September 2023 • PharmaTimes Magazine • 23

// GENERICS //

Same to you

The vital innovation and development of generic pharmaceuticals

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Generic drugs are crucial, not only for their effectiveness, but also for their cost-saving potential for both manufacturers and customers. Bachem – a Swiss pharmaceutical company – is leading the way with a multidisciplinary approach that enhances commercial success while minimising risk.

Generics are drugs that are designed to replicate the original branded drug. They are the same as branded drugs in terms of dosage, strength, administration, quality, performance and intended use. The same active pharmaceutical ingredients (APIs) must be used in generic drugs as their branded counterpart.

Once the patent of a brand-name drug expires, generic drugs are able to enter the market. Essentially, generics are virtually identical to the brand-name version, being just as effective and offering the same benefits.

Generics aren’t simply carbon copies of brand-name drugs: a great deal of complex research, testing and compliance goes into the creation of generics.

Game changers

Generic drugs are important as they make medication much more accessible to the wider population. The safe and effective alternatives to brand-name drugs are extensively used, with a significantly reduced cost. Healthcare customers are able to access high-quality products within budget, boosting the effectiveness of the healthcare system.

Generic drugs are becoming increasingly popular, with most brand-name drugs having a generic counterpart.

Bringing more drug competition into the market in the form of generics will address the problem of high-cost branded medications, making it a top priority.

Brand new

Generic drugs tend to be less expensive as they don’t cost as much to develop. This is because brand-name medications are new drugs that require research, development and clinical trials. These new discoveries undergo years of human and animal testing before being deemed safe and effective drugs.

Brand companies then get exclusivity and patent protection to ward off competition from generic drugs for several years, meaning these branded drugs are sold at a higher price point to compensate the makers for their initial costs.

Generic drugs still undergo rigorous research and testing, but clinical studies are no longer required, as the drug is essentially the same. The lower costs mean that generic drugs can be sold at a much more accessible price point.

Creating generics isn’t as simple as copying the existing branded drug. Making generics requires the mastery of a whole host of different skills, including the legalities of acquiring new products, regulatory support, research and manufacturing, along with a strong distribution network. There is no room for inefficiency when developing generics as products need to be delivered at the right time, with the right price, while being 100% safe and effective.

The challenges that come with creating generics vary across risk, regulatory and compliance issues, which is why a comprehensive approach to developing APIs is a requirement.

Bachem manufactures some of its own materials, providing generic APIs with a safe and sustainable supply chain, thus minimising the risk of creating generics without support.

Final analysis

A generic drug can be a better option for many, predominantly due to the cost factor. Generic drugs are much more accessible to all budgets in comparison to their branded counterparts. Low-cost generics have been shown to have better health outcomes as patients are more likely to take their prescribed medicines without the cost being a concern.