Emergence of the Biosimilar Sector and Opportunities of Developing Country Suppliers

As biologic products begin to come off-patent, a market is emerging for biosimilars (also known as biogenerics or follow-on biologics). Firms from emerging countries such as India and China have dominated the production of active ingredients in pharmaceutical industries all over the world and are now developing capabilities in biosimilar production. This emergence of a new market dynamic is disruptive to current key players as it has potential challenge their current dominant hold over the market, while for firms from developing countries it creates a sea of opportunities. This rise of biosimilars and capabilities for cheap production in developing country firms has potential to transform patient care in developing countries as well as advanced countries. This paper reviews study data collected at Innogen and the most recent literature to understand how the sector for biosimilars is evolving and the opportunities and challenges faced by emerging suppliers. The aim of the paper is to identify the gaps in the current literature and opportunities for further study in this area

Biosimilar Regulation: Bringing the United States Up To Speed with Other Markets

In light of the expected end of patent terms for many large molecule drugs called biologics, there has been a rise in the development of biosimilars—non-branded, copycat versions of biologics. Unlike generic drugs, which are non-branded versions of small molecule chemical drugs, biosimilars are not identical to the biologic they reference, since biologics are derived from living organisms and are often injected into the patient, which makes them impossible to replicate perfectly. Despite their complexities, biologics exist to treat important diseases such as AIDS, Alzheimer’s, and cancer. In 2010, the Biologics Price Competition and Innovation Act (Biosimilars Act) was added to the Public Health Service Act (PHS Act), outlining the approval process and regulatory plan for biosimilars. The Food and Drug Administration (FDA) subsequently released six Draft Guidance Documents (Guidance Documents) to clarify some of the provisions in the Biosimilars Act and to define ambiguous terms and phrases. Although biosimilars have been an important treatment option in many countries for over twenty years, none have been approved in the United States. On March 15, 2015, the FDA approved Sandoz’s Zarxio after the FDA’s Oncological Drugs Advisory Committee recommended approval by the agency. However, on May 5, 2015, the Appeals Court for the Federal Circuit granted an injunction preventing Sandoz from selling Zarxio until further arguments are heard. The FDA may be progressing toward a more lenient view on biosimilar approvals; however, the court’s injunction indicates that the United States lags in its exploitation of biosimilars, and revisions to the current law will allow for a robust biosimilars market. Previous scholarship has outlined the barriers to biosimilar acceptance in the United States and acknowledged the potential benefit of higher approval rates. This Note analyzes the Biosimilars Act and the Guidance Documents, and proposes revisions to these documents and to the current structure of the insurance and health care systems in relation to biosimilars. These adaptations will allow the United States to improve access to key medical treatments across the country and catch up with other biosimilar markets

Facing the coronavirus crisis: Opportunities and challenges in developing countries, the Argentina case

The coronavirus crisis has exposed tensions in the global pharmaceutical industry and shortages of the global supply chains within the framework of an unprecedented concentration and centralization of capital, highlighting countries interest in having domestic capabilities to respond to pandemic demands. The breaking down of pharmaceutical production chains, and the collapse of the private led manufacture and distribution system, underlines the need for global scientific cooperation and health sovereignty, requiring scientific internationalization, national technological catching up and industrial policy actions on a national or regional basis. As the pandemic reveals a systemic failures of developed countries innovation systems, the weak coherence between scientific opportunities and manufacturing base in new biotechnology fields opens transitory and small windows of opportunity for developing countries. They can insert as early imitators at a lower cost than big pharma profiting from backwardness advantages. Given the knowledge thresholds achieved by local scientific base in molecular biology, the learning and R&D thresholds achieved by the actual public and private technological capabilities, and the productive experience in bioprocesses and in biosimilars, biotech companies in Argentina have a chance to continue an updated import substitution process and to face the challenges posed by the pandemic. This requires advances in three areas of intervention: i) The strengthening of scientific and technological opportunities in close cooperation with the international scientific community; ii) support for the accelerated generation of learning in manufacturing; and (iii) the strategic role of public procurement in enhancing local production of complex drugs, guiding scientific and technological developments to meet the needs of the public health system, and boosting public production of medicinesIn short, the COVID 19 challenge opens up the possibility (driven by the health crisis), of building strategic high-cost drug development and manufacturing capabilities for the public health system. This requires articulating a deliberate action of international North South and South-South scientific cooperation with existing actions and instruments into "big structuring projects" at a national scale.Fil: Gutman, Graciela Elena. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Saavedra 15. Centro de Estudios Urbanos y Regionales; ArgentinaFil: Lavarello, Pablo Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Saavedra 15. Centro de Estudios Urbanos y Regionales; ArgentinaThe Eu-SPRI 2021 conferenceOsloNoruegaThe European Forum for Studies of Policies for Research and Innovatio

Latecomers’ science-based catch-up in transition: the case of the Korean pharmaceutical industry

This thesis investigates the 25-year transitional process of the Korean pharmaceutical industry from its initial focus on the imitative production of generic drugs to the development of new drugs. The catch-up dynamics of latecomer countries in science-intensive industries, such as the pharmaceutical industry, is an overlooked research topic in existing literature on innovation studies. This thesis provides an in-depth analysis of Korea’s science-intensive catch-up and applies an ‘exploration and exploitation’ framework to a latecomer setting and in a novel institutional and market context of the transitional phase. This thesis argues that the rate of change in the transition from imitating drugs to developing new drugs depends on the institutional and organisational mechanisms that enable a new form of technological learning, termed ‘exploratory learning’. This form of learning is often unfamiliar to firms in latecomer countries, whereas it is necessary for producing innovative drugs. That is, latecomers’ institutional and organisational promotion of exploratory learning is related to a ‘pattern change’ in the previously established institutional and organisational routines associated with imitative learning. The findings show that the rate of industrial transition in this sector was constrained by the problematic operation of S&T policies promoting key characteristics of exploratory learning, such as high-risk long-term learning as well as dense interactions between a diverse number of innovation actors. The findings also illuminate some latecomer firms’ initial difficulties in managing the new mode of technological learning, and in strategically applying that mode of learning to overcome the barriers to moving through the transitional phase towards producing competitive innovation. The thesis also suggests that the nature of drugs as integral products, deeply grounded in science, makes it difficult to effectively promote institutional and organisational transformations in favour of exploratory learning

Globalization of biomanufacturing and implications for Massachusetts

Thesis (Ph. D.)--Massachusetts Institute of Technology, Dept. of Urban Studies and Planning, 2010."February 2010." Cataloged from PDF version of thesis.Includes bibliographical references (p. 203-209).Globalization has brought about a major shift in our understanding of how companies organize themselves and how they compete. The fragmentation of firms in their scope and structure, the vertical disintegration of firms through greater outsourcing, and the rise of global supply and value chains has led to new visions for companies ("metanational companies") and new models of production ("modular production networks") that "break free" from geography. In this global economy, many believe that manufacturing has little future in a high-skilled, high-wage region, given competition from lower cost countries. High-tech regions like Silicon Valley and Boston's Route 128 need to focus on design and innovation, and "let others produce what Americans think up." Proponents of this vision dismiss classic models like product life cycle theory (Vernon 1966), which explain the location of manufacturing through the timing of innovation and the maturity of products. To these critics, this model no longer holds because of the ubiquitous nature of innovation, the growth of advanced markets in emerging economies, and the ability to move manufacturing offshore before a product is even standardized. In this view, it is almost inevitable that manufacturing beyond prototypes cannot survive in high-wage countries like the U.S. This attitude, however, presents a false dichotomy between innovation and manufacturing.(cont.) This thesis argues that in advanced manufacturing industries such as biotech manufacturing, it is precisely innovation that brings this complex manufacturing activity to high-skilled, high-wage, technologically advanced regions of the world. This research examines the geographic evolution of biomanufacturing and finds that product life cycle theory provides an excellent model for understanding the dynamics of the industry, albeit with some twists which add to the richness of the literature. These twists are first, the role that institutions, specifically regulation, play in shaping the product life cycle by providing patents that slow the entry of competition. Second, public policy, specifically competitive international tax policy, has become a new differentiator between countries that are seeking to attract high value-added, high-wage manufacturing through the use of tax incentives. Tax-Advantaged Locations (TALs) have become the new low cost destination for advanced manufacturing despite their high wages and costs. Through interviews with 47 biomanufacturing executives and analysis of the geography of biomanufacturing investments made by 96 companies between 2002 and 2013, I find that technologically advanced regions such as Massachusetts retain the most innovative aspects of the industry, including early stage manufacturing as well as the first stage of commercial manufacturing. Massachusetts has a significant opportunity to retain and grow the industry, though the economic development impact is not in a large number of jobs, but in the building of a "regional system of innovation" based in human capital and companies that can usher in new technologies and emerging industries.by Elisabeth B. Reynolds.Ph.D

Intellectual Capital and Financial Performance of Biotech Companies in the Pharmaceutical Industry

The paper’s aim is to analyse the interdependency between the intellectual capital and the financial performance of biotechnological (biotech) companies in the pharmaceutical industry. The analysis was performed for 24 biotech companies in this branch considered during 2002-2014, based on several indicators available on the Thomson Reuters database. The financial performance was measured through the return on assets (ROA), return on equity (ROE) and the debt-to-equity ratio (DE). In order to capture the intellectual capital, the focus was on a designing a new indicator, proposed by the authors, respectively the efficiency of research and development expenditures (ECD), along with another proxy, previously attested by the literature and reflected through the market to-book ratio (MTB). The research methodology resides on applying the correlation method, robust regression, and structural equations modelling (SEM). The results reveal a significant negative relationship between ROA, ROE and MTB, which contradicts the literature and suggests that, for this particular type of companies, MTB isn’t relevant to express the intellectual capital. MTB was positively correlated with DE. When we used the ECD, the results attested a strongly positive and significant relation with ROA and ROE, and a negative one with DE. Therefore, the applied tests confirm ECD as the most suitable indicator to appreciate the intellectual capital for the biotech companies in the pharmaceutical industr

Problemas económico-financieros del sector farmacéutico y posibles soluciones. Análisis de las empresas más representativas en León = Economic-financial problems of the pharmaceutical sector and possible solutions. Analysis of the most representative companies in León

La pérdida de las patentes en los productos farmacéuticos está permitiendo un crecimiento exponencial de la industria no sólo a nivel mundial, sino también a nivel nacional. Más concretamente, la provincia leonesa goza de gran potencial al situarse entre las 5 que más facturan en España, por lo que resulta de especial interés un análisis económico-financiero que esclarezca la situación de las empresas más relevantes del sector. Así pues, el presente trabajo detalla cómo partiendo de situaciones semejantes y nefastas, las tres sociedades analizadas han tomado caminos diferentes que les han posicionado en disímiles situaciones. Las técnicas de contabilidad creativa, la elusión de la realidad, las decisiones precipitadas, el cinismo y la ambición son algunos de los aspectos prácticos que aquí se reflejan, pero también la prudencia y la complicidad empresarial. Adicionalmente, se evalúa el porqué de sus actos y se prevé su situación en el corto plazo, planteando soluciones que les permitirán optimizar la gestión de sus recursos y resultados