Pen-ding progress: Biosimilars aid to diabetes
Imagine yourself in a COVID-free world. No masks, no face shields, no distance. What would you first do? Go to the movies? Travel abroad? Party with friends? For me, the answer is none of the above. If there’s one thing I miss the most other than people, it would be spending special occasions at buffets — diverse cuisines, delicious food, and good company all in one place. Unfortunately, not everyone has the luxury of enjoying this cheat-day pleasure. More so, for people suffering from diabetes, such events can damage their body or even worse, lead to their death.
The Silent Killer
Nineteen thousand eighty pesos. That is the cost of maintenance medications for an individual suffering from diabetes excluding the cost of regular checkups, hospital stays, transportation and the like, every year. While there are various treatment therapies available, a good number of diabetic patients rely on insulin intake to survive. Due to the different enzymes in the stomach, insulin cannot be orally taken. Instead, it is commonly injected directly into the body through syringes or pens, one of which is a biological product brand-labeled drug called Lantus® [1]. Based on the prices of a local drug store, one pen with around twenty doses typically costs Php 1,060. These insulin injections must be taken daily to avoid complications. While there are cheaper options priced at Php 500 per dose, these commonly require two doses amounting to a much higher cost. While these numbers don’t seem intimidating for some, this is already equivalent to a child’s annual tuition fee for a typical Filipino working class family. For minimum wage earners tightening their belts to fit Php 500 a day for their household, this yearly spending means several months of unpaid electricity bills or even hundreds of missed meals [3]. For some Filipinos, getting diabetes is as good as a slow painful death for both the patient and its family’s pockets. But what is diabetes really?
Diabetic patients lack a hormone called insulin that enables the body to absorb and take in glucose or sugar from the blood. Once food is ingested, it is broken down into sugar, which is absorbed by our body to perform different functions. Due to the lack of insulin in patients with diabetes, glucose builds up in the bloodstream, causing complications to occur when left unmanaged. In the Philippines, diabetes ranks as the fourth deadliest disease in the country, with over 4,000,000 adult Filipinos diagnosed with it last 2020. While the three diseases ahead of it (heart diseases, cancer, and cerebrovascular diseases) recorded slight changes in the number of death-related cases compared to the previous year (2019), diabetes mellitus recorded a 7.8% increase in the number of deaths from the 2019 tally [2]. The continuous prevalence of diabetes caused it to be termed as the “silent killer” of our health society today.
The Promise of Biosimilars
Lantus or insulin glargine, is one of the many biological products in the market that is used to treat chronic health illnesses. These biological products, also referred to as biologics, are large molecules that are produced by or through living organisms. Due to the complexity of these products and the small yields, characterizing and producing them is far more difficult than creating the usual drugs, justifying their high market price [8]. However, with the advancements of technology and molecular information available today, alternatives to these products are starting to be developed: biosimilars. According to the Food and Drug Administration of the United States (FDA), a biosimilar is a “biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.” Biosimilars thus offer almost the same safety, purity, and efficacy as those of branded biologics such as Lantus.
Prior to its approval and distribution, a biosimilar has to be well-characterized, especially its mechanism of action [3]. The biological activity, purity, and immunological and physicochemical properties of a proposed biosimilar are compared to an already authorized biological product (i.e., reference product) [3]. Reference products and the proposed biosimilar should have little to no meaningful differences for the proposed product to be considered a biosimilar.
Manufacturing these products is a whole other complicated process. Contrary to generic drugs, biosimilars are manufactured from living cells; this makes the manufacturing conditions difficult to duplicate and manage [4]. From small-scale to mass production, the production of biosimilars must follow a strict protocol as even the subtlest changes in conditions may alter the drugs’ potency and calculated dosage. Last July 28, 2021, Semglee®, also called insulin glargine-yfgn, was approved by the FDA as the first interchangeable biosimilar product for the insulin therapy treatment product Lantus [5]. This too comes in the form of an injector pen, offering diabetics another choice at a lower price.
With the entry of biosimilars to the market, consumers now have a wider variety of options to choose from; options that are just as effective but not as painful for the pocket. Although intensive research must still be done, with the help of a reference product like Lantus, biosimilars are formulated over a relatively shorter period of time with less human and material resources exhausted. Biosimilar drugs are also relatively smaller and less complex molecules compared to biologics, making them easier to manufacture and decreasing the long-term costs [4].
Our Pen-ding Situation
In a previous study from 2018, it was said that despite the approval of interchangeable biosimilar products, its commercialization remains a struggle due to the barrier reference product companies put up [6]. While this is another problem in itself, it takes more than science alone to be given a chance at ever reaching mass production of biosimilars. As for the Philippines, following a 2011 planning conference, only four biosimilars have been approved by the Philippine FDA, two of which are antidiabetic products [7]. In spite of this, the availability and price-competitiveness of these products in the market still remain different from its intended purpose: the creation of more accessible biological products. The lack of awareness among physicians that prescribe these drug therapies also contributes to this issue, but it is the evident lack of scientific industries in the Philippines that serves as the biggest hurdle in the utilization of these cost effective measures that have the potential to save thousands of Filipinos’ lives.
Will that day ever come? Will science ever be acknowledged in the Philippines? Sometimes, I wonder about these things too; but after this pandemic and the gradual recognition of science and research, I want to believe that there is hope for science in this country too. In a world where money is as important as it is significant, biosimilars offer an opportunity for everyone to have a chance at life. While the ideal effects in the Philippines are still far from sight, with the inevitable advancements in science and technology, the future of biosimilars is indeed bright.
References
[1] Mayo Clinic (2020, October 30). Diabetes. Retrieved from https://www.mayoclinic.org/diseases-conditions/diabetes/symptoms-causes/syc-20371444
[2] Cudis, C. (2021, May 7). Diabetes among top killer diseases in PH. Philippine News Agency. Retrieved from https://www.pna.gov.ph/articles/1139440
[3] US Food and Drug Administration (2017, October 23). Biosimilar and Interchangeable Products. Retrieved from https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products
[4] Samsung Bioepis (2019). Science & Technology: About Biosimilars. Retrieved from https://www.samsungbioepis.com/en/science/science01.do
[5] US Food and Drug Administration (2021, July 28). FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes. FDA News. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes
[6] Chen, B. K., Yang, Y. T., & Bennett, C. L. (2018). Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court’s Recent Rulings do not Solve Fundamental Barriers to Competition. Drugs, 78(17), 1777–1781. https://doi.org/10.1007/s40265-018-1009-0
[7] Food and Drug Administration (2019, January 1). List of Approved Biosimilars. Retrieved from https://www.fda.gov.ph/list-of-authorized-biosimilars-as-of-1-january-2019/
[8] Morrow, T., & Felcone, L. H. (2004). Defining the difference: What Makes Biologics Unique. Biotechnology healthcare, 1(4), 24–29.
Written by Kristina Dela Cruz
Proofread by Sophia Abulencia, Megan Gozum, Gabbie Lagdameo, Via Ogasawara, and Rhaena Pablo
Art by Kristina Dela Cruz
