Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of antibody-based COVID-19 compounds.
What are Biosimilars?
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of more than USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. While the global market for biosimilars is currently more than USD 5.0 billion, industry experts expect this figure to grow up to USD 30 billion by the year 2025.
Anapharm Bioanalytics is a customer-focused bioanalytical CRO specialized in small and large molecule bioanalysis. Led by a team with over 30 years’ experience in method development, validation and sample analysis, we support drug development programs for the pharmaceutical, biotechnological and generic industries worldwide.
Equipped with state-of-the-art LC-MS/MS and LBA technology platforms, Anapharm Bioanalytics provides an array of services including PK studies, biomarker testing and immunogenicity assays throughout preclinical and clinical stages. Our global network of partners allows us to provide full-service outsourcing solutions to conduct preclinical, Phase I-IV clinical trials, and bioequivalence studies for international registration.
Our clients benefit from a deep scientific expertise combined with a robust quality system. All our activities are compliant with GLP and GCP, having undergone 20 regulatory inspections by the FDA, several EU Health Authorities and ANVISA (Brazil).
Whether your drug candidate is a new chemical entity, a new biologic, a generic or a biosimilar, do not hesitate to contact us at email@example.com.
ANTAEA Group of Companies is one of the largest Regional Clinical Research Organizations (CROs), providing high quality support in Southeast Europe, North Africa, Middle East and the Gulf Area.
The Group provides professional, yet flexible solutions, supporting our Clients to maximize their Research resources, in a cost effective manner. ANTAEA is dedicated to Services of scientific quality, management expertise, precision and reliable technology.
The Group includes integrated, marketing consultation services in our portfolio, based on Market Research, which cover products throughout their life cycle.
Specialities: Feasibility Projects, Initial Submissions, Amendments and Notifications to ECs (local and central) and Regulatory Authorities, Clinical Trials Monitoring in several different phases, Contracts for Clinical Trials Management, Contracts for Clinical Trial Rescue Projects, Design and Development of Clinical Trials Projects, Investigator Initiated Projects, Regulatory & Registration Projects (National, MRP, Variations etc.), Statistical Projects, Contracts for Investigator Training, Contract for Regulatory Services Training, Contract for Site Audit
ANTAEA also provides experienced CRAs to the Pharmaceutical and Biotechnology Industries and to CROs, in all the countries where ANTAEA is operating. ANTAEA training on procedures and setting standards and our technical support, guarantee uniformity in quality and timely delivery of projects.
Fountain Medical Development is a clinical contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services in China, US, Japan, and Europe. FMD has extensive global experience in multiple therapeutic areas. The company has completed dozens of registrations trials which supported marketing authorization applications in US and Europe.
Our people is the basis of our success. The 1,700+ professionals are dedicated and diverse. At any given moment, at least 3 languages are spoken in our 20 offices in Asia, US, and Europe.
FMD is on the forefront of the paradigm shift in global clinical development. The regulatory reform in China has the potential to fundamentally change how an innovative therapy is developed. FMD is on the frontline building and shaping the future.
FMD is large enough to serve 7 out the 10 largest Pharma companies, and nimble enough to customize to the needs of startup firms.
In the US and Europe, FMD is doing business as FMD K&L. In China, we operate under the name FMD. Whatever the names are, the company is managed globally by a seasoned senior management team comprised of industry veterans.
FRACTALS is a Network of experts in social research and communication of actual & trends phenomena; it provides advice for strategies and innovations for products, ideas, services, no matter what field, dimension or investiment is involved.
Our approach incorporates several strategies from ethnography, marketing, trend forecasting, and is strongly 2.0 but with the awareness that no automatized platform can ever replace human analysis.