Novugen

Suci Ameliya Reza Zairizal

Ageneric 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.

It sounds so easy to produce copycat products with all available information, but every year new drugs emerge, and generic makers cannot rely on the old molecules to sustain the business. New drugs are getting more complex, and it has become difficult to ensure the bioequivalence of generic products to the innovator product. Take Pentasa Extended-Release Capsules as an example, the product was approved by US FDA in 1993 and only after almost 30 years the first generic was approved in 2022. A few hundred failed bioequivalent studies were reported and so much money was invested in the development of this product.

 Moreover, new manufacturing technologies were introduced by innovators; then again, generic makers are struggling to utilize the available technology in developing drug products with bioequivalent. And often, only big pharma companies with deeper pockets and greater buying power can easily obtain the technology. 

A shortage of raw materials and specialized equipment can stifle development progress. As more and more complex and specific drugs are created, there’s a higher chance of limited raw materials required. Generic developers must use several sources of API and functional excipients during development to avoid disruption of supply prior to commercialization. Often, when the formulation is finalized, the bioequivalent completed, and the product is about to be registered, API manufacturers are informed that they are unable to supply the material anymore. This will hinder the possibility of becoming the first in the market after the innovator's product and claim the exclusivity profit. Effective strategic sourcing and operating a lean organization is the only way out since generics must contain the same API and effectiveness as the innovator.

Moreover, innovator companies have changed their strategies to focus their market on developing nations by acquiring big generic manufacturers and diverting their R&D work to emerging markets due to low-cost, high-skill manpower. The trend of innovator companies launching their patented products as well as branded generic products acquired from domestic players in various countries has become a norm that greatly affected generic companies.

Generic drug product manufacturers must revise their strategy to survive in the competitive market and deliver affordable medicines to patients. They can no longer rely on the R&D of new generic products alone but start investing in innovation of higher value generics. In addition, the supply chain through middlemen shall be redesigned to reduce dependency on raw material suppliers and help secure the supply chain in times of volatility. Apart from that, mergers and acquisitions can be considered to become bigger and better that, increase scale to allow more effective negotiation with potential customers.