by Brian J. Malkin, Ami E. Simunovich, Pharm.D., R.Ph., Howard E. Rosenberg, Ph.D., and Stephanie Roberts

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1 European Drug Law Summary Generic, Hybrid, and Biosimilar Medicinal Products by Brian J. Malkin, Ami E. Simunovich, Pharm.D., R.Ph., Howard E. Rosenberg, Ph.D., and Stephanie Roberts I. Overview of Generic, Hybrid, and Biosimilar Medicinal Products A. Generic Medicinal Product (ANDA Analog) A generic drug product is defined as: [A] medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. In such cases, additional information providing proof of the safety and/or efficacy of the various salts, esters, or derivatives of an authorised active substance must be supplied by the applicant. The various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form. Directive 2001/83/EC, as amended, Art. 10(2) (emphasis added). A generic applicant will not be required to provide the results of pre-clinical tests and clinical trials and may cross refer to the originator s dossier if the medicinal product is a generic of a reference medicinal product that is or has been authorized under a full/self-standing application procedure in the Community for at least eight (8) years. Directive 2001/83/EC, as amended, Art. 10(1). The requirement that the generic and reference products have the same qualitative and quantitative composition extends only to the active substance(s) and not to the other ingredients of the product. However, differences in excipient composition or differences in impurities must not lead to significant differences regarding safety or efficacy. These differences will be evaluated in light of all scientific knowledge at the disposal of the reviewing authority. 1

2 The criterion relating to the same pharmaceutical form contained in the definition of generic medicinal product is evaluated with reference to the standard terms for pharmaceutical dosage forms established by the European Pharmacopoeia ( EP ). 1 A generic product and a reference product may be considered to have the same pharmaceutical form if they have the same form of administration as defined by the EP. Further, various immediate-release oral forms, which include tablets, capsules, oral solutions and suspensions, shall be considered the same pharmaceutical form for the purposes of Article 10 generic medicinal products. Directive 2001/83/EC, as amended, Art. 10(2)(b). B. Hybrid Medicinal Product (505(b)(2) NDA Analog) Hybrid applications, similar to 505(b)(2) NDAs, differ from generic applications in that the results of appropriate pre-clinical tests and clinical trials will be necessary for the following three circumstances: (1) The strict definition of a generic medicinal product is not met; (2) Bioavailability studies cannot be used to demonstrate bioequivalence; and (3) There are changes in the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration of the generic product compared to the reference medicinal product. Directive 2001/83/EC, as amended, Art. 10(3). In such cases, the results of tests and trials must be consistent with the data content standards required in the Annex I to Directive 2003/63/EC, replacing Annex I to Directive 2001/83/EC. These applications will thus rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. C. Similar Biological Medicinal Products (Biosimilar Analog) The revised Community Code on Medicinal Products granted the European Medicines Agency ( EMA ) the authority to approve a new category of similar biological medicinal products, commonly referred to as biosimilars or follow-on bilogics Directive 2001/83/EC, as amended, Art. 10(4). An entity seeking to market a biosimilar product may utilize the EMA s CP. The Code does not provide a specific definition of biosimilars; however, it does make clear that biosimilars are not generics. See Directive 2001/83/EC, as amended, Art. 10(4). As a result, they can not be authorized in accordance with the procedures for generic products. Differences between biosmilars and their reference products relate primarily to differences in raw materials or manufacturing processes, and applicants must include the results of appropriate pre-clinical tests or clinical trials relating to these differences. In addition, supplementary data, as provided by Annex I to Directive 2003/63/EC and related guidelines, must be provided. The 1 See for additional information about the EP. 2

3 results and other data from the reference medicinal product s dossier, however, are not included. Directive 20014/83/EC, as amended, Art. 10(4). II. Approval Procedures A. Generic and Hybrid Medicinal Products Generic and hybrid drug medicinal product applications referencing medicinal products authorized via the Centralized Procedure ( CP ) have automatic access to the CP. Regulation European Commission ( EC ) No. 726/2004, Article 3(3). Before submitting a dossier, an applicant should notify the EMA of its intention to submit an application, preferably 6-18 months in advance and justify why the product should qualify for the eligibility for the CP, citing the relevant specific provision(s) of Regulation (EC) No. 726/2004. Generic and hybrid drug medicinal product applications of medicinal products authorized via the national Mutual Recognition Procedure ( MRP ) or Decentralized Procedure ( DCP ) can, at the request of an applicant, be accepted for consideration under the CP, when the applicant shows that the medicinal product constitutes: (1) a significant therapeutic, scientific, or technical innovation, or (2) the granting of a Community authorization for the medicinal product is in the interest of patients at the Community level. The legal requirements and the procedures for making an application for a marketing authorization are set out in Directive 2001/83/EC, principally amended by Directives 2003/63/EC and 2004/27/EC, and in Regulation (EC) No. 726/2004. For generic applications, the legal bases can be found in Article 6 of Regulation (EC) No. 726/2004 and Article 10 of Directive 2001/83/EC, as amended. Annex I to Directive 2001/83/EC, which was replaced by Annex I in Directive 2003/63/EC, contains the detailed scientific and technical requirements for approval of medicinal products. 1. Abridged Procedure (ANDAs, 505(b)(2) NDAs, and Biosimilars Analog) A generic, hybrid, or biosimilar applicant may rely on an innovator s data for the originally authorized product to establish the safety and efficacy of an essentially similar product, but only after the originator of the reference product data has enjoyed a period of data exclusivity. Data exclusivity is different from market exclusivity (at least ten (10) years). Directive 2001/83/EC, as amended, Art. 10. The data exclusivity regime allows generic companies to use a reference product s data in compiling their own dossiers to obtain their own regulatory approvals after eight (8) years, although the product cannot be marketed until the expiration of ten (10) years from the date of first marketing. The ten (10) year market exclusivity may be extended to eleven (11) years, if during the first eight (8) years of granting the marketing authorization application ( MA ), the MA holder obtains an MA for one or more new therapeutic indications. Directive 2001/83/EC, as amended, Art. 10(1). This is called the abridged procedure, meaning the application does not require full pre-clinical or clinical studies. The authorization for the reference product does not need to be presently in force, but it must not have been withdrawn for reasons of public health. Directive 2001/83/EC, as amended, Art

4 2. Bibliographic Procedure (505(b)(2) NDA or Paper NDA Analog) An applicant may replace the results of pre-clinical and clinical trials with detailed references to published scientific literature (information available in the public domain), if it can be demonstrated that the active substances of a medicinal product have been in well-established, medicinal use within the Community for at least ten (10) years, with recognized efficacy and an acceptable level of safety. Directive 2001/83/EC, as amended, Art. 10a. In this regard, the provisions of Annex I in Directive 2003/63/EC apply. Annex I of Directive 2003/63/EC lays down specific rules for demonstrating a wellestablished medicinal use, with recognized efficacy and an acceptable level of safety. The following criteria should be taken into account: (1) the time over which a substance has been used with regular application in patients; (2) the quantitative aspects of the use of the substance, taking into account the extent to which the substance has been used in practice, the extent of use on a geographical basis and the extent to which the use of the substance has been monitored by pharmacovigilance or other methods; and (3) the degree of scientific interest in the use of the substance (reflected in the published scientific literature) and the coherence of scientific assessments. Therefore, different periods of time may be necessary for establishing well-established use of different substances. In any case, the period of time required for establishing a wellestablished, medicinal use of a constituent of a medicinal product must not be less than ten (10) years from the first systematic and documented use of that substance as a medicinal product in the Community. Evidence must be supplied to demonstrate that a constituent has been extensively used for the ten-(10-) year period, but proof of medicinal use may be submitted even in the absence of a marketing authorization. Accordingly, while data demonstrating less extensive use (e.g., use in clinical trials, compassionate use, or named patient supply) may be submitted, this cannot replace the need to demonstrate extensive use for the ten-(10-) year period. Where relevant, the prevalence of the condition or disease should be taken into account when demonstrating such extensive use. Well-established use refers to the use for a specific therapeutic use. If well-known substances are used for entirely new therapeutic indications, it is not possible to solely refer to a well-established use, and an applicant should provide additional data on the new therapeutic indication together with appropriate pre-clinical and human safety data. Here, Article 8(3) of Directive 2001/83/EC, as amended, is the legal basis for the marketing authorization application. A regulatory authority should take into account extensive medicinal use that has taken place in the territory of a new Member State, even if it has partly or fully occurred before the accession of that State. Directive 2001/83/EC, as amended, Art. 10a. B. Similar Biological Medicinal Product (Biosimilars) Following introduction of biosimilars, the EMA, in late 2004 and early 2005, issued guidelines concerning authorization for marketing of biosimilar medicinal products. These include a general guideline document, guidelines concerning clinical and non-clinical issues relating to the comparability of biotechnology-derived proteins as active substance, guidelines concerning quality issues relating to the comparability of biotechnology-derived proteins as 4

5 active substances, and product-specific guidelines. These guidelines reflect the view expressed in the Code that, due to the complexity of biological/biotechnology-derived products, traditional generic approvals would be scientifically inappropriate for these products. Instead, the similar biological medicinal products approach, based on comparability, must be followed. An MA of biosimilar products is granted by the Commission according to the CP. Prior to any Commission decision concerning an MA, including biosimilars, according to the CP, the Committee for Medicinal Products for Human Use ( CHMP ) of the EMA must give its opinion on the application for authorization. The CHMP opinion relates essentially to whether the data and information accompanying the application are sufficient for the type of authorization sought. Although the opinion of the CHMP is not legally binding, the Commission is required by law to provide a detailed explanation if it decides not follow a CHMP opinion. The Commission s decision normally follows two to three months after a CHMP opinion. Traditional generics are evaluated under the bioequivalence standard, but due to the characterization problems unique to biologics, the EMA established a biosimilars approach, elaborated in guidelines, to a biosimilar approval based on comparability principles. See, e.g., Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (June 1, 2006) ( Biosimilar Quality Issues ) at 4; Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues (June 1, 2006) ( Biosimilar Non-Clinical and Clinical Issues ). Under this regime, the applicant must demonstrate that there are no meaningful differences in safety or efficacy between the biosimilar and the reference innovator biologic. The applicant must comply with product-specific guidelines that are issued by EMA through extensive consultation procedures. Generally, extensive comparability exercises are required to establish the quality, safety, and efficacy of the product itself, and the applicant must demonstrate the consistency and robustness of the manufacturing process. Biosimilar Quality Issues at 3-4. The applicant must also demonstrate comparable immunogenicity, which often requires preclinical testing and clinical trials. Id. The EU s approach accepts that differences will persist between biologics products from different manufacturers, and provides the EMA with flexibility to determine the extent and nature of testing required to establish biosimilarity. Approval for each proposed biosimilar is a case-by-case analysis, and the amount of data required depends on the state of the art of analytical procedures, the manufacturing processes employed, as well as clinical and regulatory experiences. Guideline on Similar Biological Medicinal Products ( Biosimilar Guideline ) (Oct. 30, 2005) at 4. In January 2006, the CHMP announced its first positive opinion on an application for authorization of a biosimilar. On April 12, 2006, the Commission granted a centralized European MA for the product Omnitrope (somatropin). This was the first authorization of a biosimilar under the new EU legislation. The Omnitrope application referenced data and information contained in the MA file for Pfizer s hgh, Genotropin. Just two weeks after its first biosimilar approval, the Commission adopted a decision approving a second biosimilar for Valtropin (somatropin recombinant). Valtropin is similar to Humatrope (somatropin), the reference medicinal product produced by Eli Lilly and originally authorized in the EU in

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