tested and the extrapolated indications, as well as addressing any expected differences in toxicity or effectiveness.¹ Pharmacists can also participate in pharmacy and therapeutic committees to determine whether biosimilars belong on the formularies of hospitals, managed care organizations (MCOs), or pharmacy benefit managers (PBMs).

Pharmacovigilance is another area where pharmacists can play an important role because biosimilars are very complex and new, so there’s a lack of long-term safety and efficacy data. There needs to be robust safety monitoring after biosimilars’ approval to accurately track and record adverse events.

This is a booming area as more pharmaceutical companies and academia offer fellowships to pharmacists designed to gather data on outcomes and postmarketing surveillance. These duties are similar to the normal duties pharmacists encounter every day, including adverse event reporting and REMS procedures. Although they may be time-consuming and tedious, the patient’s health and safety must be our greatest priority.

Biosimilars offer a potential opportunity to increase patient access to biologics by stimulating price competition and lowering health care costs.¹ A 2014 analysis estimated biosimilars could save the US health system $13 billion to $66 billion.⁴

Pharmacists working in MCOs and PBMs can be the key driver to reduce out-of-pocket costs and increase reimbursements while increasing biosimilar use. They have the capability to evaluate all economic factors, including cost effectiveness and outcomes data, before making the decision to approve the inclusion of biosimilars in their formulary.

Lastly, the robustness of the manufacturer’s supply chain is important to consider when evaluating biosimilars.¹ Because of the complexity of biologics, biosimilars are more difficult to duplicate, which could pose a challenge. This is extremely important in the oncology field because if the biosimilars supply were unreliable, patients wouldn’t receive scheduled chemotherapeutic doses, putting their lives in jeopardy. Pharmacists can play a huge role in developing robust protocols to ensure better reproducibility.

Overall, pharmacists can play a large role in the upcoming rise of biosimilars by tackling issues like interchangeability, pharmacovigilance, economic considerations, and the reliability of supply to ensure biosimilars’ safety and efficacy.

References

• Camacho LH, et al. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014;3(4):889-899.
• Philippidis A. The top 25 best-selling drugs of 2014. Genetic Engineering & Biotechnology News. genengnews.com/keywordsandtools/print/3/37387. Published February 23, 2015.
• U.S. biosimilars market worth $11bn by 2020 - 22% CAGR forecast for global biosimilar industry in new research reports. PR Newswire. prnewswire.com/news-releases/us-biosimilars-market-worth-11bn-by-2020---22-cagr-forecast-for-global-biosimilar-industry-in-new-research-reports-521792001.html. Published August 13, 2015.
• AMCP Partnership Forum: Biosimilars—Ready, Set, Launch. J Manag Care Spec Pharm. 2016;22(4):434-440.