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.

In today’s fast-paced society, maintaining a healthy diet has never been more relevant. Nutraceuticals, or health supplements, are becoming increasingly popular for their role in maintaining overall health and supplementing nutrients lacking in our daily diets. These products are typically derived from natural and organic sources, catering to growing interests in areas such as immunity, joint support, sports nutrition, and heart health. Additionally, immunity boosters, cholesterol-lowering agents, fish oil, skin and hair-strengthening supplements, collagen supplements and fat-burning supplements are some of the highest-selling products in the market. 

Yet, the absence of unified regulations in certain aspects, such as labelling, might complicate product marketing across ASEAN countries and limit consumer access. In this article, we will delve into the complexities of complying with multiple local protocols while highlighting the importance of product safety and market entry.

  • Harmonised Standards

In 2004, the ASEAN Economic Community established the Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) to unify technical requirements for nutraceutical or health supplements and traditional medicines across the region. The group developed ten core annexes or technical requirements essential to harmonisation efforts. However, these have yet to be fully implemented as they require the ratification document to be signed by ASEAN trade ministers.

ASEAN Harmonised Technical Guidelines and Standards for Health Supplements

  • Annex I– ASEAN Guiding Principles for Inclusion Into or Exclusion From the Negative List of Substances for Health Supplements
  • Annex II– ASEAN Guiding Principles for the Use of Additives and Excipients in Health Supplements
  • Annex III – ASEAN Guidelines on Limits of Contaminants for Health Supplements
  • Annex IV – ASEAN Guidelines for Minimising the Risk of Transmission of Transmissible Spongiform Encephalopathies in Health Supplements
  • Annex V – ASEAN Guidelines on Stability and Shelf-Life of Health Supplements
  • Annex VI – ASEAN Guiding Principles on Safety Substantiation of Health Supplements
  • Annex VII – ASEAN Guidelines on Claims and Claims Substantiation for Health Supplements
  • Annex VIII – ASEAN Guideline on Good Manufacturing Practice for Health Supplements
  • Annex IX – ASEAN Guidelines on Labelling Requirements for Health Supplements
  • Annex X – ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements

Despite this, countries like Singapore, Malaysia, Brunei, Thailand, and Myanmar have begun adopting these standards, especially for the inclusion or exclusion of substances on the negative list. Though yet to be ratified, they provide a uniform framework, simplifying approvals and facilitating market entry. Adherence ensures products meet safety and quality criteria, which is crucial for consumer confidence and market success.

  • Registration Process

Registering a nutraceutical product in the ASEAN region usually involves several steps, which can vary slightly from country to country. Typically, this includes submitting detailed product information, safety data, and efficacy studies to the relevant regulatory authority. Despite these variations, all countries stress the importance of thorough documentation and adherence to local regulations. Understanding these steps enables companies to plan effectively and prevent delays in the registration of pharmaceutical products and dietary supplements.

  • Labelling Requirements

Among the many regulations to follow, labelling stands out as one of the most crucial aspects. Mandatory information often includes the product name, the name and strength of the active ingredients, usage instructions, and any necessary warnings. Labels must be clear, accurate, and in the appropriate languages used in the countries where the product will be sold. Adhering to these guidelines when introducing nutraceuticals into the ASEAN region makes sure that consumers receive the necessary information for safe and effective product use.

For detailed labelling requirements, refer to the ASEAN guidelines on labelling requirements.

  • Permissible Ingredients

Furthermore, each ASEAN country maintains a list of approved ingredients for nutraceutical products, aligned with ASEAN guidelines that determine which substances are permitted or restricted. These lists often impose restrictions on certain substances for safety and efficacy reasons. Companies must stay informed about these lists and verify that their products comply with regulatory standards by avoiding prohibited ingredients. This vigilance not only helps minimise regulatory risks but also certifies that the products are safe for consumers.

Read more: ASEAN Guiding Principles for Inclusion Into or Exclusion from the Negative List of Substances for Health Supplements.

  • Market Access Challenges

Gaining market access in the ASEAN region involves navigating diverse regulatory requirements and addressing local market conditions, which can pose significant challenges. Companies often encounter hurdles such as varying approval timelines, different documentation requirements, and cultural nuances affecting product acceptance. Overcoming these challenges requires strategic approaches such as conducting thorough market research, collaborating with local regulatory specialists, and remaining flexible to adapt to evolving procedures and market dynamics.

woman consuming a vitamin capsule compliant with pharmaceutical product registration

Navigating nutraceutical regulations in the ASEAN region requires a thorough understanding of the factors listed above. With the right insights and the support of regulatory affairs services, you can ensure compliance and successfully enter the ASEAN market. If you need guidance, consider reaching out to The Reg Consultants in Singapore. Our team offers comprehensive services to help you achieve regulatory compliance.

Contact us today to explore how we can support your market entry into the ASEAN region.