European Medicines Agency Guideline on similar biological medicinal products containing monoclonal antibodies (MAbs)
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INNOVATOR PRODUCT: originally developed and approved biologic having established manufacturing reproducibility, patient safety and efficacy, and marketability directed at one or more medical indications.

BIOSIMILARS / FOLLOW-ON PROTEIN PRODUCTS (FOPPs): subsequent versions of biologics that are independently developed and approved after a innovator has developed the original version.

BIOBETTER: products that may be structurally related to and directed at similar indications of an innovator product, but differ positively by one or more characteristics, efficacy/safety or a combination.

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BIOSIMILAR SOURCE brings decades of protein and antibody production experience to the development of your biosimilar or biobetter.

We are your biosimilar source for...

MARKET RESEARCH	DNA SEQUENCE	CELL LINE DEVELOPMENT
PROCESS DEVELOPMENT	CMC PROJECT SUPPORT AND DOCUMENTATION	BIOLOGIC API

Our team has over 100 years of combined experience in the development of marketed biologics. Our experiences in biotechnology began as early as 1980 and several of us were key to early drug development at Genentech, demonstrated by over 30 years of cumulative time at this pioneering company. Team members have played major roles in the development of seven marketed products with a cumulative market value in excess of $20 billion. The protein products and drug candidates the team has worked with encompass a variety of classes of proteins such as: growth factors, cytokines, proteins in the clotting cascade, neurotrophic factors, fusion proteins and monoclonal antibodies.