By Pepa Barragan, Toni Nikolova & Kurt Brorson, Parexel Regulatory Consulting Services
The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients suffering from this disease which seems to hit us with fierce new complications every week. Remdesivir, a broad spectrum antiviral medication, has been authorized for emergency use in COVID-19 patients while its safety and effectiveness for the treatment of this disease are still under investigation. While Governments can build stockpiles of drugs to treat emerging pathogens, the various drug makers licensed to commercialize these drugs struggle to meet unpredictable and unprecedented demand, with several drug shortages already announced by the FDA1.
In addition, several clinical studies are bringing more attention towards drugs capable to specifically modulate the strong immune cascade that some patients undergo in response to SARS-CoV-2 infection. Some of these drugs are already included in the standard of care to treat severe cases of COVID-19 including interleukin 1 and 6 (IL-1 and IL-6) inhibitors (generically referred to as “immunomodulators”) 3. These inhibitors, currently under investigation as potential COVID-19 treatment, are only available as branded versions on the market (no biosimilars, biologic medical products highly similar to another already approved biological medicine, have been developed for any of these drugs). Hence, given the absence of additional manufacturers licensed to manufacture biosimilar versions of these drugs, the responsibility or producing enough to meet market demand relies on a single drug maker.
In this blog, we discuss how rapid development of biosimilars is another avenue to assure a consistent and affordable supply for patients in times of unprecedented increasing demand.
One potential mitigation
Immediate response to COVID-19
The use of IL-1/6 and IL-1/6 receptor blocking antibodies, commercialized for other indications, e.g., autoimmune disorders such as rheumatoid arthritis (RA), an alternative to treat severe COVID-19 cases while clinical trials in this new patient population are still ongoing. Of the few IL-6 targeted drugs approved in the US, tocilizumab is the earliest in the COVID-19 treatment race, having received the FDA approval to progress to Phase III clinical trials on March 26, 2020. The fast-increasing demand for tocilizumab, is further underlined by a recent statement from Roche, its only license holder: “is working urgently to accelerate manufacturing capacity to maximize its production, wherever possible, with the goal of increasing available supply globally.”
With respect to IL-1 inhibitors, three biological drugs are currently commercialized in the US: the IL-1 receptor antagonist anakinra, the soluble decoy receptor rilonacept and the neutralizing monoclonal anti-IL-1β antibody canakinumab with anakinra being currently under investigation as a potential COVID-19 treatment.
The fast-growing demand for these drugs due to not only the multiple ongoing clinical trials but the emergency use worldwide to treat severely ill COVID-19 patients, raises concerns of potential drug shortages that can happen if a newly identified anti-COVID-19 becomes authorized under EUA (Emergency Use Authorization) when the manufacturing firm is still scaling up production.
A solution for this dire situation could be fast approval of biosimilars for the aforementioned drugs, roughly equivalent to generic versions of biologics. The main benefit of using biosimilars in this context is increasing the probability of being able to meet a rapidly expanding demand with a more robust market supply from more than one source.
Benefits from the Approval of Biosimilars
In order to facilitate the approval of biosimilar drugs, the US Congress enacted in 2009 the Biologics Price Competition and Innovation (BPCI) Act4 as an amendment to the Public Health Service (PHS) Act, creating a legal frame to allow an abbreviated approval pathway to offer the public with greater access to safe and effective biological products.
For patients, the approval of biosimilars may represent the only alternative of treatment due to the extremely high cost of many original biologics. It is expected that by 2023 biosimilar competition in the biologics market will be nearly three-times larger than it was in 2018, resulting in approximately $160 billion reduction in medical expenses over the next five years5. Thus, the development of biosimilar products, treating multiple types of cancer, autoimmune diseases among others, represents an appealing business opportunity for the pharmaceutical sector and an increasing public health need, given the growing demand for biotechnology drugs.
CONCLUSION AND WHY PAREXEL
In comparison to small molecule drugs, biological drugs have a more complex and lengthy manufacturing process. In addition, the development of biosimilars requires extensive characterization in order to demonstrate high similarity to the original molecule, which is a current regulatory requirement. Yet, the production of biosimilar drugs remains at a fast-increasing demand and represents not only an advantage for patients but a remarkable profitable opportunity for drug makers.
Parexel consulting group counts on a team of international regulatory experts able to provide valuable advice to support the approval of biosimilar products around the globe. Our group of experts include 1,000 consultants and over 80 former regulators and policy makers with direct experience in the most influential pharmaceutical Regulatory Agencies in the world, familiar with the applicable regulations, guidelines and recommended practices that will facilitate the approval of the new biosimilar products.
- COVID-19: consider cytokine storm syndromes and immunosuppression. The Lancet (vol. 395, Issue 10229, p1033-1034, March 28, 2020)
- Section 351(k)(2)(A)(i)(I)(aa) of the Public Health Service (PHS) Act
- The Global Use of Medicine in 2019 and Outlook to 2023. Forecasts and Areas to Watch Institute Report (January 29, 2019)