Transforming Therapeutic Biologics: Finding New Administration Methods for Treatment
Prior to the advent of therapeutic biologics, patients who suffered from certain conditions such as metabolic disorders and autoimmune diseases had few options for treatment. For example, people with the inability to digest a certain amino acid would have to resign themselves to following a strict, lifelong dietary regimen instead. But with the use of these innovative drugs, their quality of life can be improved. Those very same people might now be able to eat certain foods without devastating consequences.
The good news comes with some complications, though. The most common mode of administering therapeutic biologics is through intravenous formulation. Most of the reasons for this revolve around the stability of the proteins that serve as the basis for these drugs. Compared to their small-molecule counterparts, biotherapeutics are notoriously fragile, which makes them difficult to store in the long-term. Additionally, high-concentration biologic solutions tend to affect efficacy due to protein aggregation. So despite the wide array of biologics available on the market or under development, delivery methods of these therapeutics have not quite kept pace.
Unfortunately, the reliance on intravenous administration may have to change. Rising costs of healthcare have put pressure on biologics companies to find other ways to deliver treatment. Is there any way to move biologics administration out of the hospital setting and into the patient home? Such a transition would lower healthcare costs while increasing convenience.
Alternate Administration Methods for Therapeutic Biologics
Some companies have already begun exploring other options. London-based Intertek is currently researching how to reformulate therapeutic biologics so that they can be administered via inhalation.1 When compared to the repeated injections typically required by intravenous formulations, nasal delivery offers convenience and causes less discomfort for the patient. It’s a non-invasive, needle-free alternative that still serves as a direct delivery vehicle via the respiratory system. It also doesn’t require the same amount of time to administer as an IV formulation, which can take several hours.
Other firms are focusing their efforts on oral administration, which remains the Holy Grail of drug delivery—especially in the case of treating chronic conditions. The main difficulty in administering biologics through a pill rests with our gastrointestinal system—or more precisely, the environment present in our GI tract. Biologic therapeutics are vulnerable to its acidity and native enzymes, so any carrier system would need to provide effective protection.2 At the same time, the carrier system could potentially exploit the conditions in the GI tract, as is the case with Rani Therapeutic’s so-called “robotic pill.” Intestinal acid is actually required to activate the pill’s function.3 It’s a creative solution to a known problem, and no doubt other companies will adopt similar out-of-the-box thinking in the pursuit of new formulations.
The Advantages of Developing Alternate Delivery Methods for Therapeutic Biologics
Companies don’t have to limit themselves to inhalation and oral delivery as alternative administration methods either. Pre-filled syringes, manual injector pens, and needle-free devices are other options as well. As long as it moves away from the classic delivery method of intravenous solutions toward formulations that are more convenient and comfortable for the patient, then it is a shift in the right direction.
Beyond prioritizing patient convenience, there are other reasons for companies to develop alternate methods. The Trans-Pacific Partnership has negotiated terms that affect the exclusivity period for biologics. By developing new administration methods for existing biologics, firms can extend data exclusivity, which would protect their intellectual property for a longer period of time and allow them to retain their market advantage. Formulating new administration methods would also give them a way to fend off the encroachment of competing biosimilars. After all, a non-invasive, convenient biotherapeutic formulation will be more attractive than a more expensive version with a difficult dosage schedule.
In fact, difficult dosing schedules are the number one reason for patient noncompliance. The discomfort associated with repeated injections and hours-long administration appointments often results in patients deviating from treatment schedules, which leads to poor efficacy. By transitioning away from invasive procedures like IV administration, patients are more likely to adhere to their dosage schedules. Better compliance leads to better treatment, which in turn improves the patient’s health. As a result, perception of the drug’s efficacy improves, thus boosting the company’s reputation.
Developing new administration methods may require additional investment on the part of life sciences organizations, but pursuing new formulations offers many benefits to counter the currently changing landscape of the therapeutic biologics market. Shifting regulatory guidelines and increasing competition from “generic” versions will only place more pressure on the sector, so firms will need to exercise every option to remain successful. The BIOVIA Biologics Solution is an innovative suite that supports all areas of therapeutic biologics creation—including development. While companies may not be starting from scratch when it comes to reformulations, they still need to determine the safety and efficacy of the new methods. Does the biotherapeutic reach and bind the target in an appropriate concentration and cause the appropriate effect without an adverse reaction? Firms must confirm that this is the case. With its ability to manage large amounts of complex testing data and provide better insights into resulting processes, the BIOVIA Biologics solution gives organizations the tools to create better products that will thrive in a competitive market. Please contact us today to learn more.
- “Intertek Researches Formulation Strategies to Repurpose Biologic Drugs,” December 1, 2015, http://www.businesswire.com/news/home/20151201005073/en/Intertek-Researches-Formulation-Strategies-Repurpose-Biologic-Drugs ↩
- “Biologics: the role of delivery systems in improved delivery,” March 19, 2014, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3964020/ ↩
- “Robotic Pills Could Simplify Administration of Biologic Drugs,” July 21, 2015, http://www.pharmacytimes.com/publications/issue/2015/july2015/robotic-pills-could-simplify-administration-of-biologic-drugs ↩