For example, Abbvies Humira, the bio-originator of adalimumab, has 12 labelled indications, as shown in Table 6. Table S2 in the Supplementary Materials compiles the raw data with more information on each biosimilar. Department of Pharmacy and Pharmacology, University of Bath, Bath BA2 7AY, UK; Received 2020 Nov 17; Accepted 2020 Dec 28. Figure 3 shows the approval trend for both agencies during the period 20152019. Drug, biologic and biosimilar companies, meanwhile, are debating (in comments on FDAs draft guidance on biosimilar labeling) over whether to include a biosimilars interchangeability status on each new product's label. Some growth factors are also produced in the laboratory and used in biological therapy. For the time being, this is a problem specific to the EU market which in December 2020, had eight marketed forms of the five EMA-approved adalimumab biosimilars as shown in Table 6 (note that Kromeya was withdrawn in February 2020). The user fee program was reauthorized in August 2017 and will now extend through 2022 with additional fees. [(accessed on 22 January 2020)]; World Health Organization Similar Biotherapeutic Products. Regulatory Explainer: Everything You Need to Know About Biosimilars Growth in BS approval in two regulatory areas. Small-molecule drugs are usually chemically synthesized with a fixed, known structure having a molecular weight of less than 1000 daltons, and typically between 300 and 700 daltons. At the time of this snapshot, the EMA had received 65 biosimilar marketing authorizations applications (MAAs) including those subsequently granted, withdrawn, or rejected, and the EC (European Commission) had issued a MA (Marketing Authorization) for 55 BS products following a positive opinion by the CHMP (Committee for Medicinal Products for Human Use) of the EMA. The U.S. Regulatory Pathway for Biosimilars The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was signed into law in 2010 as a part of the Patient Protection and Affordable Care Act (ACA). The first adalimumab biosimilars will not be marketed in the US until January 2023, when Amgen will launch Amjevita after reaching a global resolution ending patent litigations with Abbvie [32]. Data taken from [16]. Abbreviated comparability, an approach that requires only pharmacokinetic and pharmacodynamic data for a biosimilar of a reference product that has a sufficiently characterized reference product. Bethesda, MD 20894, Web Policies By 2023, Humira will have enjoyed 20 years of US market exclusivity. The authors are grateful to Gemma Callaway and Beth Faulkner for stimulating group discussions on this project. 8 Definition: Interchangeability Interchangeable or Interchangeability means: the biological product is biosimilar to the reference product; it can be expected to produce the same clinical result . However, a biosimilar, which can be a monoclonal antibody or cell signaling protein, measures 150,000 daltons, contains 20,000 atoms, degrades over time and can generate a significant immune response. Other studies investigated whether the pharmacokinetic profile of the BS could be modified by the administration device used for the SC administration. The revised design increased the sample size and was restricted to male patients, which were randomized and stratified by body weight. Normally, this licensing approach reflects a companys strategy to gain market share. Extrapolation is a scientific and regulatory principle that refers to the approval of a biosimilar for use in an indication held by the reference product but not directly studied in a comparative clinical trial . Dr Joseph Alvarnas Highlights the Current State of the Oncology Biosimilar Market, BioRationality: A Dr Sarfaraz Niazi ColumnFDA Launches Biosimilar Regulatory Science Program, Genentech, Roche Recall Ophthalmology Biobetter Susvimo, WHEN CHOICE ARRIVES: Competition & Consequences. 30. Introduction to Biosimilars for Immune-Mediated Inflammatory Diseases The 70 results were reviewed individually to establish the reference medicine, approval date, and marketing authorization holder for each biosimilar. Writing in a Perspectives article published in the January 2018 issue of Clinical Pharmacology & Therapeutics, Michele K. Dougherty, PhD, and colleagues at the FDA predict the success of the agencys biosimilars program and anticipate that as biosimilar development programs continue to mature, there will be an influx of biosimilar approval applications filed at the agency, and that the FDA and the biopharmaceutical industry will continue to build on the lessons learned from early biosimilar development programs. Recently (March 2020), some of these products were deemed to be Biologic License Applications (BLAs) and have been removed from FDAs Orange Book and added to the FDAs Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations [6,7]. In contrast, the therapeutic equivalents for Lovenox (enoxaparin sodium) were the object of Abbreviated New Drug Applications (ANDA) suggesting they were considered by the FDA as generic rather than biosimilar products. Pfizer accepts no responsibility for the content of linked sites. Elaine Blais, head of the litigation department at Goodwins Boston office, told Focus in January 2016 that biopharma companies have been lobbying state legislatures like crazy to make automatic substitution difficult. Robust analytical testing, including comparative structural and functional characterization, to establish high similarity of the biosimilar and the reference product, Nonclinical testing to evaluate the toxicity and safety profiles of the biosimilar, In certain cases, additional comparative clinical studies may be warranted to help ensure that there are no clinically meaningful differences between the products. It is not surprising that a company tries to maintain the highest share in the US market by designing a complex net of exclusivity periods and patents to protect Humira. A 2019 IQVIA (Durham, NC, USA) report produced at the request of the European Commission has summarized the impact of biosimilar competition in European markets [2]. The corresponding EMA public assessment reports were scrutinized to gather the details of the clinical studies conducted during phases I and III of their clinical development. Note that Kromeya was withdrawn from the market in February 2020. This site is intended only for U.S. residents. [(accessed on 23 January 2020)]; Pelechas E., Drosos A. Etanercept biosimilar SB-4. U.S. Food and Drug Administration List of Approved NDAs for Biological Products That Were Deemed to Be BLAs on 23 March 2020. EPO has 38 contracting states and provides unified patent prosecution and opposition with the option for national patents by applicant choice after prosecution. This classification that has been object of some debate [24]. In this guide, biologics refers to genetically engineered proteins produced by living cells. In the US, a Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic into interstate commerce. Biosimilars Regulatory Considerations | Pfizer Biosimilars This was done by reviewing the indications of the medicine and classifying the product into one of the following therapeutic areas: inflammatory, oncology, immunology, or hematology. Link to sites outside of Pfizer are provided as a resource to the viewer. Although these restrictions allow market penetration that otherwise would not possible, this plethora of names may lead to confusion among prescribers regarding product choice and avoidance of off-licensing prescribing [23]. This guideline provides scientific advice on designing a study that it is sensitive enough to detect any clinically meaningful differences between the biosimilar and the bio-originator. The agency also says it is considering alternative names for these specific products that would still use a four letter suffix, but where the suffix is based on the product license holder's name, such as "amgn" for Amgen, or "jnsn" for Janssen. PFS, pre-filled syringe; AI, pre-filled auto injector; Data taken from [16]. Intuitively, it would seem that most manufacturers would seek extrapolation to all indications of the reference medicine for their approved BS. ; data curation, I.G. A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU (called 'reference medicine') in terms of structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response). What are Biosimilars and Biologics? | Pfizer Biosimilars Overall, the considerable interest in biosimilar development from the pharmaceutical industry alongside the development of biosimilar regulations worldwide has led to a growing biosimilar market. Concerns about pharmacokinetics, immunogenicity, and toxicity in different patient populations and uses are addressed in this process. And even as more biosimilars come to market and create more competition for costly biologics, the price difference between biosimilars and their reference products (biosimilars in the EU have typically been 15-30% cheaper) may never be as wide as the price difference between generics and their reference products. Explore all of our available resources for more information on the Between 2006 and 2009, the first four years of biosimilar approvals, the EMA approved 13 biosimilars, whilst the FDA approved 16 biosimilars between 2015 and 2018, the US first four years of BS approvals. In terms of major recent developments on the biosimilar legal front, particularly on whether the patent dance is necessary, companies have gone in a couple different directions. Biosimilar medicines: Overview | European Medicines Agency A biosimilar medicine (also sometimes known as a "follow-on biologic," "subsequent-entry biologic" or "follow-on protein product") is a medicine that is similar to another, already-authorized biologic medicine (including vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues and recombinant therapeutic proteins). In part, this appears to be because it enables a biosimilar manufacturer to challenge a RBPs key patents in a single forum rather than multiple nation state patent courts. The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the USs latest Biosimilar Action Plan. Phase III clinical trials conducted for adalimumab biosimilars; data taken from [16]. Comparison of US and European biosimilar regulatory pathways. The information provided in this website is intended only for healthcare professionals in the United States. They have demonstrated similarity to innovator biologic products in terms of quality, safety, and efficacy. Before Biosimilars in the MENA Region: Regulatory Landscape - Biomapas This sponsor carried out two different phase III trials (Table 5), one in each of the above-mentioned conditions. National Library of Medicine Meanwhile, the US Court of Appeals for the Federal Circuit in July 2016 affirmed a district courts ruling that a biosimilar applicant must provide a reference product sponsor with 180 days notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of FDA review. The EMA has taken the lead in the regulatory approval framework for biosimilar products, and WHO has published guidelines on the evaluation of biosimilars . The regulatory approval pathway for biosimilar medicines at EU level was first developed in 2005, enabling the European Medicines Agency (EMEA, currently EMA) to approve the first biosimilar, Omnitrope, in 2006 [4]. However, it is noteworthy that the global market for biosimilars is estimated to reach $2 to $3 billion by 2015 and will be concentrated mostly in Europe.10 Thus, the ability to work fervently toward and ultimately achieve regulatory approval of a biosimilar pathway in the U.S. is likely to have a notable impact on the biologics industry. In many states, an interchangeability designation allows for substitution of the biological product without the intervention of a physician. The most sensitive population group must be chosen in order to allow an accurate detection of clinically meaningful differences [26]. [(accessed on 4 January 2020)]; Rathore A.S., Vulto A.G., Stevenson J.G., Shah V.S. All studies presented in Table 4 are similarity studies, carried out in a similar number of healthy male and female adults, involving a single 40 mg subcutaneous (SC) injection. To meet this end, aspects such as patient population, primary endpoints, and study design (equivalence vs. non-inferiority) must be carefully considered by the sponsors. Regulatory Pathway for Registration of Biosimilars in Russia The EMA approved a record of 16 biosimilars in both 2017 and 2018, with fewer approvals in 2019, while the FDA is growing their biosimilar portfolio at a current, steady pace, yet the overall number of approvals is fewer compared to the EMA's. Figure 3. The continuous growth observed reflects the interest of developers in this sector as well as the continuous commitment of the US Government and FDA to supporting a competitive market place through efficient approval of cost-efficient biosimilars. Pharmacokinetics was studied for each molecule and the data on phase I and III clinical trials were gathered. Although the BPCIA established the pathway whereby biosimilars can reach the market in the US, states (heavily influenced by lobbyists from the biopharma industry) have taken the matter of substituting biologics for biosimilars into their own hands. In the case of adalimumab, the best population were patients with either psoriasis or rheumatoid arthritis. Careers. The totality of evidence is used by the FDA when evaluating new biosimilar products. But in circumstances where a biosimilar is not approved for the same indications as its reference product, unlike with generic drugs, FDA notes that it may be necessary to include information in the biosimilar product labeling relating to an indication(s) for which the biosimilar product applicant is not seeking licensure, in order to help ensure safe use (e.g., when safety information in the reference product labeling is related to use of the product and is not specific to a particular approved indication(s) or when information specific to only the biosimilar products indication(s) cannot be easily extracted).. All FDA-approved biological products (also called biologics) undergo a rigorous evaluation. Within 60 days of receiving that list, the biosimilar applicant is required to respond with its positions on infringement and patent validity, as well as with a list of other patents it believes could be asserted against it. The relevant regulatory authority applies stringent criteria in their evaluation of the studies comparing the quality, safety and effectiveness of the two medicines. Objectives: The purpose of this article is to explore the history of biosimilars, regulatory pathways, and barriers to biosimilar approval. Data mined from [16,19]. Data taken from [5,9,10,11]. Because of the continuous evolution of the biosimilar landscape and its expected growth in the next five years, it will be important to continue research in this field to monitor patients access to these innovative treatments and the benefits they bring to patient outcomes and healthcare systems. The first biosimilar was approved for the European market in 2006. Remicade biosimilars now have 53% of EU market share when compared with their reference products, while Enbrel biosimilars see 29% market share and Rituxan (rituximab) biosimilars, which have yet to be approved in the US but are coming, have gained 13% of market share, according to Bernstein biotech analyst Ronny Gal. The absence of a biosimilar product offering prescribers an alternative, more-economic choice, makes Humira very profitable. Accredited Program: 0.5 CPD Credits. The term does not exist in the EU as EMA explains that its evaluations do not include recommendations on whether a biosimilar should be used interchangeably with its reference medicine, and the decisions on switching from one biological medicine to another are referred by EMA to doctors and pharmacists. A substance made by the body that functions to regulate cell division and cell survival. Interestingly, some approvals corresponded to the same molecule; these products are duplicate MAs (see reference [17] for definition of duplicate MA) and therefore, were marketed as different medicinal products. Despite an increasing number of biosimilars being developed by numerous pharmaceutical companies and authorized by regulatory bodies worldwide, the full economic and clinical benefits of these medicines will only be determined once they become more widely available in the market and used in clinical practice. 2022 MJH Life Sciences and Center for Biosimilars. Biosimilar medicines expand the biotherapeutic market and improve patient access. Because of the complexity of biosimilars and the difficulty of manufacturing them, the cost of any given biosimilar is generally higher than the cost of a generic. IQVIA also offers a look at where the first biosimilars will become available first over the next ten years: A number of other cost-related factors for US biosimilar savings were also outlined by CVS in a report (chart below). For the EU which is the trendsetter the experience with biosimilars (which can only be approved after the reference biologic has been on the market for 10 years - two years less than in the US, though in the US, a biosimilar can be filed four years after FDA approval of the reference biologic) has been relatively smooth, with more than 20 biosimilars approved between December 2006 and January 2018: Wegener Granulomatosis, Microscopic Polyangiitis, Rheumatoid Arthritis, Non-Hodgkin Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Psoriatic Arthritis, RheumatoidArthritis, Psoriasis, Arthritis, Psoriatic; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Psoriasis Spondylitis, Ankylosing, Cancer; Hematopoietic Stem Cell Transplantation; Neutropenia, Anemia; Blood Transfusion, Autologous; Cancer; Kidney Failure, Chronic, Dwarfism, Pituitary; Prader-Willi Syndrome; Turner Syndrome. Timeline for the development of World Health Organization (WHO), European Medicines Agency (EMA) and (Food and Drug Administration FDA) legislation and guidance for biosimilars between 2003 and 2019. Health care providers and This search reflected the status of the EMA repository on the 31 December 2019. (A) Yearly EMA biosimilar approvals between 2006 and 2019. Reference product means the single biologic product licensed under section 351(a) of the Public Health Service Act against which a biologic product is evaluated in a 351(k) application. For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments biosimilars to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption. Accordingly, the applicant may provide notice either before or after receiving FDA approval. The authors acknowledge the following limitations of the study: (a) This work represents a snapshot of the biosimilar approval landscape in December 2019 and no updates subsequent to this date were included in the analysis; (b) To the authors knowledge, all relevant information from the FDA and EMA repositories was gathered but the manual data-mining process precludes absolute certainty; (c) This study focused primarily on the patterns of approvals of biosimilars and thus, other crucial factors determining patient access to these medicines were not included [2,21,22,23]; (d) The study focused on biosimilars approved by the EMA centralized procedure and those approved by national competent authorities were not included; (e) Whilst the trends shown are based in the data gathered (available in Supplementary Materials), the authors chose the aspects on which the analysis focused. For example, Biogen and Samsungs Benepali (approved in the EU in January 2016) is biosimilar to Amgens Enbrel, and both use the non-proprietary name of etanercept. The Biosimilars registration pathway in Jordan provides information on the requirements for the Marketing Authorization Application (MAA) of a Biosimilar, including: An Application in eCTD format Module 1: complete, country-specific as per JFDA requirements Module 2: summaries Module 3: full, addition: the comparability quality part 8600 Rockville Pike EMA and FDA biosimilar approvals between 2015 and 2019. On the Regulatory Approval Pathway of Biosimilar Products Biosimilars, like all biologics, are produced through an intricate, multistep process, using living cells. If, within 15 days of beginning the negotiations, the parties do not agree on a list of patents, then each party will exchange lists of patents that each side wants to litigate. Data gathered from [16,18]. The pathways involve vastly different regulatory frameworks. Reliable Supply Chain Maintaining a reliable supply chain a key responsibility held by manufacturers of biologic medicines, including biosimilars. In biosimilar development, analytical studies are undertaken to identify and compare structural and functional characteristics of protein products. In the US, however, FDA has authorized the use of nine biosimilars (and only three have actually come to market): Sandoz's Zarxio (filgrastim-sndz), which is similar to Amgen's Neupogen, competition for Enbrel withErelzi (etanercept-szzs), which has yet to hit the US market and has patent protection through 2029; for Avastin withMvasi (bevacizumab-awwb), which may not come to market in the US until early 2019; for Humira with Amjevita (adalimumab-atto) and Cyltezo (adalimumab-adbm)and for Herceptin withOgivri (trastuzumab-dkst), whichwas approved in December 2017, though the launch date remains unknown. 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