Rising to the challenge of developing inhaled generic medicines
medicines helps provide affordable alternatives to branded products, ultimately
providing patients with lower cost access to expensive treatments. While
generic medicines account for roughly 80% of all prescriptions in the US,
inhaled generics represent less than 1% of this figure.
Vectura’s Senior Vice President for Generic Programmes, Martin Oliver, explains what is required to bring both an inhaled generic drug and the device needed to administer it to the US market, and why very few companies have the expertise to effectively do this.
As patient numbers grow and place a higher demand than ever on healthcare services globally, many payors see generic medicines as a key element of prescribing strategies, meaning greater access to essential medicines for patients and significant savings for healthcare systems.
Despite the size of the US generics market, and the prevalence of asthma and COPD, to date there have been no approvals of complex inhaled substitutable drug-device combinations.
Why? These are difficult-to-make products. While oral small molecule drugs and injectables are easy to imitate, replicating an inhaled therapy is more challenging because it involves successfully meeting the requirements to match the reference drug, formulation and the delivery device – both individually and when combined altogether.
Drug access is a matter of public health concern. We know that enabling more generic competition…helps reduce prices, enable more access, and improve public health.
- Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration, Oct 2017
Martin explains: “In the US, generics manufacturers need to demonstrate ‘substitutability’. This means a pharmacist can substitute products as they dispense them if the regulator, the Food and Drug Administration (FDA), has approved the products as equivalent pharmaceutically and therapeutically. The intent is to create competition and prevent drug costs escalating for patients and for payors.”
“This approach has been used successfully for many years with relatively simple dosage form designs, such as tablets. But with more complex inhaled products, both the device and the drug have to combine to deliver the same effect within the body. For a generic inhaler – either a Dry Powder Inhaler (DPI) or a Metered Dose Inhaler (pMDI) – to be approved by the FDA, a patient must be able to use the device without instructions in the same way as the reference product and the product must produce the same clinical effect.”
Devices and drugs are covered by different patents, so even the choice of when to begin these complicated R&D programmes is complex for generic pharmaceutical development companies.
“The equivalence of the device, dose and clinical effect are all taken in to account by the regulator, and combined to provide a ‘weight of evidence’,” explains Martin, “meaning a company needs knowledge in all these areas, as well as regulatory experience and the ability and knowhow to manufacture these complicated products.”
Vectura is one of the few companies with this proven device design and development, pharmaceutical development and clinical and regulatory capabilities. Although the barriers are high, the market opportunity is significant and Vectura is uniquely positioned to succeeding in this area.
“Development of inhaled generics requires specialised capabilities which are scarce in the industry but are core competencies of Vectura. We are at a very exciting stage, helping to provide valuable access to important medicines for patients.”
- James Ward-Lilley, CEO, Vectura
Vectura is the partner of choice for major pharmaceutical companies, such as Hikma and Sandoz, and together with these partners we strive to reliably supply affordable, high-quality generic medicines to meet today’s healthcare needs.
Inhaled drug formulation and device capability is at the heart of what we do and our confidence in this – along with the substantial market opportunity - is why this year we have increased investment to develop further high-potential generic medicines.
Our mission is to improve patients’ lives by providing high-quality, affordable alternatives to common inhalers, both now and in the future, alongside reducing costs to healthcare systems, and creating value for our shareholders.
A generic drug is a medication that has exactly the same active ingredient as the branded reference product and yields the same therapeutic effect. It has the same dose, safety, efficacy and quality.
A standard generic is a simple dosage form, such as a tablet or capsule, using standard manufacturing and test methods within a well established regulatory framework.
An inhaled generic is a complex dosage form due to the combination of drug and device. This requires a detailed understanding of the interactions between device, drug and formulation, as well as advanced manufacturing and test methods, within an evolving regulatory landscape.
Martin Oliver, Vectura's SVP Generic Programmes, explains more about the challenges of developing generic Dry Powder Inhalers and why Vectura is uniquely placed to do so.
US market for inhaled products(1)
US respiratory inhaled generic market remains a significant opportunity with few current and projected competitors
Generic conversion for key inhaled maintenance classes(2)
(1) IQVIA SMART Q4 2017 data for inhaled classes in Asthma and COPD
(2) Q4 2017 IQVIA SMART data – defined as pMDI and DPI ICS, ICS-LABA, LAMAs and LAMA/LABAs and LABAs and newly launched triple formulations