Have you ever encountered the terms “biosimilar” and “generic drugs” and wondered what the difference 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.

Definition and Development

At first glance, biosimilars and generics seem similar as both provide affordable alternatives to established medications. However, a major difference 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. Biosimilars are a different type of drug. They are biologics derived from living sources, such as plant or animal cells, making their structures more complex and less defined. Due to this, creating an exact copy of a biologic is impossible, and differences have an impact on their efficacy level; hence, having an established comparability study of the reference product is essential to minimise the risk. 

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. 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. Biosimilars undergo a more rigorous assessment to establish high similarity to the reference product (the original biologic) in quality, safety, efficacy, and biological activity. This often involves extensive analytical studies and clinical trials.

Efficacy and Safety

In regulatory assessments, both biosimilars and generics must demonstrate efficacy and safety. Biosimilars need to show that they are not just effective but also safe, matching the profiles of the reference product. Meanwhile, generic drugs, while identical in active ingredients and dosage to brand-name drugs, must prove bioequivalence through pharmacokinetic studies to confirm they work just as well and are equally safe.

Market Access and Affordability

The introduction of biosimilars and generics has had a significant market impact, improving healthcare access and making medications more affordable for everyone. These drugs, typically priced lower than their brand-name counterparts, offer substantial cost savings. This affordability allows healthcare institutions to stretch their budgets further, ultimately enabling them to treat a larger number of patients.

Physician and Patient Considerations

While biosimilar and generic drugs offer significant benefits, healthcare providers need to weigh certain important considerations. For example, although biosimilars provide alternatives to brand-name biologics, they are not always interchangeable with the reference product. The decision should be made in consultation with a qualified healthcare professional who can evaluate the patient’s specific needs and medical history.

Female doctor hand holding pack of different tablet blisters

Understanding the regulatory framework for biosimilars and generics empowers stakeholders during the registration process. Recognising the distinct development and approval pathways, along with considerations for efficacy, safety, and affordability, helps them make informed decisions that benefit both patients and the healthcare system as a whole.

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.

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/ 

Get in touch with us today to find out how we can tailor our services to fit your needs.