In 1984, the United States approved the Hatch Waxman Act to boost competition among generic medicinal products. These now comprise 90% of prescriptions across the country, generating savings for the healthcare system of 1 trillion dollars. In 2017 alone, the savings amounted to 265 billion dollars1.
Biological medicinal products represent almost 40% of total spending on medicinal products in the United States, with 70% growth between 2010 and 20151. The FDA considers that, as with generic medicinal products, biosimilars may offer large savings to the healthcare system, especially when there are two or more biosimilars from the same biological reference medicinal product.
However, while the development costs of a new generic medicinal product peak at around 10 million dollars, it is estimated that between 100 and 250 million is required to develop a biosimilar2.
Because of this, the FDA believes that a more competitive biosimilar market would be advantageous, with incentives for companies to commit to the investment required for their development, which would bring many benefits to patients and to the healthcare system1.
To achieve this, the FDA has put a plan into effect which aims to stimulate innovation and competition between biological medicinal products and promote the development of the biosimilar market, making sure that this virtuous circle of innovation and competition mainly benefits patients1.
The plan focuses on four key areas1,3:
- Improving the efficiency of the biosimilar development and approval processes. For example, by creating an index of critical quality attributes for biosimilars, developing computer simulations to correlate their pharmacokinetic and pharmacodynamic responses with their clinical responses, or improving coordination between evaluating organisations to reduce biosimilar approval time.
- Make scientific and regulatory requirements for biosimilar approvalclearer. In this regard, efforts will be made to harmonise the international regulations governing biosimilars. The use of actual clinical experience of biological medicinal products to take decisions related to biosimilars will also be assessed.
- The development of educational initiatives to improve the understanding of biosimilars among patients, clinicians and payors. For example, by creating audience-appropriate, innovative educational videos and materials, as well as carrying out webinars and other online events and participating in social media and discussion forums.
- Supporting market competition by preventing attempts to delay the entry of new competition into the market. This involves working accordingly with legislators to close legal loopholes that allow anti-competitive practices, while also taking legal action when this conduct is recognised.
In Europe, the approval of over 40 biosimilars since 2006 demonstrates the credibility of their scientific foundation and the quality of the regulatory and decision-making processes4.
In the United States, the biggest healthcare market in the world5, while the FDA has approved 12 biosimilars, only 4 have entered the market. This delay has cost American patients 4.5 billion dollars2. The FDA’s new plan is an attempt to improve this situation, seeking a balance between the development of new biological medicinal products and a healthy, competitive biosimilars market1.
- Innovation B. BIOSIMILARS ACTION PLAN: Balancing Innovation FDA’s Biosimilar Action Plan (BAP) Introduction and Overview: Balancing Innovation and Competition. 2018; (July). Available at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580433.htm#action
- Wechsler J. FDA Struggles to Advance Biosimilars. http://www.pharmexec.com/fda-struggles-advance-biosimilars.
- FDA Announces Biosimilars Action Plan with Surprising Rhetoric – Lexology. https://www.lexology.com/library/detail.aspx?g=104e6121-34b0-4ab8-9c29-56100bcad9f5. Accessed 13 August 2018.
- Deloitte. 2018 Global health care outlook: The evolution of smart health care. 2018:1–31.