DECEMBER 20248LIFE SCIENCES REVIEWIn My OPINIONGENERIC DRUG PRODUCTS DEVELOPMENT ­ CHALLENGES AND OVERVIEWBy Suci Ameliya Reza Zairizal, Associate Manager, Novugen generic drug product is a medication that was created to have the same dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use as the original product. Developing generic drug products requires a scientific and technical approach which is totally different from developing original products or innovator products. Developing innovative product require a huge amount of investment and this is one of the main reasons most of the developing countries focus on developing a generic drug. Depending on the target market, generic products will be developed with different strategies as different markets have different requirements. The development process involves several stages, such as literature review, pre-formulation study, formulation development, manufacturing process development, container closure system development, scale-up batches, and bioequivalence study. Depending on the regulatory agency, it will take at least 12 months to get the product registered. Development time of generic products normally will take a minimum of three years, depending on the complexity of the product.Though the development of generic drug products does not require that much time and cost compared to the innovator, it is very difficult to develop a product with the same therapeutic efficacy and to meet all the regulatory requirements, while the profit is uncertain considering many aspects. The first generic drug products, when they first hit the market, are priced at a premium but slightly below the innovator price. However, when the competitors enter the market, prices decrease further. Therefore, from the initial development stage, raw materials must be sourced strategically because the main cost of the product is from the raw materials cost. Generic product makers must be creative and work hard to communicate their product's capabilities and unique qualities rather than spending costs for extensive marketing promotion.A
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