Needlestick Injuries and Safety Mechanisms Are Being used in Modern Prefilled Syringes
Prefilled syringes were first launched in the 1970s and since then have undergone considerable changes. As such products continue to evolve each year, regulations and laws governing the various aspects of these devices, such as design, development, manufacturing, and approval, are also being improved . Moreover, these laws and regulations vary in different regions of the world. Prefilled syringes are considered as combination products rather than just container closure systems for small molecule drugs and biologics. Therefore, they are regulated under the provisions of pharmaceutical or device legislation around the world. Therefore, it becomes very important for prefilled syringe manufacturers to understand and develop the necessary expertise to comply to the regulatory environment of the target market(s) in order to achieve commercial success.
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The regulatory environment for market authorization of prefilled syringes varies across different countries, such as the US, EU, Canada, Latin America (Brazil, Mexico and Argentina), Asia Pacific (Australia, Japan, China, India and South Korea) and the Middle East (Saudi Arabia and UAE). Amongst all the aforementioned countries, combination products are considered as separate product entities (in addition to drugs and devices) only in the US. They constitute a combination of any two or more medical products. Like all other medical products, combination products are also regulated by the FDA. In fact, a separate regulatory body, called the Office of Combination Products has been formed in the US to coordinate and streamline the regulatory life cycle of such combination products. According to the FDA, the products that are categorized as combination products include:
- Single entity, where two or more components are physically, chemically, or otherwise combined to produce a single entity.
- Co-packaging, where two or more separate entities are packaged together in a single package.
- Cross-labelling, where two or more components are packaged separately, but are intended to be used together or in combination for intended use, indication, or effect.
- The prefilled syringes market has witnessed impressive growth post their introduction. They are now a primary container of choice for parenteral mode of drug administration
- Prefilled syringes market size – One of the key objectives of the report was to evaluate the current market size and the future opportunity within the prefilled syringes market.
The FDA may apply drug or device regulations or both to regulate / approve a drug-device combination product. The agency follows certain guidelines to decide the regulations to be applied on a particular combination product and are handled on a case-by-case basis. However, an uncertainty on how to apply these regulations still remains. This is referred to as downstream issues.
In most of the above-mentioned countries, the approval pathway (either as drug or device) for the combination product is determined on the basis primary mode of action (PMOA). The PMOA for prefilled syringes is the therapeutic effect of the drug, therefore, in most of the countries such syringes are considered as medicinal products and are allocated to regulatory centers that review and approve drugs. However, in some countries, such as South Korea, India and Argentina, regulations related to combination products are not well defined.
Figure given below, summarizes the regulations related to prefilled syringes across different geographies. The report further features an informative summary of various guidelines established and issued by major regulatory bodies for the approval of prefilled syringes, across different countries / geographical regions.
Most self-injection devices / systems, such as autoinjectors and pen-injectors, rely on prefilled syringes, which serve as primary drug containers in the aforementioned products. Moreover, despite having been in the market for more than three decades now, the overall interest in prefilled syringes continues to grow. In fact, the recent increase in use of biologics, which are usually administered via parenteral routes, has had a significant impact on the demand for prefilled syringes. This is primarily due to reason that, prefilled syringes have been the container of choice for many biologic molecules, including monoclonal antibodies (mAbs) and vaccines. Some factors responsible for this preference include:
- Most biologics require parenteral administration
- Biologics are costlier than pharmaceutical drugs and packaging of biologics in prefilled syringes reduces overfills, saving costs
- Prefilled syringes allow product differentiation
- Ease of use and ability to save time helps to deploy vaccines in mass immunization programs
- Ease of use allows self-administration of drugs for chronic conditions
As mentioned above, in addition to end-users, prefilled syringes also offer several advantages to manufacturers. However, some technical issues, such as functionality issues and syringe siliconization, are yet to be addressed to ensure better compatibility between the drug and the device. It is worth highlighting that development of biologics in combination with prefilled syringes has garnered a lot of interest in the biopharma industry.In the last few years (2013-2019), close to 90 drugs have been approved in combination with prefilled syringes. Humira®, Rituxan®, REMICADE®, STELARA®, Enbrel®, GARDASIL® and PREVNAR 13® are examples of some of the blockbuster drugs (with annual sales of more than USD 5 billion) that are being extensively administered via prefilled syringes.
Prefilled syringes market growth – We are seeing an increased demand in the emerging markets, particularly within the BRICS nations, namely Brazil, Russia, India, China and South Africa.
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