The generic pharmaceutical industry in low- and middle-income countries sits at a significant crossroads. With a limited supply of locally made essential medicines, many countries in Africa and Asia are working to expand medical product manufacturing to improve access to quality-assured medicines for millions of patients and communities.
Quality generics play a crucial role in increasing access to affordable and effective treatment options for many health conditions. However, assuring the quality, safety, and efficacy of generic medicines, which can be achieved through bioequivalence (BE) studies, remains a critical issue.
While evolving global policies and funding shifts present uncertainties for the future of generic pharmaceutical manufacturing, there are also clear growth opportunities to build a more resilient supply of locally produced generic medical products across Africa and Asia.
More than 50 percent of people in Africa lack regular access to essential medicines, underscoring the urgent need to improve the availability of quality generic medicines.
What are BE studies and why they matter
Manufacturers of generic medicines must match the safety, efficacy, and quality of brand name products. To do so, clinical studies known as BE studies, are typically needed to ensure that no matter the product – brand name or generic – patients experience the same benefit and quality treatment.
In some limited cases, conducting clinical BE studies may not be required when, for example, the bioequivalence of a product is either self-evident based on its properties, or a product qualifies for a biowaiver, which allows for BE to be established based on other research data.
Unfortunately, in many low- and middle-income countries, BE study requirements are expensive for regional and local manufacturers to adhere to and difficult for regulators to enforce, raising concerns about quality and an over-reliance on foreign imports.
_____
Bettering the business case for bioequivalence studies in Africa
A guide for contract research organizations conducting BE studies.
Download the resource
_____
Challenges to increasing the demand for and availability of quality generics
Several regulatory, financial, and perception issues make conducting BE studies in low- and middle-income countries challenging. For example, some regulators don’t require BE studies at all, or only require BE studies for imported generic products, not generic products made locally. A lack of BE study requirements and variations in regulatory enforcement of locally produced versus imported generics contributes to challenges in assuring access to safe, quality generics and impacts public perception of generic products. The availability of locally produced generic medicines that haven’t met the appropriate BE requirements put patients at significant risk.
Manufacturers and regulators in markets that do not uniformly enforce BE study requirements often cite the prohibitive cost of BE studies and the absence of local organizations as key challenges. However, efforts to strengthen regulatory maturity may mean stronger regulatory enforcement and compliance with BE requirements.
Funding and capital constraints, including smaller markets that exist in low- and middle-income countries, are also important economic barriers since the cost of BE studies can vary from US$30,000 – US$300,000, depending on the study size and complexity.
In addition to these challenges which contribute to reduced demand for BE studies, other regulatory and logistical barriers affect local capacity to conduct BE studies including complex regulatory requirements, lack of regional harmonization, limited regulatory capacity, infrastructure issues, supply chain challenges, and few skilled personnel to conduct and oversee BE studies.
Manufacturers and regulators in markets that do not uniformly enforce BE study requirements often cite the prohibitive cost of BE studies and the absence of local organizations as key challenges.
Possible solutions
To improve the availability of quality generics, low- and middle-income countries must create an enabling environment where regulators and manufacturers have the capacity and resources to fulfil their obligations to require and conduct BE studies. Local contract research organizations (CROs), which specialize in conducting BE studies, can help to address economic and logistical barriers and provide the needed support to the local and regional pharmaceutical industry.
Local CROs also allow regulators to more easily understand and improve their ability to perform inspections, giving them confidence in evaluating submitted study data.
Establishing CROs to conduct BE studies will help ensure product efficacy, improve patient safety, increase local market share, and expand export potential for regional manufacturers.
Advancing regulatory maturity is another solution to increasing BE studies. BE study requirements and enforcement are necessary for those regulators working to achieve WHO Maturity Level 3 (ML3), the mark of a well-functioning regulatory agency.
By achieving ML3, regulators signal to manufacturers and CROs that they will require and enforce BE studies, creating both increased demand for BE studies from local and regional manufacturers and increased financial viability for BE centers. In addition, in Africa specifically, regional economic communities (RECs) and initiatives like the African Medicines Regulatory Harmonization (AMRH) program can help increase demand for BE studies through regulatory harmonization.
Expanding BE studies in Africa
Currently very few CROs in Africa have sufficient capacity to conduct BE studies and struggle to secure the initial financial investment required to become fully operational. But expanding the capacity of CROs to conduct BE studies on the continent can help reduce costs, improve access to quality generic medicines, and increase export potential with products that adhere to more stringent global requirements.
Yet despite these benefits, CROs across Africa face significant difficulties in implementing successful business models, building credibility to attract clients, generating sufficient revenue to maintain sustainable operations, meeting regulatory requirements, and obtaining necessary accreditation and approvals.
With support from the Gates Foundation, USP developed a resource guide for CROs to increase their capacity to conduct BE studies in low- and middle-income countries by helping them build better business plans. The resource guide includes market analysis, marketing and sales strategy, management and organization guidance, operations planning, and financial planning.
_____
Webinar: Building bioequivalence capacity through better business planning
How CROs in low- and middle-income countries can develop better business plans to conduct BE studies and expand manufacturing in Africa.
Watch the webinar
_____
Moving forward
Strengthening bioequivalence capacity and increasing access to affordable, quality-assured generic medical products requires a multi-pronged approach, including:
- Supporting established and emerging CROs in low- and middle-income countries to improve financial sustainability
- Assisting national regulatory authorities in providing better oversight of BE studies
- Strengthening manufacturers’ ability to comply with BE requirements
Specifically, increasing the number of national regulatory authorities that achieve WHO ML3 is key to expanding BE study requirements, improving CRO viability, reducing the number of generic medicines approved without establishing bioequivalence, and assuring equitable access to quality medicines in low- and middle-income countries.
Building on the work of USP and Gates Foundation, continued investment in and support for the development of CROs in Africa, Asia, and beyond is critical in creating expanded and distributed manufacturing capacity as part of a robust generic pharmaceutical manufacturing ecosystem driven by strong regulatory frameworks and capable CROs.
