Generics vs value-added medicines: A regulatory divide 

Generics and value-added medicines allow for much faster development versus new chemical entities. The development and approval process for value-added medicines also presents unique opportunities compared to generic medicines.¹ Generics are designed to be identical to existing branded products, with the same active pharmaceutical ingredients, dose, strength, and method of administration.² This approach supports a relatively straightforward approval process, focusing mainly on demonstrating quality and bioequivalence.³ 

In contrast, value-added medicines introduce changes and enhancements that can address unmet needs, benefitting both patients and healthcare providers.^1,4 This added complexity means that standard pathways used for generics aren’t always appropriate. Changes to formulation, dosing, indication, or combining drugs mean that more evidence is required to prove the medicine’s safety or efficacy.¹ 

Costs associated with new drugs vs existing options 

In terms of regulatory processes and considerations, value-added medicines fall in-between generics and new chemical entities. The process is more complex than the approval of generics but doesn’t require the extensive and costly research needed for new chemical entities. Therefore, it can be much faster to get approval for value-added medicines versus new chemical entities. 

A recent article on the population-health impact of new NICE-recommended drugs reported that, between 2000 and 2020, the use of new drugs led to an estimated extra cost to the NHS of £75.1 billion.⁶ The authors predicted that health benefits to patients would have been higher if NHS resources had instead been spent on existing treatments and services.⁶ This research highlights the importance of cost-effective healthcare solutions utilising existing treatments. 

Regulatory pathways for value-added medicines: EU vs US 

The regulatory routes for value-added medicines differ significantly between the European Union (EU) and the United States (US).⁵ 

In the EU, multiple regulatory routes can be used for value-added medicines: 

• Article 10(3):⁷ This route can be used when the definition of a generic is not met, bioequivalence cannot be determined, or in cases where the active substance, indication(s), strength, pharmaceutical form, or administration route is changed versus the reference product. In this case, the results of pre-clinical tests or clinical trials are required 

• Article 10a:⁷ This route can be used when the active substance has been in well-established use for at least 10 years. It requires a clear connection between the existing product and the value-added medicine, and extensive literary support in place of pre-clinical tests or clinical trials 

• Article 10b:⁷ This is specific for new combination products, when patients transition from monotherapy or when the combination is used as an initial therapy. Pre-clinical tests or clinical trials relating to the combination are required 

• Article 8(3):⁷ Although primarily for new chemical entities, this route can be used for value-added medicines with the support of pharmaceutical tests, pre-clinical tests, and clinical trials 

The US utilises the 505(b)(2) pathway, which is more streamlined.⁵ This pathway is specifically for medicines with similar active ingredients to approved medicines, but with changes to formulation, dosing regimen, administration route, or a different indication,⁵ simplifying the approval process for value-added medicines.  

The role of healthcare professionals and patients 

Engaging patients and healthcare professionals early is important both to identify their unmet needs and ensure that value-added medicines are developed to address these where possible. This is crucial in driving positive health outcomes.⁴  

The perspectives of key opinion leaders and patient advocacy groups are key in the regulatory journey of value-added medicines, ensuring that the product addresses a gap in the therapeutic landscape. A patient-centred value assessment approach to value-added medicines has also been recommended,¹ which highlights the importance of patients’ and caregivers’ perspectives.  

Colonis integrates innovation and regulatory requirements 

At Colonis Pharma Ltd, we’re dedicated to developing value-added medicines that meet patients’ needs and conform to regulatory requirements. Our approach includes: 

• Identifying areas for improvement, for example, a more convenient method of administration or a repurposed therapeutic use 

• Conducting thorough research, documenting the unmet need, dosage considerations, clinical pharmacology, efficacy and safety data of reference products, and a summary of the benefits and risks to submit to the Medicines and Healthcare products Regulatory Agency (MHRA) and EU regulatory authorities 

The regulatory landscape for value-added medicines is complex and requires a deep understanding of both scientific innovation and regulatory frameworks. By understanding the key processes and keeping patient needs at the centre of our product development, we can successfully bring these enhanced medicines to market. 

References 

Colonis Pharma Ltd is an independent entity under the Clinigen Group.  

March 2025 | GB-CPL-0-186  

© Colonis Pharma Limited 2025 

Registered in England & Wales No. 05486832. VAT Registration No. 862418028. Registered office: Colonis Pharma Ltd, 25 Bedford Square, Bloomsbury, London, WC1B 3HH.