By: Michael Lim, PharmD Candidate c/o 2020
In an era of widespread pharmaceutical innovation, the rise of biological products is no surprise. Biosimilars – biological products that are highly similar to and have no clinically meaningful differences compared to reference products that are approved by the Food and Drug Administration (FDA) – have taken an increasing role in the treatment of a variety of disease states over the last few years.1 From cancer to genetic disorders, biosimilars offer a lower-cost alternative and are de facto copies of billion-dollar biotech drugs. Biosimilars are also intended to decrease drug prices through promoting competition in the pharmaceutical market.2 However, entry of biosimilars to the market is often blocked by court actions.3 Of the eleven biosimilar drugs that are currently FDA-approved, eight have been kept off the US market via litigation and other strategies employed by big brand-name drug companies such as Amgen or AbbVie.3 Consequently, despite their cost lowering intentions, prices remain steep with biologics representing almost forty percent of all prescription drug spending and accounting for a seventy percent growth in drug spending from 2010 to 2015.2,4 The FDA, refusing, “to play regulatory Whac-A-Mole with companies trying to unfairly delay or derail the entry of biosimilar competitors,” revealed its Biosimilars Action Plan (BAP) in July 2018.3
The BAP emphasizes four main strategies supported by a plethora of key actions. These strategies include improving the efficiency of the biosimilar development and approval process, clarifying regulatory information, improving communication and understanding of biosimilars, and fostering competition.5 Building on the 2010 Biologics Price Competition and Innovation Act, the plan includes key actions to facilitate the approval and entry of biosimilars to the market. For example, to accelerate the biosimilar approval process, the plan revealed a goal of creating biosimilar-review templates.3 These standardized review templates aim to improve the efficiency of FDA review and increase public information about the FDA’s product evaluation.2 In addition, the plan mentions the creation of development tools to assist biosimilar drug development.2 These tools include silico models and simulations to help correlate pharmacokinetic and pharmacodynamic responses of drugs with their actual clinical performance.2 The BAP also calls for the development of an index of critical quality attributes which would be used to compare potential biosimilars to reference products.2
To improve coordination with regard to development and approval activities, the FDA plans to transition its current biological product management staff to establish an Office of Therapeutic Biologics and Biosimilars (OTBB).2 With this new central hub, the FDA expects to accelerate response time to stakeholders, provide advice to developers, review application materials, and create guidance documents to support policy development and supply regulatory clarification of the biosimilar approval process.2 While these actions enhance coordination at the national level, the BAP also outlines outreach beyond the United States. By strengthening partnerships with regulatory authorities in Europe, Japan, and Canada, the FDA anticipates even greater coordination and efficiency in developing biosimilars.2
In hope of being able to furnish easy and applicable information about biological products, enhancements to the Purple Book, which lists all FDA-approved biologic and biosimilar products, are scheduled.2 Additionally, advanced efforts are planned for data collection and spreading education on the topic of biosimilars.2 Some methods to be utilized in the future include educational videos that explain key concepts about biosimilars and webinars that emphasize the rigor of the development and approval process.2 Through these lessons, the BAP forecasts improved understanding among patients, clinicians, and payers.2
To promote competition, the action plan calls for the evaluation of firms that may be manipulating regulatory requirements to unfairly delay the introduction of new biosimilars to the market.2 For instance, some drug makers will refuse to sell drug samples that are necessary for developing the generic or biosimilar product.2 As a result, entry of these potential biosimilars to the market is prevented. Coordinating with both the Federal Trade Commission and legislators, the FDA will combat such anticompetitive behavior and seal any regulatory loopholes that are being exploited to create delays.2
The FDA serves an important role in balancing innovation with competition. While incentives such as exclusivity periods entice developers to pioneer new biological products, competition which lowers prices must also become available when such periods have lapsed. In fact, an analysis has shown that if Americans had the opportunity to purchase more successfully marketed biosimilars, they would have collectively saved more than $4.5 billion in 2017.5 With the FDA’s Biosimilar Action Plan, a fairer and more streamlined approach to introducing new biosimilars to the market may be on the horizon.
- Center for Drug Evaluation and Research. Biosimilars – Biosimilar and Interchangeable Products. U S Food and Drug Administration Home Page. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm. Published 10/23/2017. Accessed 7/31/2018
- U.S. Food and Drug Administration. Biosimilars Action Plan: Balancing Innovation and Competition. https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm613761.pdf. Published 7/2018. Accessed 7/31/2018.
- Burton TM. FDA unveils effort to get ‘biosimilar’ drugs on the market faster; cheaper copies of complex biotech drugs face regulatory, legal hurdles. Wall Street Journal (Online). Jul 18 2018. Available from: http://jerome.stjohns.edu:81/login?url=https://search-proquest-com.jerome.stjohns.edu/docview/2071280312?accountid=14068.
- Mulcahy AW, Hlavka JP, Case SR. Biosimilar Drugs May Reduce U.S. Health Spending by $54 Billion. RAND Corporation. https://www.rand.org/pubs/perspectives/PE264.html. Published 10/23/2017. Accessed 7/31/2018.
- Food and Drug Administration. Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm613881.htm Published 7/18/2018 Accessed 7/31/2018.