Next-Gen Generics: Complex Drug Formulations
Traditionally, generics have been straightforward, cost-effective alternatives to brand-name drugs. However, complex generics—medications with intricate formulations or delivery mechanisms—are reshaping the industry. These advanced formulations, such as extended-release tablets, transdermal patches, inhalers, and drug-device combinations, present unique challenges and opportunities for manufacturers.
Complex products represent nearly a third of branded drug products currently used, yet they face significantly less generic competition because they are harder to replicate and genericize. Complex generics are also more likely to face shortages due to demand, supply, and regulatory issues.
The generic pharmaceutical industry must continue to expand access to complex generics to make them readily available to patients who need them.
Advancements in Formulation Technologies
Complex generic medications have complex formulations, active ingredients, dosage forms, or administration routes. Tech advancements have improved the efficacy, bioavailability, and patient adherence of complex drugs while maintaining affordability.
Nanotechnology: By manipulating drugs at the nanoscale, nanotechnology enhances bioavailability and enables targeted delivery, ensuring that medications are more effective with potentially fewer side effects. Nanoparticles can improve the solubility of poorly water-soluble drugs, a common challenge in pharmaceutical development. A 2023 study highlights how nanotechnology-based drug delivery systems are revolutionizing treatments for chronic diseases, leading to better patient outcomes.
Lipid-Based Formulations: Lipid-based nanoparticle (LNP) drug delivery systems, such as liposomes and solid lipid nanoparticles, improve the solubility and absorption of hydrophobic drugs. These formulations also prevent degradation, help ensure consistent drug release, and reduce fluctuations in blood concentration levels.
3D Printing: This cutting-edge approach allows for customizing drug dosages and release profiles, tailoring treatments to individual patient needs. The FDA has approved the first 3D-printed pharmaceutical, but we’ve yet to see its widespread adoption in generic drug manufacturing. There is potential for 3D printing to streamline the production of personalized medicines, but we’ll likely need new progress in AI, buy-in from key stakeholders, and new regulatory standards before the technology can be widely used.
Microsphere and Liposome Technologies: Utilizing these carriers enables controlled and sustained drug release, maintaining optimal therapeutic levels over extended periods. Microspheres, composed of biodegradable polymers, gradually degrade to release the drug, reducing dosing frequency and improving patient compliance. Liposomes, which encapsulate drugs in lipid bilayers to form vesicles, protect sensitive active ingredients and enhance targeted delivery for gene therapy, cancer therapy, or injectable drug delivery.
Bioequivalence Innovations: Generics manufacturers must demonstrate bioequivalence (BE) to the reference drug, which can be challenging for nontraditional formulations. Advances in in-vitro testing and physiologically based pharmacokinetic (PBPK) modeling help predict drug behavior in the human body, proving BE and expediting FDA approval.
Impact on the Industry and Patient Care
Complex generics are more challenging to replicate and get approved, but competition is necessary to manage branded product pricing and ensure access to those who need it. One of the three key areas of the FDA’s Drug Competition Action Plan (DCAP) aims to streamline the regulatory requirements for complex generic drugs to reduce the “time, uncertainty, and cost of drug development.”
The complexity of these products naturally leads to higher development costs and longer approval timelines, but innovative formulation technologies provide a competitive edge. Manufacturers must balance innovation and expenses to increase market share and profitability.
That space of balance is critical to ensure manufacturers can survive and even thrive in the complex generic pharmaceutical space because increased industry participation is the only way patients can benefit from expanded access. These advanced formulations improve drug efficacy and patient adherence, and, for many medications, they are the only reliable option. Take asthma, for example. Inhalers are critical for the 262 million people worldwide affected by this condition, yet this common drug delivery method is considered complex. There is an urgent need to treat conditions like asthma, schizophrenia, and osteoporosis—and complex generics play a key role in their management.
Because they are harder to develop, fewer exist, creating less market competition for these products and resulting in higher prices or limited patient access. The more complex generics we can add to the list of FDA-approved medications, the more we can support the complex needs of patients everywhere.
Future Outlook
The future of complex generics is promising. As AI and machine learning are integrated into formulation development, we expect accelerated innovation and streamlined manufacturing processes to manage development costs and expedite approvals. Collaborations between pharmaceutical companies, regulatory agencies, and research institutions will advance complex generic drug development, enhance patient care, and address unmet medical needs. Westminster Pharmaceuticals is committed to collaborating with industry stakeholders to bring next-generation generics to market. By embracing these advancements, we aim to provide safe, effective, and affordable treatment options.
