Brazilian Strategy to Create a Local Biotech and CMO Industry

Flavio Valente of EMD Serono joined us for World Biosimilar Congress USA 2016 to discuss ‘ Brazilian strategy to create a local biotech and CMO industry ‘. Download this presentation to understand more about: EMD Serono and its Biosimilars unit Biosimilars opportunity in Brazil Productive Development Partnership (PDPs) Merck – Binovis Partnership Brazilian Biotechnology and CMO Industry and more ! …

Francisco Kuribreña of Landsteiner Scientific's 2015 Presentation

Landsteiner Scientific on Mexican biosimilars

We were excited to have Francisco Kuribreña, Director of New Development at Landsteiner Scientific, share his expertise on institutional experiences in preclinical evaluation of biosimilars in Mexico at last year’s World Biosimilar Congress USA. Download his presentation now > You can now download Francisco’s presentation to find out more about: The emerging Mexican economy Mexico and the pharma business The …

Doug Monroe of Kaiser Permanente's 2015 Presentation

Kaiser Permanente: the impact of biosimilars on private reimbursement

We were excited to have Doug Monroe, Project Manager of Biotechnology, Emerging Technology, and Specialty Pharmacy at Kaiser Permanente, share his expertise on the impact of biosimilars on private reimbursement strategies at the World Biosimilar Congress USA. Download his presentation now > You can now download Doug’s presentation to find out more about: The Kaiser Permanente integrated health care delivery system …

Ira Jacobs of Pfizer's 2015 Presentation

Pfizer shares their expertise on biosimilars on the horizon

Doctor Ira Jacobs is a fellowship trained surgical oncologist who is currently Pfizer’s oncology biosimilars global medical lead. Prior to Pfizer, Doctor Jacobs worked as a medical director in oncology global development at Amgen. He led clinical development programs in breast, lung, prostate, and bone cancers. Prior to transitioning into industry, Dr. Jacobs was a staff surgical oncologist. We were …

Vladimir Hanes of Amgen's 2015 Presentation

Amgen’s meaningful biosimilar development programs

We were excited to have Vladimir Hanes, Medical Director of Oncology/Biosimilars at Amgen, share his expertise on the structure, function, and the science of biosimilarity in designing meaningful biosimilar development programs at last year’s World Biosimilar Congress USA. Download his presentation now > You can now download Vladimir’s presentation to find out more about: FDA & EU definitions of biosimilars …

GaBI online

Tentative FDA approval for chemotherapy generic

Aurobindo Pharma (Aurobindo) has received tentative US Food and Drug Administration (FDA) approval for chemotherapy generic palonosetron. The Indian generics maker received tentative FDA approval for its generic injectable intravenous palonosetron at a dosage of 0.25 mg/5 mL on 4 November 2015. The originator product Aloxi/Onicit/Paloxi (palonosetron) is manufactured by Helsinn Birex Pharmaceuticals and was approved by FDA on 25 …

Download Whitepaper: Functionality of silicone oil-free syringe system

Download whitepaper: Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System Paper Abstract:  The functionality of a newly developed silicone oil-free (SOF) syringe system, of which the plunger stopper is coated by a novel coating technology (i-coating™), was assessed. By scanning electron microscopy observations and other analysis, it was confirmed that the plunger stopper surface was uniformly …

Industry Insights: The World Biosimilar Congress 2015

Who is really impacted by healthcare spend? Is it the pharma companies investing millions in bringing drugs to market? The academics reliant on grants to provide research into new formulas and compounds? The service providers who rely on continued drug development and manufacturing to operate? Not exactly. At the end of the day, it’s the patients and their loved ones …

Ensuring Regulatory Compliance Quality And Safety In Biosimilars Production

Ensuring Regulatory Compliance Quality And Safety In Biosimilars Production

At BioPharma India Convention 2014, Samuel Raj Solomon, PhD., RAC (US & EU) Sr. Manager & Head -Biosimilars Regulatory Sciences, Biocon Ltd. India presented on the topic : Ensuring Regulatory Compliance Quality And Safety In Biosimilars Production. Download the presentation to learn: Central Dogma Of Biosimilars Manufacturing Regulatory Compliance For Biosimilars Manufacturing Systematic Risk And Science Based Approach – CQA Hallmarks Of Pivotal CMC …

Thomson reuters report

Thomson Reuters press-release: World Generic Medicines Congress Europe

The World Generic Medicines Congress Europe organized by Health Network Communications brought together industry stakeholders, decision makers, and experts for two days of presentations and discussions focused on market challenges and portfolio strategy. The industry has seen a collapse of traditional commodity generic models, while a new model is emerging from innovation and consolidation, supported by strategic geographic expansion. The …