Legal & Regulatory > Indonesia > Biosimilars & Biologics

The key facts about biosimilars and biologics in Indonesia. Prepared in association with ABNR, a leading global law firm, this is an extract from The Pharma Legal Handbook: Indonesia, available to purchase here for GBP 99.

1. Are biosimilar medicines considered the same as generic medicines in your country?

No. Head of BPOM Regulation No. 17 of 2015 on Guidelines for Assessment of Biosimilar Products (“BPOM Reg 17/2015”) defines Biosimilar Product or Similar Biotherapeutic Product as a biological product with similar efficacy, safety and quality profiles as the approved biological product. The regulation explains that in contrast to chemically synthesized generic drugs, biosimilar products are extremely complex, intricate, and go through very specialized manufacturing processes. Thus, the assessment of a biosimilar product cannot be equated with synthesized generic drugs.

2. Are all biologic medicines, including biosimilar medicines, patentable in your country?

Biologic medicines are generally patentable in Indonesia insofar that they comply with the criteria under the Patent Law. A patent can be granted to an invention that fulfils the following criteria:

• original, meaning that as of the date of registration the invention is different to any technology that has been disclosed;
• contains inventive steps, meaning that the invention has not been predicted by persons with the relevant technical skills. For a simple patent, the invention must be an improvement of the existing product or process and has practical use; and 
• is applicable to industry.

Patent cannot be granted to the following:

• a process or product whose announcement, use, or implementation is contradictory to legislation, religion, public order, or morality;
• methods of examination, treatment, medication and/or surgery applied to humans and/or animals;
• theory and methods in the field of science and mathematics;
• living entities, except microorganisms; or
• biological processes that are essential for producing plants or animals, except for nonbiological processes or microbiological processes. 

Although not specifically exempted from patentability under the Patent Law, biosimilar medicines may not fulfil the ‘originality’ or the ‘inventive’ criterion, as they have the same properties as their originators.

3. Is there a specific regulatory framework for the marketing authorization of biosimilar medicines in your country? If yes, what is the regulatory framework for the authorization of biosimilar medicines?

No, the same regulatory framework for marketing authorization applies to drugs, biologics, and biosimilars. The authorization is primarily stipulated under: (i) MOH Regulation No. 1010/MENKES/PER/XI/2008, as amended by MOH Regulation No. 1020/MENKES/PER/XII/2008 on Drug Registration; (ii) MOH Regulation No. 14 of 2021 on Business Activities and Products Standards for the Implementation of Risk-Based Business Licensing in the Health Sector; (iii) BPOM Regulation 24/2017; and (iv) BPOM Reg 10. The only difference is the assessment criteria and procedure during the application process – for biosimilars, these are currently regulated under BPOM Reg 17/2015. 

4. What kind of data package is needed to obtain approval for a biosimilar drug? Is this any different to the requirements for the original Biologics drug?

As with original biologics drugs, the authorization process for a biosimilar drug comprises pre-registration and registration phases. In each phase, the applicant must submit documents containing specific data as referred to under BPOM Regulation 24/2017 and BPOM Reg 10. For example, quality documents (e.g., information on manufacturing process and source of active ingredients), non-clinical documents (nonclinical overview), clinical documents (clinical overview). 

Specific for biosimilars, BPOM Reg 17/2015 also requires the applicant to carry out certain evaluations, such as a comparability study, in which a comprehensive physicochemical and biological characterization of the biosimilar product in a head-to-head comparison with the comparator product must be performed. The applicant must also provide scientific evidence to justify the selection of comparator product, with special attention to quality aspects.

5. What are the requirements for the choice of the reference comparator product?

BPOM Reg 17/2015 defines a comparator product as a biological product used in direct comparison (head-to-head) with biosimilar products in the comparability test to show similarities in terms of quality, safety and efficacy.

The selection of comparator product for comparability studies should be based on the following principles:

• The active substance of a biosimilar product must be similar (both molecular and biological effects) with the active substance of the comparator product that has been approved for circulation in Indonesia;
• The selected comparator product must be used as a reference in all comparability studies for aspects of quality, safety, and efficacy, in order to produce coherent data and conclusions;
• The dosage form, strength and method of administration of the biosimilar product must be the same as that of the comparator product;
• Where there is a difference between the biosimilar product and the comparator product, the difference should be justified by appropriate studies on a case-by-case basis. Consideration of the safety factor is prioritized.

6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?

Yes, although locally sourced comparator products should be prioritized.

BPOM Reg 17/2015 stipulates that the comparability test of biosimilar products should to the fullest extent possible use a comparator product that has been approved in Indonesia. However, if this is not possible, the selection of comparator product can be made based on the following criteria:

• The originator product does not exist in Indonesia
  • If the originator product is not available in Indonesia, it is necessary to first look at the distribution status of the originator product. If the originator product has been approved in countries with established evaluation systems, it can be used as a comparator product. However, if the originator product has been rejected for registration in Indonesia, the reason for the rejection must first be reviewed. If the reason for the rejection of the originator product is related to aspects of quality, safety and efficacy, the product cannot be used as a comparator product.
• The manufacturer of the originator product no longer produces the originator product
  • If the originator product’s manufacturer no longer produces the originator product, the comparator product used is the most established biological product. Biological products that are declared the most established are those that have been approved based on complete data on quality, safety, and efficacy, and have been circulating for a long time without any issues related to quality, safety and efficacy aspects.

The comparability of the biosimilar product with the selected comparator product should be discussed, both the final drug product and the active substance. The patent name, dosage form, formulation and dosage quantity of the comparator product must be clearly identified, including a discussion on the half-life of the comparator product against the quality profile. In order to ensure that the molecular structure of the biosimilar product can be compared with that of the comparator product, proper comparability studies of the active substance must be carried out. The contamination ratio should also be considered. In cases where an analysis of the quality aspects of the active substance of the reference product can be carried out at the final product stage, testing of the isolated active substance may not be necessary.

The applicant must demonstrate, using a reliable method of analysis, that the active substance used in the comparability study is representative of the active substance in the comparator product. If the analytical method cannot compare the active ingredients of the biosimilar product, the applicant must adopt another suitable approach to obtain a representative active substance from the comparator product and then carry out a comparative analysis. This approach must be properly validated to demonstrate the suitability of the sample preparation process, including comparative tests and data on the active substance of the comparator product.

7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?

No difference. The applicant is required to submit pricing for each packaging (to the smallest packaging) that will be applied across the territory of the Republic of Indonesia during the registration process to obtain MA.

8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?

Similar to biologics drugs, there is no regulation on reimbursement of biosimilar medicine in Indonesia. The Indonesian Government, however, manages a public healthcare system via an independent authority (known as Health BPJS). 

Anyone, regardless of whether they already have another health insurance policy, is obligated to become a participant in the health security program managed by the Health BPJS. It will charge members periodical contribution fees. The Indonesian Government will provide contribution aid to the Health BPJS as an additional source of funding for the purpose of sponsoring those on low incomes so that they can be covered by the health security program.

The Health BPJS will cover health services expenses of its participants in accordance with the health security program regulations.

9. Does biosimilar competition impact the reimbursement policy of the originator reference products?

No.

10. What is the legal framework for biosimilar medicines prescribing (clinical decision maker) and dispensing (pharmacy level, hospital or retail)? Is this any different to the requirements for the original Biologics drug?

There is no specific legal framework for prescribing and dispensing biosimilars. The same regulations that apply to drugs and biologics also apply to biosimilars. Prescribing must always be done by licensed doctors. Only licensed pharmacists are allowed to dispense prescription drugs, biologics, and biosimilars.

11. Is the system considering physician-led switching and/ or pharmacy-level substitution (without involvement of the clinical decision maker)?

No.

12. What are the post-authorisation requirements (including pharmacovigilance, risk management plans, post-approval studies) for biosimilar medicines? Is this any different to the requirements for the original Biologics drug?

Pharmacovigilance is part of the process for authorization of biosimilars. BPOM Reg 17/2015 stipulates that as existing technology has not been able to specifically identify the differences between biosimilar products and their originators, producers of biosimilar products must carry pharmacovigilance studies. The applicant must submit safety specifications and pharmacovigilance plans at the time of application for MA.

The post-distribution safety report must contain all information about the tolerability of the product approved by the BPOM. Safety information should be scientifically evaluated and should include an evaluation of the frequency and causality of unwanted effects.

13. Are there specific policies and requirements for labelling biosimilar medicines in the event of second medical use patents? Is this any different from the requirements for the original Biologic drug?

There are no specific policies and requirements for biosimilars labelling in the event of second medical use patents. The same regulations that apply to drugs and biologics also apply to biosimilars. BPOM Regulation 24/2017 provides a comprehensive list of minimum information that must be contained in each type of labeling.

Please note that second medical use of biologics and biosimilars is not patentable under Indonesian law. Article 4(f) of the Patent Law stipulates that a patentable invention does not include: (i) discovery of new use of an existing/known product; and/or (ii) a new form of an existing compound that does not offer a significant increase in efficacy and there are already known differences in the associated chemical structure of the compound.

14. Have there been any significant legal/judicial developments in relation to biosimilars in your country? (Including but not limited to IP, procurement, competition, misleading information campaign, access to reference comparator product)

None that we are aware of.

15. Are there proposals for reform or significant change to the legal, regulatory, procurement of biosimilars? If yes, when are they likely to come into force?

None that we are aware of. We spoke with an official at the BPOM in May 2021 and were told that the BPOM currently has no plan to issue a new regulation on biosimilars.