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The paper discusses the entry strategies adopted by research-based firms introducing advanced renewable energy technologies in the electricity production sector, which combines strong incumbent power with fast technological change. Drawing on contributions from the literatures on sustainability transitions and on strategic management of technology we build an analytical framework to address the conditions faced by the new entrants and the attitude of established incumbents towards their technologies. This framework is applied through in-depth case studies of new firms in two energy fields that display different levels of technological maturity: wind and wave energy. The paper presents preliminary results from a first set of case studies, which provide some insights into the "commercialisation environment" prevailing in those fields. They suggest that research-based firms tend to depend on the complementary assets possessed by incumbents, but have conditions to protect their technologies; and that the technology is relevant for (at least some) incumbents, which show interest on them, or are directly involved in their development/use. This is, in most cases, conducive to "cooperation" strategies, which assume different forms according to the stage of development of the technology and its proximity to incumbent competences and business models ; FCT QREN – Operational Programme for Competitiveness Factors, the European Union – European Regional Development Fund and National Funds Portuguese Foundation for Science and Technology under Project FCOMP-01-0124-FEDER-011377, Project PEst-C/EGE/UI4105/2011 and Project Project Pest-OE/EME/UI0252/2011 INESC Coimbra

Biotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the first biosimilar monoclonal antibody to be authorized for use in the European Union. The current document is a position statement of the "Sociedade Portuguesa de Reumatologia" (Portuguese Society of Rheumatology) on the use of biosimilar drugs in rheumatic diseases. Two systematic literature reviews were performed, one concerning clinical trials and the other one concerning international position papers on biosimilars. The results were presented and discussed in a national meeting and a final position document was discussed, written and approved by Portuguese rheumatologists. Briefly, this position statement is contrary to automatic substitution of the originator by the biosimilar, defends either a different INN or the prescription by brand name, supports that switching between biosimilars and the originator molecule should be done after at least 6 months of treatment and based on the attending physician decision and after adequate patient information, recommends the registration of all biosimilar treated patients in Reuma.pt for efficacy, safety and immunogenicity surveillance, following the strategy already ongoing for originators, and opposes to extrapolation of indications approved to the originator to completely different diseases and/or age groups without adequate pre-clinical, safety or efficacy data. ; info:eu-repo/semantics/publishedVersion