Legal & Regulatory > Ukraine > Biosimilars & Biologics

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

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

No, in Ukraine, biosimilar medicines are not considered the same as generic medicines. According to the Order of the Ministry of Health of Ukraine “On Approval of the Procedure to Examining Registration Materials for Medicinal Products Submitted for State Registration (Re-registration) and also to Examining Materials on Amendments to Registration Materials during the Validity of the Registration Certificate” (the “Procedure on Examining Registration”)¹ No. 426 dated 26 August 2005, biosimilar medicines must be similar in its quality, efficiency, and safety to the referent biologic medicines. Meanwhile, generic medicines must have the same quality and quantity of the active substance and be of the same form as the referent medicine. The Ministry of Health of Ukraine (the “Ministry of Health”) in its Guidelines ² states that since bioequivalence cannot be established for biosimilar medicines, such medicines must undergo more detailed comparison.

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

The Law of Ukraine “On the Protection of Rights to Inventions and Utility Models” No.3687-XII dated 15 December 1993 (the “Law on inventions”)³ does not provide for the separate rules governing the patentability of any biologic medicines, including biosimilar medicines. Thus, the issue of patentability will be determined on a case-by-case basis according to three general criteria in the course of the qualification examination.

The National Intellectual Property Authority conducting the qualification examination examines the following criteria:

• Novelty;
• Inventive step;
• Industrial applicability.

Meeting the above criteria, the biologic medicines, including the biosimilar medicines, will receive a patent.

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, Ukrainian legislation does not envisage a specific regulatory framework for the marketing authorisation of biosimilar medicines, and the general procedure shall apply.

In Ukraine, the marketing authorisation of medicines is governed by:

• the Law of Ukraine “On Medicinal Products “No. 123/96-VR dated 4 April 1996 ⁴ (the “Law on Medicinal Products”), Art. 9 and Art. 91;
• the Resolution of the Cabinet of Ministers of Ukraine (the “CMU”) “On Approval of the Procedure of State Registration (Re-registration) of Medicinal Products and Fees for Their State Registration (Re-registration)” ⁵ (the “Procedure for State Registration of Medicinal Products”) No. 376 dated 26 May 2005;
• the Procedure on Examining Registration etc.

According to the Procedure for State Registration of Medicinal Products, biosimilar medicines must be registered with the Ministry of Health to be placed on the market in Ukraine. The registration is conducted based on the application and results of the examination of registration materials for medicines. Furthermore, the Procedure on Examining Registration establishes specific requirements for the content of the registration dossier of biosimilar medicines.

Upon completing registration, the applicant receives a registration certificate for the medicinal product with a validity period of five years. Medicines placed on the market during the five-year validity period are allowed for use until their expiry term indicated on the packaging. After the expiry of the five-year initial registration term, medicines shall be re-registered. After re-registration the medicines may be placed on the market for an unlimited period.

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?

The data package needed to obtain the approval is the same for biosimilar drugs and original Biologics drugs and comprise:

• registration dossier materials;
• materials regarding the control methods of medicine product quality;
• information regarding the production technology and a copy of the official production certificate issued by the authorized body of the state of production;
• text of package labelling;
• a certified copy of the State Service of Ukraine on Medicines and Drugs Control (the “SSM”) document conforming that production conditions meet the GMP requirements;
• confirmation of the registration fee payment.

Although the above data package is uniform required for approval for all medicines, the Procedure on examining registration establishes specific requirements for the content of the registration dossier of biosimilar medicines, since resalts of comparability examinations of biosimilar and original medicines must be reflected in the biosimilars registration dossier.

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

No specific requirements for the choice of the reference comparator product are envisaged in the Ukrainian legislation. According to the Procedure on Examining Registration, the selected reference comparator product must be a medicinal product registered in the world for the first time based on the full dossier, as an innovative product. The referent product used for all forms of comparability analysis must be of the same source majorly registered in the country with a tough regulatory system.

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

Yes, the reference comparator product can be sourced from another regulatory jurisdiction as long as it meets the above description of the comparator product. The Procedure on Examining Registration specifies that if the reference product is sourced from another country additional information such as the maintenance of the cold chain during the transportation is required.

However, the exact scope of the required additional data is not established. According to the general rule prescribed for biosimilar medicines, the type and scope of the additional data are defined on a case-by-case basis under the principles laid down in the EMA Guidelines and the Ministry of Health Guidelines.

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

Prices on biosimilars and original Biologics drugs are covered by the general regulation of pricing of medicinal products. The following acts are applicable:

• The Law of Ukraine “On Prices and Pricing” No. 5007-VI dated 21 June 2012;⁶
• The CMU Resolution “On Measures to Stabilise the Prices for Medicinal Products and Medical Devices” No. 955 dated 17 October 2008;⁷
• The CMU Resolution “On Certain Issues of State Regulation of Prices for Medicines and Medical Devices” No. 333 dated 25 March 2009;⁸
• The CMU Resolution “The Issues of Declaration of the Change of the Wholesale Prices for the Medicinal Products” No. 240 dated 2 July 2014;⁹
• The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products under the Program of State Guarantees of Medical Care of the Population” No.854 dated 28 July 2021;¹⁰
• The CMU Resolution “On Governmental Regulation of Prices for Medicinal Products” No. 862 dated 9th November 2016;¹¹
• The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products” No. 135 dated 27 February 2019;¹²
• The Order of the Ministry of Health “On Adoption of the Rules on the Register of Wholesale Prices for Medicinal Products and Medical Devices, the Rules of its Change and the Forms of Declaration of the Change of the Wholesale Prices for Medicinal Products and Medical Devices” No. 574 dated 18 August 2014;¹³
• The Order of the Ministry of Health “On Adoption of the Rules of Calculation of Marginal Wholesale Prices for Medicinal Products Based on the Reference Prices” No. 1423 dated 29 December 2016.¹⁴

In general, the medicines are traded at free-market prices. Nevertheless, the state price regulation in form of marginal wholesale prices is introduced for medicinal products procured and/or reimbursed for the budgetary funds.

Moreover, the CMU Resolution “On Measures to Stabilise the Prices for Medicinal Products and Medical Devices” establishes marginal sales mark-ups for:

• medicinal products (except for narcotic drugs, psychotropic drugs, precursors and medical gases, as well as drugs to be purchased under controlled access agreements), which are included on the national list of essential medicinal products (such list is available at https://zakon.rada.gov.ua/laws/show/333-2009-%D0%BF#n15);
• medicinal products (except for narcotic drugs, psychotropic drugs, precursors and medical gases, as well as drugs to be purchased under controlled access agreements) purchased wholly or partly for budgetary funds;
• medicinal products (except for insulin drugs), which are reimbursed according to legislature;
• insulin drugs, which are reimbursed according to legislation.

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

Ukrainian legislation does not envisage a specific reimbursement policy for biosimilar medicine and original Biologics drugs. Therefore, such medicines are covered by the general reimbursement procedure.

In Ukraine, the reimbursement mechanism covers cardiovascular diseases, particularly primary and secondary prevention of heart attacks and strokes, type II diabetes and bronchial asthma. The reimbursement is also envisaged for insulin.

According to the CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products under the Program of State Guarantees of Medical Care of the Population”, the reimbursement is conducted for the medicines registered in Ukraine and included in the Register of medicinal products reimbursable under the program of medical guarantees (the “Register “). The Register is approved by the Order of the Ministry of Health and is updated bi-annually (in August and February).

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

Ukrainian legislation does not provide any impact of biosimilar competition on the reimbursement policy of the originator reference products. Medicine is included in the Register independently from others based on the submitted application.

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?

The general procedure of medicines prescribing and dispensing is applicable to biosimilar medicines and original Biologics drugs. Legal framework for prescribing and dispensing comprises:

• The Law of Ukraine “Fundamentals of the Legislation of Ukraine on Healthcare” ¹⁵  (the “Legislature on healthcare”), establishing general grounds for medicines prescribing and dispensing;
• The Law on Medicinal Products, Chapter IV, regulating the medicines sales;
• The Rules for prescribing medicines and medical devices,¹⁶ regulating both general prescribing procedure and prescribing procedure for certain categories of citizens (the “Rules for prescribing medicines”);
• The Procedure for dispensing medicines and medical devices from pharmacies and their structural units.¹⁷

According to the Rules for prescribing medicines, prescription medicines can be prescribed to patients only by physicians of business entities practicing medicine according to medical specialties under the obtained licenses and in accordance with medical posts.

As to dispensing, it is conducted by the pharmacies, their structural subdivisions and pharmacy warehouses (bases) holding respective licenses.

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

The legislation does not address physician-led switching. Nevertheless, Ukrainian physicians are guided by the clinical protocols approved by the Ministry of Health. Such protocols may expressly prohibit switching between the original biological medicines and biosimilar medicines in cases where such switching is dangerous. In other cases, the clinical protocols allow the prescription of biosimilar medicines.

In practice, physicians can prescribe biosimilar medicines in cases where it is not prohibited by clinical protocols. However, such prescription must be made with the consent of a patient according to the general rule of Art.43 of the Legislature on healthcare.

As to the pharmacy-level substitution, this issue is not regulated by the Ukrainian legislation as well. Art. 781 of the Legislature on healthcare obliges pharmaceutical professionals to inform customers at their request about the available medicines with the same active substance. However, due to the biosimilars complexity, they may contain an active substance different from the original biological medicine and, thus, will not be covered by the above requirement.

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?

Ukrainian legislation does not prescribe any specialised post-authorisation procedure for original biological drugs and for biosimilar drugs. Both types of drugs are covered by the general procedures.

In general, the pharmacovigilance system in Ukraine involves both manufacturers of medicinal products (applicants) and regulatory authorities. The Order of the Ministry of Health “On Approval of Procedure for pharmacovigilance” No. 898 dated 27 December 2006,¹⁸requires applicants to appoint a person responsible for pharmacovigilance matters and establishes the following post-authorisation procedures:

• reporting on all recorded and proven cases of serious and non-serious adverse reactions to medicines;
• submitting a periodic safety report regarding the medicines 
• conducting the post-authorisation studies on either voluntary or mandatory basis if risk management plan envisages such studies;
• submitting the updated risk management plan if such update took place due to the available new information.

Moreover, the Procedure for State Registration of Medicinal Products requires the entity to inform the Ministry of Health on any facts requiring updating registration materials.

The applicant must submit the above information to the State Expert Centre of the Ministry of Health (the “Centre”), which is the state enterprise authorised to conduct pharmacovigilance.

The Centre is responsible for:

• analysis of the available information on adverse effects, lack of efficiency etc;
• audit of the pharmacovigilance system of applicants;
• analysis of periodic safety reports, risk management plans.

Based on such analysis, the Centre may propose the Ministry of Health prohibit in full or temporarily or restrict the use of the medicine.

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 in terms of medicines labelling in the event of second medical use patents is provided in Ukrainian legislation. All requirements regarding labelling are laid down in Art. 12 of the Law on Medicinal Products.

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)

No, there have been no significant legal/judicial developments in relation to biosimilars in Ukraine.

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?

There are no draft laws addressing the procurement or significantly changing the legal regulation of biosimilars.

Nevertheless, the Draft Law “On Medicinal Products” No. 5547,¹⁹ registered on 21 May 2021, with the Parliament of Ukraine, defines in detail the notion of “biological medicinal product”, which is not introduced by the implemented laws.

Since the given Draft Law has only been taken as a basis as and is to be considered at the second reading, it is hard to predict when it will be adopted and enter into force.

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1.  The Order of the Ministry “On Approval of the Procedure to Examining Registration Materials for Medicinal Products Submitted for State Registration (Re-registration) and also to Examining Materials on Amendments to Registration Materials during the Validity of the Registration Certificate “ No. 426 dated 26 August 2005, available at: https://zakon.rada.gov.ua/laws/show/z1069-05#n4645
2.  The Guidelines “Medical products. Similar biological medicinal products containing biotechnology-derived proteins as active substance” available at: https://zakon.rada.gov.ua/rada/show/v0582282-13#n425
3.  The Law of Ukraine “On the Protection of Rights to Inventions and Utility Models” No. 3687-XII dated 15 December 1993, available at: https://zakon.rada.gov.ua/laws/show/3687-12#Text 
4.  The Law of Ukraine “On Medicinal Products” No. 123/96-VR dated 4 April 1996, available at: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text 
5.  The CMU Resolution “On Approval of the Procedure of State Registration (Re-registration) of Medicinal Products and Fees for Their State Registration (Re-registration)” No. 376 dated 26 May 2005, available at: https://zakon.rada.gov.ua/laws/show/376-2005-%D0%BF/ 
6.  The Law of Ukraine “On Prices and Pricing” No. 5007-VI dated 21 June 2012, available at: https://zakon.rada.gov.ua/laws/show/5007-17#Text 
7.  The CMU Resolution “On Measures to Stabilise the Prices for Medicinal Products and Medical Devices” No. 955 dated 17 October 2008, available at: https://zakon.rada.gov.ua/laws/show/955-2008-%D0%BF#Text 
8.  The CMU Resolution “On Certain Issues of State Regulation of Prices for Medicines and Medical Devices” No. 333 dated 25 March 2009, available at: https://zakon.rada.gov.ua/laws/show/333-2009-%D0%BF#Text 
9.  The CMU Resolution “The Issues of Declaration of the Change of the Wholesale Prices for the Medicinal Products” No. 240 dated 2 July 2014, available at: https://zakon.rada.gov.ua/laws/show/240-2014-%D0%BF#Text 
10.  The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products under the Program of State Guarantees of Medical Care of the Population” No.854 dated 28 July 2021, available at: https://zakon.rada.gov.ua/laws/show/854-2021-%D0%BF#Text 
11.  The CMU Resolution “On Governmental Regulation of Prices for Medicinal Products” No. 862 dated 9 November 2016, available at: https://zakon.rada.gov.ua/laws/show/862-2016-%D0%BF#Text 
12.  The CMU Resolution “On Certain Issues of Reimbursement of Medicinal Products” No. 135 dated 27 February 2019, available at: https://zakon.rada.gov.ua/laws/show/135-2019-%D0%BF#Text 
13.  The Order of the Ministry of Health “On Adoption of the Rules on the Register of Wholesale Prices for Medicinal Products and Medical Devices, the Rules of its Change and the Forms of Declaration of the Change of the Wholesale Prices for Medicinal Products and Medical Devices” No. 574 dated 18 August 2014, available at: https://zakon.rada.gov.ua/laws/show/z1097-14#Text 
14.  The Order of the Ministry of Health “On Adoption of the Rules of Calculation of Marginal Wholesale Prices for Medicinal Products Based on the Reference Prices” No. 1423 dated 29 December 2016, available at: https://zakon.rada.gov.ua/laws/show/z0012-17#Text 
15.  The Law of Ukraine “Fundamentals of the Legislation of Ukraine on Healthcare”, available at: https://zakon.rada.gov.ua/laws/show/2801-12#n348 
16.  The Rules for prescribing medicines and medical devices, available at: https://zakon.rada.gov.ua/laws/show/z0782-05#n37 
17.  The Procedure for dispensing medicines and medicine devices from pharmacies and their structural units, available at: https://zakon.rada.gov.ua/laws/show/z0783-05#Text 
18.  The Order of the Ministry of Health “On Approval of Procedure for Pharmacovigilance” No. 898 dated 27 December 2006, available at: https://zakon.rada.gov.ua/laws/show/z0073-07#Text 
19.   The Draft Law “On Medicinal Products “ No. 5547 dated 21 May 2021, available at: http://w1.c1.rada.gov.ua/pls/zweb2/webproc4_1?pf3511=72012