8^th Asian Biologics and Biosimilars Congress August 10-12, 2017 Beijing, China

Biography:

Beat Flühmann is a Pharmacist, completed MBA and PhD in Molecular Biology. Presently, he is the Director of Vifor Pharma and Steering Committee Member of the Non-Biological Complex Drugs Working Group hosted at Lygature (a non for profit organization). Previously, he had worked for Hoffman La Roche R&D in the area of diabetes and lipid metabolism. His current interest is in regulatory science aspects of nanomedicines.

Abstract:

Showing therapeutic equivalence of nanomedicine follow on products to a reference drug is like for biosimilars more challenging than for low molecular weight drugs. The pharmacokinetics and especially the bio-distribution can be among other parameters which depend on the size/size distribution and composition of the nanoparticle, having implications on the efficacy and safety of the drug. Today, the interaction of these nanoparticles with the body is not fully understood and the clinically meaningful physicochemical parameters are only partially identified. In two clinical studies of chronic kidney disease patients depending on hemodialysis, a lack of therapeutic equivalence was demonstrated for the first time for a nanomedicine, namely Venofer® (iron sucrose), a nano particulate iron preparation for i.v use and it follows on products or better called iron sucrose similars (ISS)-approved on a generic pathway in Europe. Upon switching from the originator iron sucrose to the ISS, a rapid drop in Hb level and iron parameters was observed and higher doses of i.v iron as well as ESA was required to stabilize the patient’s Hb levels. Further clinical reports also showed different safety outcomes such as increased levels of inflammation markers in hemodialysis patients and a significantly higher number of adverse events in gynecology patients. The generic paradigm, lacks the clinical and non-clinical safety and efficacy requirements, is therefore not appropriate to assess nanomedicine follow-ons. Although ISS share the international nonproprietary name with the originator, they can exhibit clinically meaningful differences. Alarmed by these findings, the FDA and EMA have issued draft guidelines and reflection papers that propose a multi-step in vitro, non-clinical and clinical testing to evaluate the extent of similarity as a pre-requisite to define the therapeutic position and the interchangeability or switchability of such nanomedicines.

Biography:

Darius Panaligan is currently the Vice President and Global Head of Commercial for Merck Biosimilars. In addition to developing commercial and go-to-market strategy, he has been focusing on organizational readiness for Biosimilars within Merck. Prior to this he was with Novartis Group for 15 years in multiple global and country roles in both pharma and generics division including 3 years with Sandoz Biopharmaceuticals Global HQ. One of his key projects at Sandoz is the launch of the first biosimilar in the US (Zarxio) and Lead for global G-CSF biosimilar portfolio. His earlier roles within Novartis include Business Head, Marketing, BD&L and Development in both Specialty and Primary Care. He holds a Bachelor of Science and an MBA from the University of British Columbia and Simon Fraser University in Canada, where he also worked in research for a biotechnology start up early in his professional career.

Abstract:

The biosimilar market holds significant potential and benefit for all stakeholders. The experience with first wave of Biosimilar launches provide interesting and in some cases exciting references for the next wave of more complex biosimilars. What does experience in Europe and US could show us so far about the evolving opportunity in Biosimilars? In this talk the challenges and opportunities with commercialization of biosimilars will also be covered.

Biography:

Abstract:

As biosimilar regulatory environment evolve, there is a trend for a convergence on regulatory expectations. This trend is driven by economic forces and is forcing companies that have local quality systems and local regulatory practices to change very rapidly. This trend is affecting how R&D is conducted, how clones and cell lines are acquired, the building of talent and the leveraging of external expertise and resources. The regulatory convergence is creating an internal dynamic that is introducing the need to have one quality system from R&D through commercialization. Biosciences Founder Robert Salcedo will explain how this trends are affecting the ways company are evolving.

Biography:

Ulloa L is a Professor of Surgery at New Jersey Medical School at Rutgers, The State University of New Jersey, USA. He has completed his Post-doctoral training at the Memorial Sloan Kettering Cancer Center, New York. He is an expert in neuro-immune modulation and its translational research for treating infectious and inflammatory disorders such as in sepsis. He has published more than 76 articles in prestigious peer-review journals and is currently serving as an Editorial Board Member of reputed journals.

Abstract:

Polymicrobial sepsis is a leading cause of death in the ICU characterized by detrimental systemic inflammatory response leading to multiple organ failure. We reported that electrical vagal stimulation controls systemic inflammation and prevents multiple organ failure in severe sepsis. We recently reported that transdermal neuronal stimulation attenuates the innate immune response to bacterial infection and prevents multiple organ failure during experimental sepsis. These effects were mediated by the induction of dopamine from the adrenal medulla. However, recent studies indicate that most of the septic patients have adrenal insufficiency and neuronal stimulation failed to control inflammation in adrenolectomized animals. Thus, transdermal neuronal stimulation will fail to induce dopamine and to control inflammation in these patients. Our pharmacological studies indicated that dopamine controls inflammation and improves survival in experimental sepsis by activating dopaminergic receptors type-1 (DR1). DR1-agonists such Fenoldopam was more efficient than Dopamine at inhibiting LPS-induced TNF production in macrophages and also inhibiting serum TNF levels in experimental endotoxemia. In vivo, DR1-agonists inhibit the production of inflammatory factors including TNF, IL1, IL6 and INF-γ even in adrenolectomized animals that mimic adrenal insufficiency in septic patients. These results indicate that pharmacological translation of neuromodulation can provide new insights for treating sepsis.

Biography:

Gustavo H Marin is the Head Professor in Pharmacology Department of National University of La Plata. He belongs to CONICET research system. He is a Doctorate in Medicine, Master in Public Health, Master in Health Economics and in Political Science. He was a Former Medical Doctor in Public Health Assistance of Paris and Post-Doctoral Foreigner Assistant in University Paris, Diderot, France. He is the main author of more than 150 papers and was the Director of Science Policies of Buenos Aires State in Argentina and Director in health care Ministry of Health. Also, he is the Specialist in Hematology and in Public Management. 

Abstract:

Biosimilars are medicines that are not original products subject to patents; greatly reduce the cost of treatments. However, if they are subject to the processes of guarantee of efficacy and safety that are requested to the original biotechnological medicines, the costs remarkably increase. This point force countries to face a dilemma, provide access to their population to innovative treatments or avoid the potential adverse effects associated with their use. Biosimilars are increasingly attractive niche to several countries around the world. They are drugs of biotechnological origin, which has proven to be comparable to the innovative drug of reference once its patent has expired, since they are considered therapeutic equivalents in terms of safety and efficacy. However, these data come from very expensive studies such as randomized clinical trials. It is thus that underdeveloped countries like those of Latin America are in a permanent dilemma of either guaranteeing the access to these new products (generally for catastrophic diseases) or taking care of the population of its potential adverse effects. Latin American governments developed different strategies to face biosimilars market. Abbreviated regulatory pathways, alliance between public and private sector, promotion of science agencies benefits to finance part of local industry to develop new biosimilars and transfer of human resources from the academic to the business are some of those strategies. Brazil, Cuba and Argentina are interesting examples to study because their way chose to develop the industry. While Brazil and Cuba has led policies to increase the development of biosimilar drugs based on local public manufacturing capabilities and on relaxed standards regulation and became one of the majors world producers; in Argentina, exists three majors biotechnology private pharmaceutical enterprises that managed the market, articulating with local science and technology infrastructure and receiving governments’ benefits in order to enter into the biosimilars segment. In this last country the Regulatory Administration (ANMAT) did not accompany the promoting policies relaxing the regulatory standards. Through these experiences, it would seem that in order to be successful in the development of the local biosimilars market, it would be necessary to accompany the market’s efforts with flexibilities in regulatory, registration and production standards.