Biosimilars and Biologics
All legal aspects surrounding biosimilars and biologics in the Polish pharma market. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 75.
1. Are biosimilar medicines considered the same as generic medicines in your country?
Under the Pharmaceutical Law, a product is deemed as generic with respect to the reference product if it has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product, and if the bioequivalence has been demonstrated in bioavailability studies. There is no legal definition of biosimilar medicine in Poland.
In terms of the abridged authorisation procedure regulated in Art. 15 of the Pharmaceutical Law, if biological medicinal products that are similar to a reference biological product (so-called “biosimilar”), but cannot meet the definition of ‘generic’ set forth above due to differences in raw materials or in production processes in comparison with the reference product, the applicant may integrate the data of the reference product referred to in its application by providing the results of appropriate pre-clinical tests or clinical trials. This is not required for generics in the abridged authorisation procedure.
2. Are all biologic medicines, including biosimilar medicines, patentable in your country?
Yes, biologic medicines and biosimilar medicines are regarded as innovations (inventions) in the field of biotechnology, and therefore, patentable, provided that the patentability requirements are met. The main criteria of patentability include novelty, inventiveness and industrial application.
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, there is no specific regulatory framework for the marketing authorisation of biosimilar medicinal products in Poland. General rules apply (see Question 22, Marketing, Manufacturing, Packaging and Labeling Advertising) if one of the national procedures are to be applied.
Under Regulation (EC) No. 726 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (“Regulation No 726”), generally, biosimilars are eligible for the centralised procedure and for some of them this is the mandatory authorisation procedure.
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?
Generally, under Art. 15 of the Pharmaceutical Law, biosimilar drugs may potentially use the abridged authorisation procedure, which does not require presenting all clinical and pre-clinical data (which is required in the case of the original Biologics drug). However, if a biosimilar drug does not meet the definition of ‘generic’ due to differences in raw materials or in production processes in comparison with the reference product, the applicant may integrate the data of the reference product referred to in its application by providing the results of appropriate pre-clinical tests or clinical trials. Please see the answers to Question 6, Regulatory, Pricing and Reimbursement Overview, and Question 1 on Marketing, Manufacturing, Packaging and Labeling Advertising.
5. What are the requirements for the choice of the reference comparator product?
The reference comparator product is relevant in the case of the abridged authorisation procedure, when for a generic product instead of filing all pre-clinical and clinical data, only references to the data of the reference product is made. It is possible if:
- the marketing authorization holder for the reference medicinal product gave its consent to make such references
- the reference medicinal product has been authorised in any member state of the EU for at least eight years.
The product is deemed as generic with respect to the reference product if it has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference product, and if the bioequivalence has been demonstrated in bioavailability studies. If the biosimilar product is not of a generic nature, then references to the pre-clinical and clinical data of the reference product cannot be made without filing documentation in the relevant scope.
When it comes to placing product on the market in the case of a biosimilar, it will be possible after the expiration of the market exclusivity period, which may be 10 or 11 years.
6. Can the comparator product be sourced from another regulatory jurisdiction? If yes, what are the data needed to support this approach?
The reference medicinal product must be authorised in the EU/EEA.
However, in the EMA’s procedural advice for users of the centralised procedure for similar biological medicinal product applications (EMA/940451/2011), the EMA states that it may be possible for an applicant to compare the biosimilar product in certain clinical studies and in in vivo non-clinical studies with a non-EEA authorised comparator, i.e. a non-EEA authorised version of the reference product, which will then need to be authorised by a regulatory authority with similar scientific and regulatory standards as the EMA.
7. How are the prices of biosimilar medicines regulated? Is this any different from the requirements for the original Biologics drug?
Polish legislation does not contain specific provisions on the pricing of biosimilar medicines or the original Biological drug. In general, the pricing of medicinal products is not subject to regulation; unless the product is reimbursed from the state budget.
Article 13 of the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Use, and Medical Devices (the “Reimbursement Act”) distinguishes the way of establishing the official selling price depending on the existence of at least the ‘substitute in the given therapeutic indication’ – although the substitute’s legal definition indicates generics, in practice this term also applies to biosimilars. The basic rule is that the official selling price of medicinal products that have a substitute must not be (a) higher than 75% of the official selling price of the only substitute reimbursed in a given indication, or, (b) higher than the official selling price of the substitute determining the basis of the financial limit for the limit group, or the cheapest substitute, provided that the basis for the financial limit in a given limit group is a medicinal product with another active substance, in the case of a consecutive substitute reimbursed in a given indication.
8. What is the reimbursement policy for biosimilar medicine? Is this any different from the requirements for the original Biologic drug?
9. Does biosimilar competition impact the reimbursement policy of the originator reference products?
A medicinal product with no substitute is reimbursed on the basis of a decision of the Minister of Health, who sets its original selling price. However, if a substitute for such a product is reimbursed, the official selling price of the originator reference product is limited.
The official selling price of the originator reference product must be (1) not higher than 75% of the official selling price of the substitute reimbursed in a given indication, if there is only one substitute, or, (2) not higher than the official selling price of a substitute determining the limit basis or the cheapest substitute if the limit basis in a given limit group is determined by a medication with another active substance, in the case of another substitute reimbursed in the given indication. What is more, the validity period of the reimbursement decision cannot be longer than the market exclusivity period, i.e. the expiry of the exclusivity period is followed by the lowering of the price in a new decision.
This mechanism aims to lower the prices of originator reference products in a situation of biosimilar (or generic) competition.
In addition, the wholesale price of the first substitute reimbursed in a given limit group, i.e. a group of medicinal products covered by a common financing limit, dictates the limit basis in that limit group, which is then used to calculate the financing limit. This in turn can lead to a further price reduction of the originator reference product.
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?
No specific rules apply to the prescription of non-reimbursed biosimilars.
11. Is the system considering physician-led switching and/or pharmacy-level substitution (without involvement of the clinical decision maker)?
In general, physicians can switch the medicinal product used in the therapy, not excluding biosimilars.
Additionally, as for reimbursed medicinal products, pharmacists are obliged to inform customers wanting to purchase a reimbursed medicinal product of the possibility of purchasing a medicinal product other than the one prescribed, which has the same international non-proprietary name (INN), dosage, and pharmaceutical form, does not cause therapeutic differences, has the same therapeutic indication, and whose retail price does not exceed the public financing limit and the retail price of the medicinal product prescribed. The pharmacy is obliged to ensure the availability of such medicinal products. In practice, these criteria may not be applicable to biosimilars due to their nature.
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?
General post-authorisation requirements apply to biosimilar medicines and biologicals (see Question 5, Marketing, Manufacturing, Packaging and Labeling Advertising).
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?
In general, substitutes (generics and biosimilars) for a reference product may be authorised for any indication for which the reference product was authorised, provided its protection period has expired. However, if – for example – one or more of these indications are still protected by patents for a second medical use, the marketer of the substitute may not include such indications, i.e. the novel patented indication, in its SmPC.
Article 11 of the Directive 2001/83/EC describing what information the SmPC should contain introduces a mechanism called “skinny labelling” for generic medicinal products (applicable to biosimilars). Under this mechanism, those parts of the SmPC of the reference medicinal product referring to indications or dosage forms which were still covered by patent protection at the time the generic was marketed need not be included. This aims to facilitate the marketing of substitute medicinal products before all the patents protecting the reference medicinal product have expired.
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)
In 2018, the Patients’ Ombudsman decided that switching a biological drug to a biosimilar drug by a hospital due to financial reasons is not acceptable and violates patients’ rights. In its view, the decision on administrating a particular drug should not be made automatically, but adjusted to an individual patient. This decision was upheld by the Administrative Court in Warsaw and the Supreme Administrative Court.
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 specific proposals for reform with regard to biosimilars. However, the Ministry of Health has been emphasising the promotion of biosimilars as substitutes and the wider reimbursement of biosimilars, significantly reducing the costs of therapy.