Innovation and the development of generic pharmaceuticals

Published: 19-Apr-2023

Generic drugs are incredibly important in the medical field, 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 whilst minimising risk.

What are generics?
Generics are drugs that are designed to replicate the original branded version. 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. 

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

Why are generics important? 
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. 

Why are generic drugs cheaper?
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 require years of human and animal testing before being deemed to be 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. 

How to mitigate the challenges of generics
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, whilst 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. 

Why generics are a better choice for many
A generic drug can be a better option for many, predominantly because of 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. 

With medication affordability being such a prevalent issue, Bachem can provide the solution with their years of experience creating APIs for generics. This innovative approach is key to the success of any newly launched generic drug. 

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