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Understanding the Regulatory Framework Differences for Biosimilar and Generic Drugs


Have you ever wondered what the difference between the terms “biosimilar” and “generic drugs” is? In the pharmaceutical industry, the distinctions between biosimilar and generic drugs play an important role in affecting healthcare accessibility and affordability, particularly in the context of pharmaceutical product registration. This guide explores the contrasting regulatory frameworks for biosimilars and generics, their development and approval processes, and their impact on the healthcare industry.

Biosimilar drugs are highly similar to biologic drugs, which are derived from living organisms. While they are not identical to the original biologics, they are designed to match the reference product in terms of quality, safety, and efficacy. Due to the complexity of biologics, biosimilars require rigorous testing and regulatory approval. The difference between biosimilar and generic drugs lies in the nature of the original products—biologics versus chemically synthesised drugs.

Generic drugs are chemically equivalent to brand-name drugs and contain the same active ingredients, dosage, and efficacy. They are generally more affordable as they do not require the same extensive testing as the original branded drug, focusing instead on proving bioequivalence. The difference between biosimilar and generic drugs lies in the fact that generic drugs are simpler, chemically synthesised versions of brand-name pharmaceuticals, whereas biosimilars are derived from biological sources.

Definition and Development

At first glance, biosimilars and generics seem similar as both provide affordable alternatives to established medications. However, a major difference between biosimilar and generic drugs lies in their origin and the regulations governing their development.

Generic drugs are exact copies of small-molecule brand-name drugs, where the manufacturing process can be precisely replicated. These drugs contain identical active ingredients, dosages, and formulations, allowing them to be approved through a more straightforward regulatory process, focused on proving bioequivalence. This means that the generic drug delivers the same amount of active ingredient into the bloodstream as the original, ensuring similar therapeutic effects.

Biosimilar drugs, on the other hand, are biologics derived from living sources, such as plant or animal cells, making their structures more complex and less defined. Because of their biological nature, creating an exact copy of a biologic is impossible. As a result, biosimilars require a more rigorous approval process that involves comparative studies to demonstrate that they have no clinically meaningful differences in safety, efficacy, and biological activity from the reference product. The difference between biosimilar and generic drugs is primarily based on their complexity and the necessity for comprehensive comparability studies in biosimilars.

Approval Process

The governing regulatory authority in Singapore for health products is the Health Sciences Authority (HSA), which plays a vital role in verifying the safety and efficacy of both biosimilars and generics. Nevertheless, the registration process for each category differs due to the difference between biosimilar and generic drugs.

Generic drugs typically follow a well-established pathway that focuses on demonstrating bioequivalence, meaning the drug delivers the same active ingredient to the body as the original. In contrast, biosimilars undergo a more rigorous assessment to establish a high level of similarity to the reference product (the original biologic) in terms of quality, safety, efficacy, and biological activity. This often involves extensive analytical studies and clinical trials, reflecting the more complex nature of biologics.

Efficacy and Safety

In regulatory assessments, both biosimilars and generics must demonstrate efficacy and safety. However, the difference between biosimilar and generic drugs lies in their approval process. While generics must prove bioequivalence to a brand-name drug, biosimilars must establish their similarity to the biologic reference product by matching its safety and efficacy profile through comprehensive testing.

Market Access and Affordability

The introduction of both biosimilars and generics has had a significant impact on the pharmaceutical market. The difference between biosimilar and generic drugs is primarily their origin—biosimilars are derived from biologics, while generics are chemically synthesised versions of brand-name drugs. Both types of drugs offer substantial cost savings, and have greatly improved access to affordable healthcare.

Physician and Patient Considerations

While both biosimilar and generic drugs offer significant benefits, healthcare providers must carefully consider their interchangeability. The difference between biosimilar and generic drugs becomes crucial when deciding on treatments, as biosimilars may not always be substituted for the original biologic, unlike generics, which can often replace brand-name drugs without complications. The decision should be made in consultation with a qualified healthcare professional who can evaluate the patient’s specific needs and medical history.

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Understanding the difference between biosimilar and generic drugs helps healthcare providers and regulatory stakeholders navigate the approval processes. Recognising the distinct pathways for both categories ensures safe and effective medication options for patients.

For expert guidance on navigating the complexities of pharmaceutical registration in Singapore, consider partnering with a reputable consultancy firm like The Reg Consultants. Our team of regulatory specialists offers comprehensive pharma regulatory services and possesses in-depth knowledge of the local landscape for biosimilars and generics. We can guide you through the intricate approval process, ensuring your products meet all regulatory requirements.

Frequently Asked Questions

1. What is the difference between biosimilars and generic drugs?

The primary difference is that biosimilars are derived from biologic drugs, while generics are chemically identical to brand-name drugs. Biosimilars require more rigorous testing to prove similarity to biologics.

2. What is crucial for a biosimilar application in Singapore?

It is important to find out what is the Singapore Biological Reference Product so as to build comparative quality, PK and PD profile for registration.

3. What is the registration process for biosimilars in Singapore?

In Singapore, the registration process for biosimilars involves submitting a comprehensive application to the Health Sciences Authority (HSA) via the NDA-2 route and obtaining prior approval from reference agencies such as EMA, FDA, TGA. The application process typically takes about 230 working days.

4. Are clinical trials required for biosimilar registration in Singapore?

Yes, clinical trials may be required as part of the registration process for biosimilars in Singapore. The extent of required trials depends on the degree of similarity established through analytical studies and the specific characteristics of the biosimilar.

5. What documentation is needed for biosimilar registration?

The documentation needed for biosimilar registration typically includes a detailed dossier containing information on the manufacturing process, quality control measures, preclinical and clinical study results, and any other relevant information to support the application.

Please link to my articles that I have written previously:

Generic: https://theregconsultants.com/overcoming-the-challenges-of-registration-of-a-generic-drug-in-singapore/ 

Biosimilar; https://theregconsultants.com/quick-overview-of-biosimilar-registration-in-singapore/ 

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