Biosimilar Market Research Articles

Current trends for biosimilars in the Latin American market

The number of approved biological medicines in the global pharmaceutical market has increased in recent decades. However, their high costs have also promoted the development of biosimilar medicines, following the expiry of the patent of the reference drug. Biosimilars are approved medicines of biological origin which have no statistically significant differences in terms of quality, safety and therapeutic efficacy in comparison with the reference biological. Drugs marketed as biomimics meanwhile are copies of monoclonal antibodies and fusion proteins that have not demonstrated bioequivalence to their reference biologicals. Across the world, regulations have been developed to ensure the safety and efficacy of biosimilar products, which can reduce public health expenditure and improve patient access to biological medicines. As a result, Latin America has begun to invest in the development of these drugs. The objective of this literature review is to describe the development of the biosimilar and biomimic market in Latin America.

Biosimilar medicines for psoriasis. Positioning of the Mexican Academy of Dermatology.

The development and marketing of biosimilars opens a new scenario in the treatment of many pathologies, including psoriasis. This article reflects the position of the Mexican Academy of Dermatology (AMD) on the use of biosimilar medicines for the treatment of psoriasis in Mexico. In summary, the AMD estates that there is sufficient evidence to accept comparability of pharmacokinetics and pharmacodynamics of some biosimilar medicines to adalimumab, infliximab and etanercept; this evidence does not sufficiently support interchangeability or indication extrapolation. It is essential to establish a close pharmacovigilance not only to guarantee compliance with the Cofepris rules in Mexico, but also to facilitate the effective monitoring of the adverse effects of biosimilar medicines. Although the goal of biotechnological drugs is to achieve substantial savings for patients and public institutions, no economic criteria should prevail over rigorous scientific criteria that guarantee maximum therapeutic efficacy and optimum safety for patients.

Biosimilars in Belgium: a proposal for a more competitive market

ABSTRACT More than ten years after the first biosimilars were authorized for use in the European Union, Belgium still experiences limited competition from biosimilars, as exemplified by low market shares. Achieving high biosimilar market shares is not necessarily a goal in itself, as cost savings are also realized by mandatory price reductions on originator medicines in Belgium. However, we believe that biosimilars play a role in ensuring the long-term sustainability of the off-patent biologicals market. It is therefore crucial to list what has been done and what is needed to support the Belgian government in establishing a policy framework for a competitive off-patent biologicals market. We provide a comprehensive overview of the Belgian biosimilar market, including existing hurdles for biosimilar use in Belgium. Based on these hurdles and supplemented with learnings from other European countries, we propose practical recommendations that can be implemented to overcome them. Several Belgian stakeholders had the opportunity to comment on these recommendations. Specifically, we suggest to evolve towards a long-term consistent, integrated policy framework via i) the creation of a proactive and transparent climate supporting a level playing field for both biosimilar and reference product, including public dissemination of how savings at the level of the Belgian healthcare system are used, ii) investment in educational activities, including raising awareness of societal responsibility, iii) enforcement of the practical implementation of public procurement law, and iv) the development of incentives for physicians, who are key stakeholders in the Belgian off-patent biologicals market.

Funding Innovation Thanks to Anti-TNF-α Biosimilars Uptake: The Economic Impact in Italy

INTRODUCTION: Anti-TNF-α biosimilars (ATB) hold the promise of reducing costs leading in improving access to bio-logical therapies. There is limited insight into how the savings generated by biosimilars may translate into patient benefit in other disease areas.AIMS: To assess the economic savings for Italian National Health System (NHS) due to the expansion of ATB market, together with a reduction in their price and to illustrate how this potential savings can be used by NHS to fund orphan drugs.METHODS: Trend of IMS Health monthly sell-in units (August 2016-December 2019) were used to estimate the current biologic and biosimilar market for rheumatic and inflammatory bowel disease in Italy and its evolution up to 2022. The scenario for 2019-2020 was compared with the future evolution (2021-2022) assuming an increasing uptake of biosimilars in the Italian market. Finally, it was estimated how these savings can potentially fund the treatment of orphan drugs, without increasing the Italian NHS budget.RESULTS: Italian biologic and biosimilar market remains stable in the next years (about 4 million units both in the current scenario and in the future evolution market) with a slight decreasing of less than 2%. However, according to our assump-tions, ATB market is expected to increase of about 33% in the next two years, covering 67% of the total Italian market, mostly due to biosimilar etanercept. Total savings due to biosimilars increases from € 96 million in 2019 to € 161 million in 2022 corresponding to a mean annual savings of about € 130 million. Such savings would permit funding 17.4% of the actual orphan drugs market corresponding to 2,600-4,800 new patients.CONCLUSIONS: The introduction of biosimilars in a range of rheumatic, dermatological and inflammatory bowel disease can be an opportunity to increase patient access to innovative treatments. Potential savings due to biosimilars uptake could lead to a re-allocation of economic resources to fund innovative therapies.

Provider differences in biosimilar uptake in the filgrastim market.

To identify differences in biosimilar uptake across providers and to examine the association between provider biosimilar uptake and observable practice-level characteristics. A retrospective analysis of 100% of a commercial medical claims database from June 2015 to June 2018. We focused on providers of biologic (Neupogen) and biosimilar (Zarxio) filgrastim. We compared trends in biosimilar uptake across 2 dimensions: provider's place of service and provider's prescribing exclusivity. We then used multivariate regression analysis to estimate the association between any biosimilar uptake and practice-level characteristics, controlling for geography and time fixed effects. Relative to hospital-based providers, office-based providers were earlier and quicker adopters of the biosimilar filgrastim. Across all places of service, providers predominantly prescribed either the biosimilar or biologic, exclusively, for all their patients. Any biosimilar uptake was more common among providers in office-based settings, providers with larger practice sizes, and providers with a higher share of health maintenance organization patients, nonwhite patients, and younger patients. This study uncovers important associations between provider practice characteristics and biosimilar uptake. Our findings suggest that provider awareness and incentives can be important levers to strengthen US biosimilar market penetration and competition.

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases.

Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars—biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators—can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.Electronic supplementary materialThe online version of this article (10.1007/s40265-020-01256-5) contains supplementary material, which is available to authorized users.

Perspective, perceptions, and promulgation of biosimilars: A questionnaire-based study to assess and understand the current challenges of biosimilars to the potential and intended users.

ABSTRACTIntroduction:Biosimiliar, a copy of reference biological product, is making a buzz across the globe for its upper edge therapeutic usage. According to the market research report published by P&S Intelligence, biosimilars market is expected to generate $26.7 billion revenue by 2024, advancing at a CAGR of 29.6% during the forecast period. The first biosimilar to medicine Omnitrope, was approved in Europe by EMA (European Medicines Agency) in year 2006. Till date countries like US, China, Japan, India and many more have generated regulatory guidelines for biosimilars.Aim:Current study addresses the issues and challenges faced by Industry and regulators with their potential solutions and recommendations.Materials and methods:The questionnaire having 21 important questions/comments was given to participants after explaining the purpose of the study. The response in terms of responders V/s non-responders, agree V/s disagree, yes V/s no was recorded and analyzed by descriptive statistics.Results and Discussion:The study shows the limitation regarding the qualified personnel involved in biosimilars, as approx. 91% people believe that there is lack of expertise in this field. The same can be achieved through government initiatives for bridge courses which is also strongly felt by the major (83.6%) stakeholders participated in the study.

Insight into Biosimilars: Short Description, Analytical Assessment and Market

The World Health Organization (WHO) defines a similar biotherapeutic product, i.e. a biosimilar as a biotherapeutic product that is similar in terms of quality, safety and efficacy to an already licensed reference product on the market (termed as originator or innovator). To ensure similar efficacy and safety, comparability studies for biosimilars should be carried out at quality, preclinical and clinical level.Glycosylation profiles of biosimilars are getting an additional critical quality attribute. The portfolio required for regulatory comparison of identity and release testing has to be assessed with a large number of analytical tests, which are presented here in detail for the example of adalimumab.Adalimumab, as one of the blockbuster drugs and the best-sellingpharmaceutical product world-wide, is analyzed additionally with a competitive field presenting the marketed products or such in development. This competitive field is not surprisingly very crowded. Furthermore, general information about the currently marketed biosimilars includingModeofAction (MoA), clinical indication(s), patent situation, and market situation are shortly summarized for each of the respective originator/biosimilar molecules.As there are not only markets in developed and highly regulated countries, but also in other regions, examples for companies and products in Asia, South and Middle America, and even in Africa are highlighted as well.

The Biosimilar Action Plan: An Effective Mechanism for Balancing Biologic Innovation and Competition in the United States?

The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while simultaneously providing patients with access to affordable and innovative drug treatments. This tension exists whether the drugs at issue are chemically-synthesized or complex large molecule drugs, such as biologics. In 2010, Congress passed the Biologic Price Competition and Innovation Act (BPCIA). The statute created a statutory approval pathway for biological products shown to be biologically similar (biosimilar) to the originator or “brand” biologic, while retaining the same safety, purity, and potency as the brand. Unfortunately, the BPCIA’s provisions failed to accelerate biosimilar product development in the United States and we continue to lag behind Europe in providing patient access to affordable biosimilars. To help stimulate the U.S. biosimilar market, the Food and Drug Administration (FDA) issued the Biosimilar Action Plan (BAP) in July 2018. BAP focuses on four key strategies: 1) streamlining the biosimilar approval and product development process; 2) increasing biosimilar informational resources; 3) maximizing scientific and regulatory clarity; and 4) “getting competitively priced biosimilars into the market by reducing the gaming of FDA requirements and other attempts to unfairly delay competition.” An enhanced informational platform and streamlined approval process should increase the biosimilar approval rate and accelerate biosimilar product development. However, the FDA’s regulatory powers are insufficient to curb the gaming and other anticompetitive behaviors that most negatively impact access, such as: 1) rebating schemes; 2) pay-for-delay agreements; 3) leveraging innovator patent rights to impede biosimilar market entry and 4) other regulatory abuses. Partnerships with key stakeholders, such as Congress, the Federal Trade Commission, States, Non-Governmental Organizations, and Payors are therefore crucial to achieving the BAP’s overarching goal of “promoting competition and affordability [of biosimilars] across the market.” The recently proposed Biologic Patent Transparency Act provides an example of how Congress can work in tandem with the FDA and other stakeholders to foster innovation and build a competitive and sustainable biosimilar marketplace for patients in the U.S.

Biosimilars in Developed Economies: Overview, Status, and Regulatory Considerations

Biotherapeutics dominate the pipelines of pharmaceutical companies across the world today with products ranging from hormones, immune-modulators, monoclonal antibodies (mAbs), blood coagulation factors, enzymes and vaccines. However, they are considerably more expensive than their small molecule counterparts (pharmaceuticals) and as a result their contribution to the already unacceptably high healthcare costs in the developed economies (Europe, United States, Japan, Canada and South Korea) has been in the limelight in the last decade. This has resulted in the rise of biosimilars, seen as the affordable versions of innovator biotherapeutics. As the developed economies form the majority of the global sales of biotherapeutics, they are an attractive market for the biosimilars as well. Regulatory considerations for approval of biosimilars in these jurisdictions is likely to have a major impact on the adoption of biosimilars. In this paper, we offer a perspective on this topic while focusing on the developed markets. This article summarizes the main regulatory requirements for approval of biosimilars in Europe, United States, Japan, Canada, and South Korea. An overview on current biosimilars status and market in the aforesaid countries has also been included.

PMU151 ECONOMIC BURDEN OF BIOSIMILAR DELIVERY IN FRANCE: REAL WORLD ANALYSIS FROM THE PERMANENT SAMPLE OF NATIONAL HEALTH INSURANCE BENEFICIARIES, BETWEEN 2007 TO 2017

Biosimilars drugs represent significant savings for the French National Insurance. The biologic drugs environment is challenging in France and health authorities create stronger incentives to encourage biosimilar prescription and the loss of patents has accelerated. The aim of the study is to analyszed the economic burden and the market share evolution of biosimilar drugs based on claims data “permanent sample of national health insurance” between 2007 (first biosimilar launch) and 2017. Retrospective observational study of biosimilars and reference products consumptions. We have extracted the health insurance reimbursement for all biosimilar and reference medicinal products commercialized in France during the period. Market shares were calculated by dividing the number of biosimilars packages delivered to all drug packages (biosimilar and references). Costs (in Euro) were extrapolated to national level by using coefficient published by the national health insurance office (CNAM). Consumptions of 11 biosimilars and 6 reference drugs were analyzed. Biosimilar expenditures were €0,7 billion compared to €6,5 billion for reference drugs. Biosimilar market shares increased from 4% to 19% between 2010 and 2017. Biosimilar drugs like filgrastim and epoetin had the most important expenditures (respectively €286 million and €186 million). In 2017, these same drugs had the most important market shares with respectively 80% and 63%. On the other side, biosimilar drugs like etanercept and insulin glargin had the smallest expenditures during the period (respectively €7,3 million and €7,2 million) and the smallest market share (4% each) in 2017. This study demonstrate that biosimilar drug market increased during the period. The “Health National Strategy » biosimilar objective for 2022: 80% of market share is achievable if the market keeps the actual trend. Patient’s characteristics description could be complementary to this study, to give more information to the biosimilar landscape.

PBI40 TENDER APPROACHES IN THE OFF-PATENT BIOLOGICAL MEDICINES MARKET: A EUROPEAN COMPARATIVE ANALYSIS

Tendering has become an important strategy to contain spending when purchasing pharmaceuticals. However, tender approaches, such as awarding total market volume to a sole competitor, may threaten the sustainability of the off-patent biological medicines market. This study aims to (i) map the organisation and implementation of tendering across Europe, (ii) investigate tender frameworks and award criteria, (iii) identify best tender practices and (iv) formulate recommendations. First, to gather information on tender implementation and applied frameworks, a quantitative web survey was completed by hospital pharmacists and procurers across Europe. Second, to explore insights and derive learnings, semi-structured interviews were performed with hospital pharmacists, procurers and industry from countries representing different healthcare systems: Norway, Denmark, Italy, UK, France and Belgium. A hundred survey participants representing 26 countries were included for descriptive analysis. Although the implementation and experience with tendering for off-patent biologicals was heterogeneous among participants, similar selection and award criteria were often applied. The majority of participants indicated the use of selection criteria beyond price. Twelve interviews were conducted. Interviewees mentioned the complex trade-off between benefits and risks of national and regional/hospital tendering systems. National systems, representing a larger purchasing capacity, may result in larger discounts, but may also push other competitors out of the market. Regional/hospital systems may be advantageous for long-term competition by providing an opportunity for multiple players, however they may also result in less competitive prices. Some interviewees were apprehensive about the risk of competitors withdrawing from the market due to unexpected high price pressure. Due to variations between regions, national healthcare systems and product classes, it may not be possible to create a ‘one-size-fits-all’ tendering framework. However, overarching best practices towards sustainable tendering for off-patent biologicals were identified, including: (i) multiple winner tenders, (ii) differentiation beyond price and (iii) re-opening of contracts upon biosimilar market entry.

Current perspectives on biosimilars

In this work, an overview of the biosimilars market, pipeline and industry targets is discussed. Biosimilars typically have a shorter timeline for approval (8 years) compared to 12 years for innovator drugs and the development cost can be 10–20% of the innovator drug. The biosimilar pipeline is reviewed as well as the quality management system (QMS) that is needed to generate traceable, trackable data sets. One difference between developing a biosimilar compared to an originator is that a broader analytical foundation is required for biosimilars and advances made in developing analytical similarity to characterize these products are discussed. An example is presented on the decisions and considerations explored in the development of a biosimilar and includes identification of the best process parameters and methods based on cost, time, and titer. Finally factors to consider in the manufacture of a biosimilar and approaches used to achieve the target-directed development of a biosimilar are discussed.

Why Are Biosimilars Not Living up to Their Promise in the US?

Biologics are among the most expensive prescription drugs in the United States, posing significant barriers to patient access to necessary treatments. An abbreviated approval pathway for biosimilars, near-identical versions of biologics made by different manufacturers, was created by Congress in 2010 to stimulate competition in hopes of driving down costs and expanding access. However, as of February 2019, only 17 biosimilars have been approved, with only 7 currently on the market. Of the few biosimilars currently available to patients, overall utilization has been limited. This article examines the current landscape of the biosimilar market, characterizes tactics employed by biologics manufacturers to delay market entry and deter prescribing of biosimilars, and assesses ethical issues related to increasing the adoption of biosimilars.

Challenges in Post-marketing Studies of Biological Drugs in the Era of Biosimilars: A Report of the International Society for Pharmacoepidemiology 2019 Mid-Year Meeting in Rome, Italy.

Several controversial issues related to challenges in the post-marketing studies of biological drugs, including biosimilars, were discussed at the International Society for Pharmacoepidemiology (ISPE) 2019 Mid-Year Meeting in Rome (Italy) in April. In recent years, the marketing of biosimilars has been growing, thus offering opportunities for wider access by patients to high-cost biological drugs as well as ensuring the economic sustainability of national healthcare systems. Through the comparability exercise required for marketing approval, the similarity of biosimilars to the reference products in terms of efficacy, safety and quality has to be demonstrated in pre-marketing studies. In Europe, the 15years of experience of marketing of biosimilars has allowed the accumulation of a significant amount of scientific evidence confirming the comparability of the benefit-risk profile of biosimilars and originators. However, some aspects remain to be addressed both from a scientific and regulatory perspective, such as interchangeability and the automatic substitution of originators and biosimilars. The (long-term) monitoring of all biological drugs, including biosimilars, in real-world settings is warranted, with the ultimate goal of integrating pre- and post-marketing evidence relating to the aforementioned open questions. This conference report describes priorities, data sources and methodological strategies for the post-marketing surveillance of biological drugs in the era of biosimilars.

FDA guidance aims to spur biosimilar availability

In a long-awaited move, the US Food and Drug Administration has released a set of guidelines intended to stoke the market for biosimilars, generic versions of complex biological drugs, frequently p...

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 2-Biosimilar and Originator Etanercept in the Outpatient Setting.

BackgroundDiverging approaches towards market entry and uptake of biosimilars, even within a country, leads to regional variation in biosimilar use. This is the case in Sweden, where the 21 county councils control the healthcare budget and offer regional guidance.ObjectivesThis study aimed to analyse the market dynamics of originator and biosimilar etanercept (outpatient setting) in the different counties of Sweden, and examine the influence of local policy measures and practices, in addition to national policy.MethodsThis study was performed in three steps: (1) a structured review of the literature on (biosimilar) policies in Sweden; (2) analysis of market data on the counties’ originator and biosimilar etanercept uptake (quarter two 2012 to quarter four 2017) provided by IQVIA™; and (3) discussion of findings in face-to-face semi-structured interviews with the national pricing and reimbursement agency, key experts in the county councils of Skåne, Västra Götaland and Stockholm, and an industry representative.ResultsNotwithstanding the existence of a national managed entry agreement for etanercept, wide variations in biosimilar market shares between counties were observed (40–82% in 2017). Over time, early and late adopters of biosimilar etanercept can be distinguished. In quarter four 2017, biosimilar market shares of all counties slightly decreased in accordance with the lower priced originator product from 1 October 2017. As prescriptions for treatment with etanercept are often provided for a year, two approaches are possible to switch patients: active pullback of prescriptions resulting in additional workload, or wait until the patient’s next visit. Qualitative analysis indicated that the choice to use the biosimilar or the originator product depends on differences in rebated prices of the biosimilar and originator product, the presence of key opinion leaders, local guidelines, and financial streams and local gainsharing arrangements. Our estimates of current rebated prices and costs after gainsharing for the county councils and Government reveal only limited price differences between products.ConclusionsRegional variations in use of biosimilar etanercept can be seen although prices are coordinated nationally. This suggests that counties react differently to price differences and highlights the role of local policy and attitudes of stakeholders towards biosimilars and switching. It seems that some counties are hesitant to switch patients, as it is associated with an increased administrative workload that might not be compensated for by savings associated with a lower priced product.

Biosimilars and the Patent Law

Biopharmaceuticals are one of the most important recent medical innovations which revolutionised many areas of medicine. Dynamic development of the market for biopharmaceuticals in recent years is related to the expiration of the IP exclusive rights on original innovative biological medicinal products. This has resulted in introduction to the market of biosimilars. One of the greatest challenges concerning the emergence of biosimilars is modifying the law to ensure balance between the market development of biosimilars and access of patients to biological therapy. The development of biopharmaceutical inventions works hand in hand with the patent system. It should be underlined that IP rights in the biopharmaceutical sector are crucial for promoting innovation due to the very long time of product development. It is exactly the area in which patents make sense to fill the gap between innovation and the risk of imitation. However, the existing patent system is too expensive and slow for biotechnology development. It should be further adapted to the needs of biopharmaceuticals.

Factors Affecting Health Care Provider Knowledge and Acceptance of Biosimilar Medicines: A Systematic Review.

Newly developed biosimilar agents confer significant cost-saving advantages, yielding the potential to mitigate rising drug costs and expand patient access to care for important biologic therapies. Biosimilar market uptake greatly depends on health care provider willingness to promote, prescribe, and use biosimilars in clinical practice. To perform a systematic review evaluating current U.S. and European health care provider knowledge, perceptions, and prescribing behaviors of biosimilar medicines to assess the need for clinician-directed biosimilar education. An electronic literature search was conducted using journal databases, including PubMed, Embase, and Cochrane Library. Terms related to biosimilar agents, survey questionnaires, and education were used. Two independent reviewers evaluated 158 citations published from January 1, 2014, to March 5, 2018 that were the result of this search. Studies in English were included if they surveyed U.S. or European physician and/or pharmacist knowledge, attitudes, and/or prescribing preferences of biosimilar drugs. Overall trends in prescribing behavior and perceptions were abstracted. A total of 20 studies met inclusion criteria. Three studies originated from the United States and 17 were from Europe. Hospital specialists, gastroenterologists, and rheumatologists were the most frequently surveyed practitioners. The percentage of biosimilar prescribing varied widely between countries and within similar practice fields. If used, biosimilars were predominantly prescribed in biologic treatment-naive patients. An overall lack of biosimilar familiarity in U.S. and European health care settings accompanied concerns about biosimilar safety, efficacy, extrapolation, and interchangeability. Detailed descriptions of biosimilar education programs were lacking within the literature. Findings from this review indicate that U.S. and European health care providers still approach biosimilar medicines with caution, citing limited biosimilar knowledge, low prescribing comfort, and safety and efficacy concerns as main deterrents for biosimilar use. To realize the full cost-saving potential of biosimilar medicines, clinician-directed biosimilar education will be imperative to address gaps in biosimilar knowledge, facilitate prescribing changes, and ultimately increase biosimilar use. No outside funding supported this study. The authors have nothing to disclose.

PDA Biosimilars Workshop Report (September 27-28, 2018)-Getting It Right the First Time for Biosimilar Marketing Applications.

This workshop report summarizes the presentations, the breakout session outcomes, and the speaker panel discussions from the PDA Biosimilars Workshop held September 27-28, 2018, in Washington, DC. This format was deliberately selected for the workshop with the expectation of delivering a post-workshop paper on current best practices and existing challenges for sponsors. The event, co-chaired by Dr. Stephan Krause (AstraZeneca Biologics) and Dr. Emanuela Lacana (CDER/FDA), was attended by 140 agency and industry representatives. The workshop was separated into three major sessions P1: Regulatory Perspective, P2: Challenges in Biosimilar Development, and P3: Demonstrating Analytical Similarity. Each of the three sessions started with agency and industry presentations. Participants then split into two concurrent roundtable discussion groups to hear the answers to questions that had been provided to all participants one week prior to the event. The sessions were recorded. This paper provides consolidated answers to specific case studies for current challenges to sponsors and agencies. In addition, the panel discussion notes following each breakout roundtable session, as well as brief talk summaries of all speakers, are provided. The first session explored the challenges encountered with submission of biosimilar marketing applications from the perspectives of regulatory agencies. Expectations for a successful submission of the chemistry, manufacturing, and controls (CMC) information were described. The second session addressed high-level technical challenges and how to avoid pitfalls frequently encountered during biosimilar candidate development, including data quality expectations, creation of the final control strategy, and strategic choices necessary for candidate selection and development. Both regulatory perspectives and industry experience were shared. The last session explored the use of statistical tools to provide meaningful contributions to the demonstration of analytical similarity. The presentations highlighted common issues and practical challenges that arise during the application of statistical tools.LAY ABSTRACT: Significant challenges are still-remaining for sponsors and agencies to successfully develop and license Biosimilars. A Biosimilars Workshop was therefore held on 27-28 September 2018 in Washington, DC, to find practical solutions to the remaining challenges. The workshop planning committee with members from industry and agencies prepared specific case studies focused on some of most difficult situations. The workshop was separated into three major sessions (P1 - Regulatory Perspective; P2 - Challenges in Biosimilar Development; P3 - Demonstrating Analytical Similarity) and each session attempted to provide practical solutions to the relevant case studies. This first session explored the challenges encountered with submission of biosimilar marketing applications from the regulatory agencies' perspectives. Expectations for a successful submission of the CMC information were described. The second session addressed high-level technical challenges frequently encountered during biosimilar candidate development, including data quality expectations, the creation of the final control strategy, and strategic choices necessary for candidate selection and development. The last session explored the use of statistical tools to provide meaningful contributions to the demonstration of analytical similarity and practical challenges that arise during the application of statistical tools.