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Brief Introduction:
Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies of biopharmaceuticals (proteins) that can be made after the patent on the original product has expired Example: Epoetin, G-CSF insulin, somatropin ,
The required capital investment in property, plant, and equipment and the costs of manufacturing will be much higher for biosimilars than for generic drugs.
Most have no pharmacopeia monographs.
Immunogenicity can be affected by various factors including manufacturing processes and impurities.
Marketing approval of biosimilars is a much more complicated
Disadvantages:
Biosimilars are less stable than chemical based pharmaceuticals and thus require cold chain distribution and have a shorter shelf life. This increases the cost and complexity of distribution. The cost of development will be significantly higher than for chemical-based generics.
Verifying similarity or comparability of a biosimilar with an innovator product therefore requires much more than demonstrating bioequivalence (which is sufficient for conventional generic drugs.)
As the complexity of the protein product increases, such as with
long-chain or heavily glycosylated proteins and monoclonal antibodies, more clinical data are required to fully characterize the clinical properties of biosimilars.
Service Offerings
BA/BE Studies First-in-Human Studies
Majority of biopharmaceutical products are approved through Public Health Service Act (PHSA
section 351) and biological license application. But ,there is no abbreviated pathway for approval of Generics . No existing statutory framework for approval of biosimilars.
PK/PD Studies Phase 1/2a PK Studies (Dose Response, Steady State, Food Effect, DDI) Controlled Substance studies QTc Studies Renal Studies Glucose Clamp Services Bio-Analytical Services for Small Molecules Method Development and Validation Japanese Bridging Studies Pharmacovigilance Support Services
New Drug Applications governed by Federal Food, Drug and Cosmetic Act (FFDCA). Hatch-Waxman
provisions provides an abbreviated new drug application (ANDA) pathway for generic small molecule drugs. Section 505(b) (2) of FDCA allows FDA to review and approve the same. Some protein drugs like insulin and human growth hormone are regulated under FFDCA.
6 successful US FDA Audits 2007 Frost and Sullivan's "Partner of Choice" for Phase I studies 2009 Frost and Sullivans Indian Clinical Research Organization of the Year Trusted CRO partner to 11 of the worlds top 15 Global Pharmaceutical Companies
After review of the application by EMEA, based on evaluation of quality , safety and efficacy they
award either a positive or negative opinion.
After getting a positive opinion on the product, European Commission (EC) will grant marketing
authorization valid for the European Union, who is the final decision maker for marketing approval of biosimilars.
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